Our Wisconsin based partner is looking for a yearlong contract IT Analyst. This employee must be located in Wisconsin but is able to work in a hybrid environment.
This contractor will analyze, design, code, test, implement and maintain simple to moderately complex and smaller and more defined system projects, business applications, and purchased business systems using tools and products deployed on multiple technology platforms and on a corporate-wide basis. .
What You'll Do:
- Following general instructions, ensures critical review points and quality assurance controls are included in all application development projects
- Develops cost estimates associated with recommended system development solutions
- Assists in defining user stories and participates in workshops, data and process modeling, and prototyping sessions
- Assists in ensuring business and technical needs and opportunities are identified and satisfied throughout solution development
- Assists in the gathering and analysis of information required for proper technical design, including the identification and evaluation of purchased package solutions
- Works with data/database administration functions to ensure proper design of system databases and appropriate integration with other corporate data
- Assists with analyzing information and business process flows to integrate new applications with existing applications
- Performs testing for moderately complex systems, and assists other analysts in testing complex systems. Helps develop critical measures to test function and system performance improvements
- Assists business team in identifying training requirements to support application and other information technology use
What You'll Bring:
- Knowledge of Oracle's JCAPs tools and technologies Knowledge, Skills, and Abilities
- Demonstrated knowledge of concepts of information technology
- Demonstrated ability to implement standard analysis, programming, and testing techniques
- Ability to determine the use of appropriate current information processing technology, applies logical reasoning to moderately complex situations, and analyze problems of a moderately complex nature and derives workable solutions
- Advanced ability to develop and maintain business applications using application development tools as defined
- Demonstrated ability to use computer software programs (e.g., e-mail, word processing, spreadsheet, and project management)
- Demonstrated effective interpersonal, verbal, and written communication skills
Preferred Skills:
- Knowledge of SQL and relational database concepts. Ability to write complex queries
- Experience with Java, developing web services, SOA Administration, preferably in Oracle SOA Suite. Understand the concepts of keys, certificates
- Knowledge of Meter-2-Cash life cycle
- Knowledge of CC&B modules and Oracle Utility Application Framework (OUAF)
#LI-TB1
Our Partner is hiring a SAP Basis Systems Analyst. In this role, you’ll be responsible for requirements definition and documentation of computer networks and systems, translating general business requirements into concrete IT deliverables, process maps, and functional designs at an enterprise level.
What you’ll do:
- Identify the appropriate business leaders/contacts for various business applications
- Work directly with IT Owners, Infrastructure, and Vendors to fully understand the infrastructure requirements for applications, including (but not limited to):
- Performing technical infrastructure systems analysis
- Understanding On Prem vs SaaS vs IaaS and end to end infrastructure to produce detailed network diagrams with requirements from vendors, leveraging our existing infrastructure footprint
- Writing server build documentation & firewall rules that explicitly detail server names and requirements regarding storage, server build, SMTP, SFTP, active directory, etc.
- Following change control procedures and submit production/test changes; contribute to improvement of such procedures
- Facilitate discussions around As-Is and To-Be infrastructure design to support current and future systems landscapes
- Interface with Security team and analyze security needs within and across infrastructure platforms
- Identify how applications interface through the end-to-end business infrastructure
- Consolidate and Standardize information related to all aspects of current and future infrastructure architecture
- Map server list to specific infrastructure owners for future remediation needs
- Create/Analyze server migration strategies for domain separations or upgrades
- Experience with SAP BASIS implementation, ServiceNow, ITIL, change management
- Support end to end application implementation lifecycle through design, build, testing support, cutover prep, and hyper care activities with cross functional teams
- Ability to create documentation to support audit and reporting requirements
- Facilitate discussions around roles and responsibilities to document RACI and operational support models for applications
- Collaborate with other IT resources to develop, maintain, and adhere to common set of work practices focusing on maintaining an integrated operating environment
- Document specific requirements for infrastructure team for each application requiring IT Infrastructure
What you’ll bring:
- Bachelor’s degree in Business, Information Technology, or Computer Science; equivalent and applicable experience may be considered in lieu of a degree
- Minimum of 3 years of experience as a Business Analyst, Infrastructure Technician, Infrastructure Systems Engineer, or similar in an Information Technology Department is required
- Prior professional experience designing, building, and maintaining infrastructure systems for a large organization is preferred
- Business Analyst Certification (CCBA/CBAP) and working knowledge of BABOK is preferred
- Experience with SAP ERP software, Service Now, and SharePoint is preferred
- Working knowledge of Six Sigma and Lean methodology is preferred
- Must have experience in gathering and documenting requirements for large, complex applications
- Understanding of SAP ASAP methodology
#LI-Remote
Does FDA, PMA, MDSAP, EU-IVDR and CDx represent acronyms that you enjoy and are considered the go-to person in? Are you looking to be a part of the ground floor in an established company and help launch a CDx and Diagnostics solution that changes lives? This could be the exact role you're looking for!
This position can be either a Director or Senior Director role dependent upon candidate, and is responsible for leading the overall Regulatory Affairs strategy and direction for the company (premarket, adverse event reporting, recalls, regulatory policy and advocacy for the US and worldwide). The Senior Director / Director, Regulatory Affairs translates strategy into tactics, priorities, and resource requirements for execution of plan to assure successful implementation and ultimate success. A focus on overall team development is imperative for success in this position. The Senior Director / Director will lead the Regulatory Affairs teams in delivering world-class regulatory service to the business by creating and supporting a regulatory compliant culture by providing advice and counsel to business managers.
What You'll Do:
- Maintain a high degree of knowledge and awareness of the external environment and work with external associations & global regulatory bodies to remain current. Proactively adapt regulatory strategies and influence change within areas of responsibility.
- Identify regulatory trends in the region and their implications for the company, taking into consideration the impact on business decisions.
- Ensure compliance with applicable regulations (US FDA QSRs, Europe IVDD/IVDR, Health Canada regulations, MDSAP requirements, ISO 13485, etc.).
- Manage global registrations with internal and/or external resources.
- Analyze and communicate proposed, new, or changing requirements, lead teams to develop strategies to implement and sustain compliance requirements. Oversee all programs and processes to meet business objectives and ensure compliance with regulatory requirements.
- Evaluate performance metrics to identify program opportunities, recommend and initiate improvements in procedures or oversight.
- Mentor, coach and teach direct and indirect reports on activities within areas of responsibility. Effectively manage the recruitment, development, training, and performance management of direct reports.
- Educate, train, advise and coach company professionals among cross functional teams to ensure compliance with RA requirements.
- Work collaboratively with other departments, managers, and staff throughout all branches to ensure a consistent approach to regulations is adopted throughout the business.
- Lead and support continuous improvement activities regarding areas of responsibility.
- Represent the company in interaction with regulatory agencies.
- Contact customers directly about quality issues or questions as directed.
- Organize and implement training programs in areas of Regulatory Affairs.
- May lead and/or direct other areas related to Quality Systems, e.g., CAPA, Nonconforming, Internal Audit as needed.
- Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
- Understands and complies with ethical, legal and regulatory requirements applicable to our business.
What You'll Bring:
- MS Degree in a science or engineering related field or equivalent work experience.
- 15+ years of Regulatory experience in the medical device industry.
- 7+ years of leadership experience, including training and coaching team members.
- Expert knowledge and experience applying global device laws & regulations for product registration, adverse event reporting, & recalls.
- Class I, II and III medical device experience. Experience with CDx products a significant plus.
- Experience in PMA, 510K submissions, including leading resubmission meetings with the FDA.
- Regulatory Affairs Certified (RAC).
- Demonstrated ability to lead cross-functional teams.
- Advanced knowledge and experience managing regulatory issues and interfacing with local and international regulatory bodies, such as FDA, European competent authorities and notified bodies, Health Canada, SFDA, KFDA, etc.
- Ability to prioritize, plan, delegate and evaluate deliverables to established strategic goals.
- Demonstrated experience operating in a highly regulated environment.
- Excellent verbal and written communication and presentation skills with the ability to influence and make recommendations at all levels of the company.
Ideal Qualifications:
- Experience supporting IVD products.
- Experience in supporting regulatory strategy for CDx products.
Take the next big step in your career and Apply Now!
Questions? Contact Andie Veach directly at Andie@CarexScientific.com
About Us
At Carex, We Are Career Matchmakers.
Your ideal career is out there. Carex curates the best opportunities for top candidates and makes it easier for both job seekers and employers to find their ideal fit.
Carex Scientific, a division of Carex Consulting Group, works exclusively with scientists throughout the U.S. and across a spectrum of backgrounds and industries. We are Scientists placing Scientists and focus on building long-term partnerships and helping candidates find their ideal next step. At Carex, Candidates are people and fellow professionals, not metrics.
Carex is a Certified Minority-Owned & Woman-Owned Business. Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.
To see all of our available opportunities, visit Carex at: /candidates/see-job-openings/
#LI-AV1
Carex is seeking a motivated, career-minded Software Engineer – Java to utilize their skill set in a thriving agile-methodology environment. Our partner offers competitive career advancement opportunities, a comprehensive benefits package and promote a work-life balance. Our partner is a SaaS business-to-business solution that enhances the customer experience.
You will be responsible for using your technical knowledge of professional concepts to solve business problems. We’re looking for talented individuals who can serve as subject matter experts in their area of focus and represent their departments on complex assignments for our Smart Assignment team. You’ll be responsible for evaluating elements of technology’s effectiveness through requirements gathering, testing, research and investigation, and offer recommendations for improvements that result in increased quality and effectiveness. You’ll listen to and evaluate customer needs to determine and provide high quality solutions that align with their expectations.
What you’ll do:
- Participate in tactical initiatives such as designing, developing and reviewing code with the opportunity to be part of strategic visioning, introducing new technologies, design, improved metrics, and process improvements
- Be part of the full application lifecycle (design, develop, test, deploy and maintain), innovating in each step
- Designing API’s and working with other teams to build integrations
- Develop full slices of the application from the UI to the data store
-
Share responsibility with your teammates for occasional after-hours on-call rotation for support of production level systems
- Design, develop, execute, and maintain complex automated test code, scripts, data, and associated drivers per recognized SDLC methodology
- Participate in and lead design and code reviews
What you’ll bring:
Required:
- Must be presently authorized to work in the U.S. without a requirement for work authorization sponsorship by our company for this position now or in the future
- Minimum, high school diploma or GED
- Must be at least 18 years of age
- Occasional travel to company offices or meetings as required
- For flexible or full remote work from home positions, reliable high speed internet connection and dedicated work space are required
- Must be located in one of the following locations: AZ, CA, FL, IL, LA, MD, MI, MN, MO, NJ, NV, NY, OH, OR, TN, TX, VA, WA or WI
- 3+ years of professional experience in application development at an enterprise level. (post-graduate)
- 2+ years of experience in SQL or NoSQL DB structures, experience with DB migration scripts (SQL Server, MySQL, Mongo)
- 2+ years of experience with object-oriented programming language including Java
- 2+ years of experience in front-end technologies, to include JavaScript, Typescript
- 2+ years of experience with front-end development frameworks such as Angular or REACT (Angular preferred)
- Candidate must express ability and eagerness to learn Angular if no experience
- Experience creating applications in cloud-based and cloud native development environments (ex. Azure, AWS, Google, Kubernetes)
Preferred:
- Advanced degree (Bachelor’s or Master’s) in Computer Science, Computer Information Systems, Management Information Systems, or a related field OR 6+ years of relevant IT experience OR IT Boot Camp graduate
- Exprience in Angular
- Experience creating and consuming API’s or experience developing web services
- Experience developing software in a SaaS environment using CI/CD and DevOps methodology
- Automated test development and execution (for example, REST-assured, Selenium, etc)
Qualified candidates should also possess:
- Experience in an Agile working environment
- Behaviors that demonstrate ability to keep current on technology trends
- Evolving communication and collaboration skills
- Experience with designing new methods and working with existing patterns in a previous role
#LI-SR1
Carex is working with a Madison area partner who is in need of a IT Systems Administrator. The System Administrator position will focus on maintaining the internally facing systems that several hundred windows-based staff use. This position involves a dynamic work environment where any given day can include working in Active Directory, Office 365, SharePoint, Scripting, Security, and Network troubleshooting. This is a great opportunity for someone that welcomes the ability to cross IT boundaries and not be siloed into a single job function.
What you’ll do:
- Infrastructure and Systems Administration
- Management of all Active Directory integrated systems (O365, Azure, Jira, Okta, etc.)
- Owning and coordinating small to mid-sized technical projects and improvement initiatives.
- Manage and administer Microsoft 365 products (SharePoint, Teams)
- Setup and configure new user accounts, manage e-mail distribution groups, as well as create and assign permissions to appropriate applications.
- Create and maintain complex PowerShell automation scripts ranging from on/offboarding scripts, monitoring scripts, and other temporary scripting solutions.
- Security and License auditing (Active Directory, License auditing, file share ACLs, Office 365, etc.)
- Network Management
- Help manage and provide technical support for network systems, including firewalls, switches, VMware, and workstations.
- Perform diagnostic analysis of the network system, identify possible faulty devices, troubleshoot faulty modules, troubleshoot network problems and prepare necessary documentation detailing actions taken.
- Cybersecurity Systems Administration
- Actively monitor networks, cybersecurity systems, and other notifications during and after hours.
- Help manage and monitor Total Live Care system monitoring.
- Help manage and monitor Arctic Wolf security operations center.
- General
- Manage the computer imaging deployment servers (WDS, MDT)
- Support, maintain, and troubleshoot issues on office equipment, such as printers, copy machines, and other devices.
- Effectively handle outages and client escalations, reporting to IT leadership and sending company-wide communications in a professional and positive manner.
- Create and/or maintain existing end-user support documents, including FAQ’s, Wiki’s, and training guides.
- Work with vendors to ensure routine maintenance and repairs are done on IT equipment (servers, battery backups, printers, etc.).
What you’ll bring:
- Required
- 4+ years of hands-on system administration and technical support.
- Technical/IS/Associate’s Degree (completed or in-progress) or equivalent training in Information Systems, Computer Science or related field.
- Demonstrated experience managing Active Directory and group policy deployments in a Windows environment.
- Working experience managing Microsoft 365 solutions (SharePoint, Teams etc.).
- Previous experience managing an automated workstation imaging deployment process, preferably Windows Deployment Services (WDS) and Microsoft Deployment Toolkit (MDT).
- Strong working knowledge and familiarity in scripting languages, such as PowerShell, Bash, etc.
- Experience with, and knowledge of, networking concepts (any certifications is a plus).
- Strong knowledge/experience of workstation support in a Microsoft Windows environment.
- Strong analytical and troubleshooting skills, you must be passionate about root cause analysis. “Just reboot it” is not always the answer.
- Must be just as comfortable working in a team setting as you would be working independently.
- Strong customer service skills.
- Strong people skills – ability to both listen and communicate effectively.
- Strong organizational skills and detail oriented.
- Preferred
- Bachelor’s Degree in Information Systems, Computer Science or related field.
- Admin experience with Jira or experience working in any ITSM tool.
- Knowledge of Cisco Firewall configuration.
- Knowledge of VMware Administration.
- Experience with cybersecurity systems.
Microsoft Dynamics Low-Code Developer (REMOTE/CONTRACT)
Carex’s partner, the leading manufacturer of luxury kitchen appliances worldwide is looking for a Low-Code software developer to support their Microsoft Dynamics and Power Automate initiatives in 2023. This is an opportunity to use modern technologies, work in fast-moving sprints with a collaborative team, and participate in rapid innovation in a dynamic industry.
What you’ll do:
- Manage configuration of MS Dynamics and Power Automate tools to create and iterate customerfacing applications to support Sales efforts
- Build and support workflow automations
- Write Javascript and/or C# code to support more complex requirements
- Work on API’s with other missioncritical applications
- Perform all or part of the software development life cycle and follow a methodology.
- Reviews, analyzes, and modifies programming systems including coding, testing, debugging and installing to support an organization's application systems.
- Gather data and analyze business and user needs in consultation with both business managers and endusers
- Must be able to work independently and as a part of a development team working on small, medium, large and enterprise projects.
- Analyze business application requirements for functional business areas.
- Gather business requirements and develop specifications for software solutions
- Possess strong interview skills. Interview project stakeholders, document findings and make detailed recommendations.
- Has knowledge of commonlyused concepts, practices, and procedures within a particular field.
What you’ll bring:
- Must be detail oriented, have strong analytical and problemsolving abilities.
- Must understand and conceptualize applications from both a technical/programming perspective and a business point of view.
- Demonstrated ability to write Javascript and/or C# code to support APIs
- Experience with Microsoft Dynamics and preferably MS Power Automate tools
- Familiarity with tools such as ServiceNow and Jira
This position has is a 6-month contract term, with likely extension for successful candidates, and the potential to convert to a full-time employee for the right fit.
#LI-WR1
Our Partner is looking for a JIRA Administrator contractor to join their team for a least a year with the possibility to get extended. Our Partner is in the insurance industry and is hoping to bring in a mid-level contractor.
What You'll Do:
- Manage (create/update) workflows
- Manage (create/update) screens
- Create automation rules
- Support Jira/Confluence add-ons (EazyBI, ScriptRunner)
- General user support
- Create Jira queries (JQL)
#LI-TB1
Do you have a background managing a Controlled Substances pharmaceutical or similar program, and expertise working with the DEA and regulatory guidelines? Are you looking to move your career forward and grow with a leading Biotech company? This could be the role you are looking for!
Join a team that consists of innovative professionals with diverse skillsets who work together to achieve the goal of safely manufacturing high-quality small molecules that are used in numerous Life Science products to improve lives around the globe.
WHAT YOU'LL DO:
The Controlled Substance Scientific Program Manager is responsible for the implementation of an emerging Controlled Substance program to ensure compliant manufacturing and distribution of clinically relevant psychedelic medicines. This role will provide subject matter guidance in the development of processes and procedures to uphold regulatory requirements and best practices. DEA regulated business activities include research, development, analysis, and API and drug product manufacturing at multiple registered locations including a correlated non-profit Institute.
Key Responsibilities:
- Monitor the performance of the controlled substance program to understand and mitigate compliance risk. Communicates with cross-functional stakeholders and proposes improvements to the program.
- Work in close partnership with site leadership, QA/RA, Logistics, Manufacturing, and lab staff, providing technical guidance and support with activities involving with controlled substances.
- Write and maintain procedures and forms related to controlled substances.
- Develop and deliver training to employees.
- Manage registration applications and renewals for all Federal DEA Registrations and State licensures.
- Ensure security and access procedures and policies are adequate and maintained.
- Coordinate and manage processes and documentation required for movement and transfers of controlled substances throughout manufacturing and operations.
- Manage inventory reconciliation processes for all controlled substances at the registered sites. Responsible for investigating all inventory discrepancies of controlled substances. Leads investigations into the loss or theft of controlled substances.
- Review manufacturing batch records and other cGMP documentation related to controlled substances as required.
- Complete quarterly ARCOS, biennial, and year-end inventory reports for controlled substances as required by the DEA.
- Develop and maintain all documents required for DEA quota applications, approvals, tracking, and amendments.
- Execute, file, track, and audit DEA Form 222 order forms for both procurement and supply activities.
- In coordination with logistics, complete DEA import and export permit applications via the DEA IMEX portal.
- Conduct internal audits, following up on findings and corrective actions.
- Lead external DEA inspections, interfacing with governmental agencies such as federal and state DEA representatives.
- Coordinate the destruction activities for all controlled substances with lab staff, QA, EH&S, and Logistics and approve destruction methods in accordance with DEA requirements.
- Maintain proper record keeping.
- Demonstrate inclusion through words and actions and be accountable for a safe workspace. Act with kindness, curiosity and respect for others.
- Understand and comply with ethical, legal and regulatory requirements applicable to the business.
WHAT YOU'LL BRING:
- Minimum High School diploma; BS in science or similar degree preferred.
- 5-8 years direct DEA compliance experience or pharmaceutical experience that includes working directly with controlled substances.
- Keen awareness and technical knowledge of DEA regulations and how they are applied in a pharmaceutical manufacturing environment.
- Ability to build relationships by communicating effectively and thoughtfully, using diplomacy and tact.
- High degree of initiative with demonstrated ability to work independently and meet timelines. Ability to be calm when situations are stressful or ambiguous.
- Able to adapt to changes in priorities based upon shifting business needs.
- Ability to utilize tools and technologies to create seamless business interactions, connections, and transparency.
Preferred Qualifications:
- Familiar with working in a cGMP environment and compliance with FDA regulations.
- Proficiency in inventory management and other controlled substance compliance systems (SAP, CSOS, etc.).
If you're looking for a great opportunity and growth in your career apply now!
Questions? Contact Andie Veach at andie@carexscientific.com
About Us
At Carex, We Are Career Matchmakers.
Your ideal career is out there. Carex curates the best opportunities for top candidates and makes it easier for both job seekers and employers to find their ideal fit.
Carex Scientific, a division of Carex Consulting Group, works exclusively with scientists throughout the U.S. and across a spectrum of backgrounds and industries. We are Scientists placing Scientists and focus on building long-term partnerships and helping candidates find their ideal next step. At Carex, Candidates are people and fellow professionals, not metrics.
Carex is a Certified Minority-Owned & Woman-Owned Business. Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.
To see all of our available opportunities, visit Carex at: /candidates/see-job-openings/
#LI-AV1
Our Partner is hiring a Project Manager with strong COTS experience. Ideally, you’ll have experience working with SAP, EDI, COTS, Data warehouse and Analytics. The project manager will work with Business Partners, Resource managers, Individual Contributors, IT Governance, and Senior Management to deliver projects on-time, within established budget, and within approved scope. You’ll work with Business Partners and cross-functional teams to manage, communicate, and escalate as necessary issues and risks.
What you’ll do:
- Manages and directs cross functional project teams on IT projects.
- Develops, coordinates, and maintains integrated project timelines for all assigned projects.
- Facilitates the IT definition of project scope, goals, deliverables, project tasks and resource requirements.
- Aligns with business project owner on scope of project.
- Responsible for IT resource planning, IT guidance, budget estimation, and change control.
- Facilitates project oversight meetings and daily scrum meetings to discuss issues, risks, project status, business engagement, testing, and implementation. Communicates risks, issues, and progress back to the business program manager.
- Works closely with program managers and functional leaders to ensure projects meet all metrics including quality, savings, budgets and schedules.
- Works with resource managers and individual contributors to identify and assign the right resource at various stages of the project life cycle.
What you’ll bring:
- Minimum of 5 years of experience in a combination of areas such as operations, program/project management, finance, information technology, ERP Systems, Application Development, or IT Infrastructure
- COTS (commercial off the shelf) implementation experience
- Project Management Certification (PMI) a plus
- Working knowledge of IT project finances including capitalization
- Experience with SAP ERP software, Service Now, MS Project, and SharePoint preferred
#LI-TB1
#LI-Remote
Carex's partner is a healthcare IT company in Madison focused on helping customers automate document processing. Demand continues to build for their products, and they are poised for further growth in the expanding market for healthcare data solutions. Their software and services are helping to reduce healthcare costs and improve physician decision making at some of the largest and best-known names in healthcare. Their expanding list of marquee healthcare customers means they need your help to further expand the power and capability of our software.
Our partner works with the largest local governments as well as the most prestigious healthcare organizations across the country. If improving patient care, reducing healthcare costs, complying with quality mandates, or helping researchers discover new treatments excites you, send us your resume. We’re looking for people with passion.
What you’ll do:
We’re looking for technical professionals with the skills to become a member of our partner’s Data Capture Analysis team.
- You will work closely with the support, sales, and engineering teams to define customers’ project requirements and to create and fine-tune text mining algorithms and document workflow solutions.
- You will delve into the world of machine learning and leverage it to train software to read documents like a human being. Your work will have a direct influence on c’stomers' success.
- Employees who excel in this role have the opportunity to grow into a software developer or technical project manager.
What you’ll bring:
- You have lots of energy and a passion for thrilling customers.
- You have a technical curiosity and have always wanted to know how things work.
- You are interested in text analytics and machine learning technologies.
- Analytical and creative mindset.
- Strong attention to detail, well organized, and can manage multiple projects simultaneously.
- Excellent problem solving and analytical skills.
- At least 1 year of experience programming or scripting in any language.
- Experience with regular expressions or pattern matching constructs.
- Excellent problem solving and project management skills.
- Ability to think outside of the box and create new processes when needed.
Preferred experience and skills
- Prior experience with AI and/or Machine Learning.
- Bachelor's or greater in Engineering, Math, Statistics, Physics, Chemistry, MIS/CIS, Informatics, or other science-related field.
#LI-TB1
Our Partner is looking for an experienced IT Auditor that is brought in to develop, plan, and lead the execution of internal audit programs for the organization to ensure compliance with best practices and the organization's policies, procedures and standards.
What You'll Do:
- Proactively identifies and analyzes risks to the organization.
- Partners with second lines of defense to identify risk from internal and external sources.
- Completes Internal Audit’s Risk Assessment to document risks and controls.
- Creates test plans and complex audit programs to assess the design and operating effectiveness of key controls.
- Conducts test procedures as outlined in detailed audit program. Documents and analyzes test results, identifying areas of concern and documenting findings
- Use statistical methods, modeling, and sampling techniques to assess the adequacy of processes and controls.
- Identifies, documents and communicates control deficiencies and other activities to management.
- Documents, monitors, and ensures appropriate implementation of management action plans.
- Provides consulting to business partners on risks and controls and ways to strengthen the control environment.
- Monitors engagements against budget, scope and timeline, and develops corrective action plans when necessary.
- Ensures that work is completed in accordance with internal auditing standards (IPPF) and Enterprise Internal Audit procedures.
- Manages more complex projects or multiple concurrent projects.
- Identifies, plans and implements continuous improvements to Internal Audit processes.
- Participates in the development of and ensures adherence to documented standards and procedures.
What You'll Bring:
- In-depth conceptual and practical knowledge in own job discipline and basic knowledge of related job disciplines
- Ability to solve complex problems
- Ability to work independently and receive minimal guidance
- Comfortable being a resource for colleagues with less experience
Our partner is hiring a REMOTE Data Engineer for their Data Science and Integration team. They are made up of different specialists who play multiple roles: data scientists, data architects, data engineers, business analysts, and database administrators. They provide our expertise in all things data! From Madison, WI or anywhere remotely, the Data Engineer provides oversight and development around the implementation of a modern data platform solution. You will design, develop, modify and support data solutions in Azure and on-premises environments. You are also a key contributor in modeling, developing, enhancing, and supporting curated data models.
The Data Engineer designs, develops, enhances, and supports data solutions with an Azure/cloud-first architecture approach.
What You’ll Do:
1. Design, develop, modify, and support data solutions in Azure and on-premises environments.
2. Design and develop scalable, efficient (internal and external) data pipeline processes to handle data ingestion, cleansing, transformation, integration, and validation.
3. Model, develop, enhance, and support curated data models.
4. Ensure standards are met so that solutions deployed have technical integrity and stability.
5. Design and develop automated Data Quality solutions that ensures the integrity of a modern data platform.
6. Document production software, runbooks, and solution architectures.
7. Develop, communicate, and present solution architectures to both technology and business stakeholders.
8. Support critical strategic initiatives and architect simple to complex data engineering projects.
9. Collaborate with IT peers to understand the Data Landscape across the organization.
10. Collaborate with Data Scientists, Data Analysts and Business Stakeholders to deliver curated data models.
11. Build cross-functional relationships with Business Stakeholders, Architects, Data Scientists, BI Managers, and Business Partners to understand data needs and help projects and agile teams deliver on those needs.
12. Deliver collaborative products that align with organizational strategies.
13. Mentor junior level engineers and cross team peers in all levels of data engineering.
14. Work with other IT teams to write and maintain technical and en-user documentation and provide training.
15. Provide off-hours (24×7) support for Data Systems as required.
16. Stay up on current technologies and industry trends.
17. Provide other duties as assigned.
18. Demonstrate inclusion through their own words and actions and be accountable for a safe workspace. Act with kindness, curiosity and respect for others.
19. Embrace and be open to incorporating 6 Emotional & Social Intelligence (ESI) core principles in daily work.
20. Understand and comply with ethical, legal and regulatory requirements applicable to our business.
What You’ll Bring:
1. Bachelor’s degree in computer science or relevant science discipline.
2. 5+ years’ experience as a Data Engineer or equivalent role.
3. Working knowledge of Data Engineering tools like Databricks, Synapse, Spark, PySpark, Scala, Data Factory, SSIS, Informatica.
4. Comfortable in building effective analytical tools that utilize the data pipeline to provide actionable insights into data synchronization and operational efficiency of the data repositories.
5. Experience in designing database models to store structured & unstructured data efficiently and in creating effective data tools for analytics experts.
6. Advanced knowledge in relational databases, like MSSQL, MySQL, Oracle, etc.
7. Knowledge of and ability to implement CI/CD best practices especially as they relate to data engineering.
8. Experience in defining and setting up data architecture to support data warehousing and business intelligence.
9. Working knowledge on enterprise data lakes, data analytics, reporting, in-memory data handling, enterprise integration tools, etc.
10. Having an owner’s mindset and experience working in a fast-paced and demanding environment.
11. Ability to work in an Agile development environment.
Nice to have’s:
1. Microsoft Azure experience, especially in the data engineering space.
2. Knowledge of no-SQL databases, Azure cosmos DB, MongoDB, Elastic Search, etc.
3. Knowledge on enterprise data lakes, delta lake, data analytics, in-memory data handling, enterprise integration tools, etc.
4. Knowledge of open source tools like NiFi, Kafka, Airflow, etc. specifically on the Azure cloud platform.
5. Working knowledge of message queuing, stream processing, and highly scalable ‘big data’ data stores.
6. Proven ability in working in an agile team environment, anticipating, and meeting team needs, working with little direction, and gaining cooperation from others.
7. Experience and/or training in designing, developing, supporting, and maintaining business application software, including extensive end-user contact.
8. Ability to work in a fast-paced, environment with frequent changes in priorities and assignments.
PHYSICAL DEMANDS:
1. Ability to use a personal computer and manipulate software to accomplish required tasks as outlined above daily including keyboarding skills.
2. Ability to distinguish different colors and shades, tints, and tones of color which is essential for graphical design work.
3. Availability to occasionally work overtime hours to complete assignments during peak work-load periods.
Diversity is important. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.
#TB-LI
Our Partner is hiring an SAP Program Manager for a multi-year engagement. In this role, you’ll help deliver program success through effective team and initiative management while working with various global stakeholders and leaders.
What you’ll do:
- Lead and manage project team consisting of IT, Business, Partner and PMO resources – deploying them effectively to support/enable successful program delivery
- Develop best practices, scalable mechanisms and repeatable processes on all aspects of the transformation
- Ensure proper communication and change management processes are adopted for all major change initiatives, identifying other potential priorities and/or interdependencies
- Responsible for overall management and delivery to customers of all projects under the SAP 4HANA Program
- Ensures that projects within the Program are completed on time and within budgeted cost and profitability targets
- Drives end to end Program implementation involving interaction with multiple stakeholders
- Anticipates issues and needs of the customer related to the Program and addresses them proactively
What you’ll bring:
- SAP and/or Oracle ERP implementation experience
- 7+ years of experience in leading complex projects locally, regionally, and globally
- Proficiency developing high-level and detailed program and project level activity/task work plans, schedules, staffing plans, and work-effort estimates
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#LI-Remote
Carex’s partner, based in Madison, WI, is the leading manufacturer of luxury kitchen appliances. Icons of design and paragons of performance and quality, our partner is the refrigeration, cooking, and dishwashing specialist found in world’s most luxurious homes. They look for team members who are driven by innovation and excellence, striving to serve customers by doing what is right—with integrity, teamwork, and accountability.
The Data and Analytics Team within the Information Technology department provides enterprise data engineering, analytics, reporting, visualization, and predictive analytics solutions. The team utilizes a wide variety of advanced tools and technologies and works directly with a diverse community of leaders and stakeholders.
Growth and development are important aspects of this position. Whether you aspire to be a leader or a technical expert, this position will set you up for success in the future.
What you’ll do:
The Data Engineer II participates in the design, development, testing, and implementation of a variety of data pipelines and solutions. They build and support near real-time and batch process data pipelines, ensuring high quality and availability of the data. They create and maintain complex relational, dimensional, and other data structures based upon analytical need and data modeling best practices. A high degree of collaboration across business stakeholders and technical peers is crucial.
- Partner with domain architect and peers to evaluate data engineering methods and tools
- Design, build, and operationalize scalable data pipelines using a variety of technologies, across a multitude of sources and targets
- Assemble large, complex data sets that meet functional and non-functional business requirements
- Deploy code using multitier CI/CD framework
- Develop iteratively within the Agile Scrum methodology and participate in Scrum ceremonies
- Communicate well and work directly with stakeholders to support User Acceptance Testing
- Participate in on-call production support rotation
- Train and mentor peers
What you’ll bring:
Required
Bachelors or better in Computer Science or related field.
3+ years of progressively responsible development experience required.
Preferred
Diverse understanding of reporting and analytics built from prepared data
Experience developing in a cloud-based environment using cloud data services (Microsoft Azure preferred)
Experience with designing and developing various data models (e.g. relational, dimensional modeling, star schema)
Extensive experience with data replication and engineering tools (e.g. FiveTran, dbt, Snowflake, Azure Data Factory)
Demonstrated knowledge of SQL and data analysis techniques
Benefits:
- Competitive compensation based on skills
- Industry leading health, dental, and vision plans
- Generous 401 (K) savings and profit sharing
- On-site Health clinic, fitness center, and walking paths
- Education assistance and internal training programs
- Electric vehicle charging
- Maternity & paternity leave
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Specialist, Benchtop Solutions
Carex’s partner is a publicly-traded clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, their therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Our partner’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
They are seeking a Madison, WI-based Specialist, Benchtop Solutions to join their team for a direct-hire position.
Job Summary
The Specialist, Benchtop Solutions will be a “hands-on” technician responsible for all lab computer solutions for the research community at large, reporting to the Director of Research Informatics. As Carex’s partner rapidly grows, there is an increase in critical laboratory instrumentations that requires interfacing with their infrastructure. This critical role will support all existing laboratory instruments in their integration with Infrastructure. The Benchtop Specialist will need to understand instrument systems, security, architecture, operating systems (windows and linux), network, Cloud implementations and instrument specific software as pertaining to the instrument. The primary goal of the team is to keep instruments functional and productive at all times.
What You’ll Do:
- Provide smooth instrument operations in all research sites
- Build relationships with Research as well as Information Systems team to become a trusted advisor and partner.
- Work with Research Informatics and the greater IS & Informatics team to remove roadblocks and continue its growth as a high-performing team.
- Manage Vendors and Consultants to optimally deliver Solutions to the research team in optimizing costs and timelines for projects.
- Be a main point of contact and facilitator for all instrument computer systems related activities, not including functions and operation of instruments.
- Work with Vendors and InfoSec to integrate new instruments into the network compliantly.
- Manage instrument licenses and renewals.
- Maintain central data management software such as Labsolutions or Nugenesis in the capture, management of remote instrument control and raw data transfer.
- Work with Information Security to maintain instrument PC patching and testing of patches as required.
- Upgrade Instrument PCs or Windows OS as needed.
- Administrate and manage users on required systems.
- Develop instrument automation processes as necessary by user requirements and needs.
- Apply industry level Agile Project Management and Software Development Life Cycle (SDLC) Practices to manage installations and systems.
What You’ll Bring:
- Bachelor of Science Degree in Computer Sciences or related field (or Associates Degree and 5+ years’ experience in Information Technology or related laboratory role)
- Minimum 3 years of experience working with instrument systems.
- Experience and knowledge in Windows OS, AWS cloud instance deployments, Active Directory, Systems Security, Systems Architecture, PC Hardware interfaces, Network
Preferred Experience:
- Experience working in the Life Sciences industry
Our partner provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the U.S. for a company.
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Our partner in the biotech space is looking to add a Strategic Commercialization Manager (or Sr. Manager!) to the team. You'll work in conjunction with Product Managers to develop, plan, communicate, execute, and monitor worldwide commercialization strategies (short and long-term) and marketing tactics for the Strategic Portfolio Management (SPM) product portfolios using clearly defined goals, objectives, critical success factors, timelines, budgets, and metrics.
Responsible for managing the programs and communications about our products and services to internal and external customers in assigned portfolio area(s). Translate and coordinate Strategic Business Unit (SBU) market segments strategies and goals into SPM commercial plans and activities. Work closely with branch marketing and marketing services to ensure successful adoption and execution of global commercialization plans and activities.
What You'll Do:
- Develop and implement cohesive go-to-market strategies and commercialization tactics for the assigned portfolio of products to maximize product revenue growth and achieve forecast goals. Areas of focus include:
-
- Development of product marketing strategies.
- Function as commercial marketing expert.
- Support coordination of Product Management, market segment SBU and Sales/Branch marketing efforts.
- Monitor, analyze and recommend commercial marketing plans and tactics.
- Collaborate with Product Management, Marketing Services, and SBU market segments to use input from customer needs and competitive landscape to create overall messaging strategy and promotional tactics to maximize product portfolio revenue.
- Propose product marketing strategies and obtain buy-in from Portfolio and Product Manager(s), SBU Marketing and Branch Marketing on commercial marketing and tactical plans. Define and manage tactical plans for new product introductions and legacy products which may include website refinement, e-marketing campaigns, printed brochures, sales tools, press releases, and public relations to meet business objectives, deadlines, and budget.
- Develop, communicate, and implement global commercial marketing plans that include market assessment, situation analysis, product/technology positioning and elements of marketing mix (product, price, promotion, distribution) based on product/technology value proposition to achieve product and portfolio goals. Develop and execute:
- Detailed tactical plans and metrics for product launches and legacy products.
- Marketing collateral in support of new and legacy products.
- Campaigns / themes and support tools for trade shows and conferences.
- Analysis of competitor commercialization activities and tactics and recommendations for strategic counter tactics.
- Working with Product Managers and market segment SBUs, provide input into new product development processes and strategic product roadmaps including situation analysis, SWOT, product/technology positioning, market size, customer segmentation, and pricing as appropriate to help ensure market fit and define market potential for new product concepts.
- Lead logistics for development of materials and campaign/theme selection for global or branch promotions. Collaborate with sales channels on requests for special promotional programs or training; work with internal marketing and technical staff to evaluate requests and recommend/implement action plans.
- Network with sales, branches, distributors, and customers to understand needs/motivators to use for developing the most effective regional and global promotions. Collaborate with sales management and Branch Marketing Managers to plan and coordinate product/technology commercialization efforts aligned with marketing strategies.
- Develop and communicate training and presentations about campaigns/promotions and marketing strategy to branches, direct sales, distributors and/or internal staff. Participate and/or present in sales and marketing meetings.
- Identify metrics and measure effectiveness of marketing tools and programs. Create and communicate metrics including ROI for all promotional programs.
- 10. Working with product management, create and manage the overall SPM marketing budget based on the yearly planned commercialization activities across the entire portfolio. Create the budget for assigned areas associated with commercialization tactics. Analyze expense results, trend lines, identification, and explanation of exception items. Regularly monitor tactic performance based on target metrics and make recommendations for plan adjustment in budget and activities based on data driven results.
- Understands and complies with ethical, legal, and regulatory requirements applicable to our business.
OCCASIONAL DUTIES:
- Support SPM management for special projects or duties.
- Lead, identify and appraise commercial opportunities which may be significant technology collaborations or acquisitions.
- The individual may also have accountability for certain Product Management, Global Strategic Marketing activities associated with the portfolio.
MANDATORY QUALIFICATIONS:
- BS in life science field required.
- MBA or equivalent business and marketing experience.
- 5 or more years’ experience in life science marketing.
- Ability to comprehend and present intermediate level molecular biology techniques.
- In-depth understanding of marketing functions including strategic and tactical marketing, marketing communications, market research, distribution channels, competitive intelligence, and customer communications.
- Strong public speaking skills needed to represent our partner at external meetings, conferences, and organizations. Able to present high-level information for multiple audiences ranging from scientist to marketers.
- Attend industry trainings, workshops, conferences, focus groups and other activities associated with commercialization tactics as a presenter or representative.
- Proven ability to analyze issues, think strategically and creatively and execute innovative ideas for the product/portfolio in the target market segment.
- Demonstrated effective written and verbal communication skills.
- Demonstrated ability to work on multiple detailed projects and assignments simultaneously and independently.
- Proficient in Windows PC based environment and MS Office
PREFERRED QUALIFICATIONS:
- Five or more years’ experience in marketing management of molecular biology products or services.
- Global knowledge of local cultures and business practices needed to successfully market to the applied sciences market segments.
- Sales experience.
#LI-TB1
Do you have a strong background in a pharma pilot plant setting working with encapsulated or tablet-based Drug Product Development? Want to build your own Program and work in a brand-new facility of a global Biotech leader with amazing Scientists and Engineers as colleagues? This Program Manager – Drug Product Development could be the perfect role for you!
What You'll Do:
The Program Manager – Drug Product Development is responsible for working closely with clients in Custom Products and supporting both their internal Drug Development activities, as well as working with outside contractors to move the products forward. This will include:
- Driving multiple drug product development programs in conjunction with cross-functional project teams. The candidate will have a broad knowledge of regulatory, scientific, and technical issues concerning drug development applications in the USA, Europe, and other global markets.
- Define, align scientific and regulatory strategy, manage, and execute drug product programs utilizing both external vendors and internal capabilities.
- Work with external partners including CROs and CMOs and regulatory agencies.
- Author and review technical documents in support of regulatory submittals and preparation of submission ready sections. Manage input with internal team of individuals, consultants, and SME’s as part of regulatory submission process.
- Oversee CROs and CMOs as a technical expert and coordinate contract work to ensure projects adhere to established timelines and technical specifications.
- Facilitate API and finished drug product (dosage form) development activities including biochemical and biophysical characterization, formulation development, and extractable/ leachable studies, etc.
- Prepare presentations, organize meetings, and collaborate with other scientists and departments.
- Identify issues that may delay timely completion of critical project tasks and escalate as needed.
- Work cross-functionally and communicate effectively across functional areas and collaborate across the organization to help identify/develop new external development capabilities.
- Lead projects/programs managed by the Product Launch and Change Planning (PLCP) function.
- Provide understanding of cGMP and global regulatory requirements for drug product development and manufacturing.
- Manage and resolve conflict within the project team. Lead cross-functional teams within Process Development across all modalities and across all commercialization stages as needed. Facilitate and incorporate lessons learned and standard methodologies.
- Draft timeline scenarios to enable/adjust project execution across multiple development paradigms to inform portfolio decisions.
- Play a critical role in the resource/financial management and forecasting of individual projects on an ongoing basis.
- Demonstrate a continuous improvement mindset: proactively seek out, recommend, and implement process improvements.
- Apply project management best practices in the initiation, planning, execution, control and closing of projects.
- Understand and comply with ethical, legal, and regulatory requirements applicable to our business.
What You'll Bring:
- Degree in pharmaceutical sciences, chemistry, chemical engineering, biology, or related sciences.
- Minimum 10+ years industrial experience in a pharmaceutical setting with specific focus on drug product development.
- Experience with methods for the biochemical and biophysical characterization of small and large molecules and dosage forms of various nature, including capsule and IM.
- Excellent technical written and oral communication skills.
- Good organizational skills and ability to meet challenging project deadlines among competing priorities.
Apply Now and move your career forward with an exciting and highly respected biotech leader!
Questions? Contact Andie Veach directly at Andie@CarexScientific.com
About Us
At Carex, We Are Career Matchmakers.
Your ideal career is out there. Carex curates the best opportunities for top candidates and makes it easier for both job seekers and employers to find their ideal fit.
Carex Scientific, a division of Carex Consulting Group, works exclusively with scientists throughout the U.S. and across a spectrum of backgrounds and industries. We are Scientists placing Scientists and focus on building long-term partnerships and helping candidates find their ideal next step. At Carex, Candidates are people and fellow professionals, not metrics.
Carex is a Certified Minority-Owned & Woman-Owned Business. Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.
To see all of our available opportunities, visit Carex at: /candidates/see-job-openings/
#LI-AV1
Do you have an advanced degree in Optical Engineering and experience working with Bioanalytical products? Have a passion for new product development and want to grow in your career with an innovative and well-known Biotech company? This could be the role you're looking for!
What You'll Do:
Within this role you'll be able to work with a team of engineers and scientists in the US and South Korea with diverse backgrounds and experiences. Projects have included the development of chemistries and instruments designed for a wide range of scientific disciplines and an ability to constantly be involved in new endeavors, evaluating new technologies, and pursuing new approaches to develop the next generation of instrumentation.
In this senior role, you'll be able to use your deep knowledge of physics/engineering to define the optical characteristics of the analytical and detection instrumentation under development, and support the vitality of existing products. The catalog of luminescence-based biological assays typically requires low-light detection that can utilize a wide variety of detection modalities depending on the instrument. The fluorescence-based assays may also require the development of LED or laser-based excitation and single or multiplexed signals for detection.
You'll be part of the team to develop cutting edge integrated systems for biological sample analysis. Boasting both assay and instrumentation development, the company offers the unique opportunity to create integrated systems that bring industry leading performance to the scientific community. Acting as an expert in the design, development, and testing of optical systems for high performance bioanalytical instrumentation, you can be part of an active team bringing innovation to life at a company with a commitment to mindfulness and continued personal and professional growth.
What You'll Bring:
1. Act as a Key Contributor on cross-functional engineering teams to achieve project deliverables. Collaborate with scientists, product management, industrial designers, and others to understand user needs and address those needs in designs.
2. Design, develop, build, and test optical systems used in complex bioanalytical instruments. Illumination sources may include LEDs, lasers, solid state lasers, and conventional lamps. Detectors may include solid-state devices, photomultipliers, and cameras. Systems will include both imaging and non-imaging optics. Spectral regimes will typically span near-UV, visible, and near-IR (200nm to 1200nm).
3. Design and/or specify optical components such as lens, imagers, reflectors, filters, gratings, and detectors, both off-the-shelf and custom. Interface with vendors for optical components, both standard and custom.
4. Analyze and optimize system performance considering, for example, optical and mechanical tolerances, thermal issues, and detector signal-to-noise.
5. Collaborate closely with mechanical and electrical engineers.
6. Perform hands-on work with optical components and systems. Personally perform construction and test of optical prototypes, or supervise technicians doing this work.
7. Where appropriate, apply software simulation tools for optical analysis and optimization.
8. Use current best-practice tools, design methods, and production approaches. Remain current in technology through self-directed reading, training, trade shows, and networking.
9. Plan and develop optical test procedures in conjunction with engineering and production to verify quality requirement guidelines. Specify and design optical alignment and test equipment for both development and production.
10. Use analytical and troubleshooting skills to address instrumentation systems issues. Conduct root cause failure analysis to improve instrument performance and reliability. Perform detailed technical analyses and create test and analysis reports.
11. Provide clear organized documentation to be used by other engineers, production, suppliers, consultants, and regulatory agencies. Prepare and present work at design reviews.
12. Understand and comply with ethical, legal, and regulatory requirements applicable to our business.
KEY QUALIFICATIONS:
1. PhD degree and 4 years of experience is preferred. To be successful in this role, experience should be in developing optical systems and products. It is desirable that the advanced degree be in optics.
2. Expertise in specifying, modeling, analyzing and optimizing optical components and systems.
3. Expertise in measurement and test of optical components and systems.
4. High level of proficiency with one or more optical design software tools such as LightTools, CodeV, Zemax, ASAP, or Trace Pro.
5. Excellent conceptual, analytical and problem solving abilities.
PREFERRED QUALIFICATIONS:
1. Experience with both imaging and non-imaging optics is highly desirable.
2. Experience and skill in electronics is desirable, particularly as related to optical sensors and detectors.
3. Experience with Matlab, Rhino, SolidWorks and similar modelling software is desirable.
4. Experience and skill in mechanical engineering, particularly as related to mounting and alignment of optical components, is desirable.
5. Experience with LEDs and fluorescence systems is highly desirable.
6. Experience in development of analytical instrumentation for biological/chemical applications and/or medical devices in a regulated environment (e.g. ISO-13485 or FDA QMS)..
If you're looking to take that next big step in your career, Apply Now!
Questions? Contact Becky Hines at Becky@CarexEngineering.com
About Us
At Carex, We Are Career Matchmakers.
Your ideal career is out there. Carex curates the best opportunities for top candidates and makes it easier for both job seekers and employers to find their ideal fit.
Carex Engineering, a division of Carex Consulting Group, works exclusively with engineers throughout the U.S. and across a spectrum of backgrounds and industries. We are Engineers placing Engineers and focus on building long-term partnerships and helping candidates find their ideal next step. At Carex, Candidates are people and fellow professionals, not metrics.
Carex is a Certified Minority-Owned & Woman-Owned Business. Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.
To see all of our available opportunities, visit Carex at: /candidates/see-job-openings/
#LI-BH1
Are you well-versed in quality control and analytical methods within API production? Looking to find an entrepreneurial role within a well-established and respected biotech/pharma company? This could be the perfect next step in your career!
What You'll Do:
The Senior Quality Control Analytical Scientist, Pharma will play a cornerstone role in the development, characterization, validation, and implementation of analytical methods for the manufacture of Active Pharmaceutical Agents (API) in a brand new CMC facility. Some of the key responsibilities include:
Independently perform and oversee all aspects of analytical method development, method validation and method implementation.
Write, review and revise, as necessary, inspection plans, test methods, SOPs and other QC department procedures, for accurate and complete content, and ensuring they meet documentation policy.
Evaluate and interpret analytical testing results. Act as primary reviewer of analytical data generated from raw materials test, in process testing, and final product testing.
Collaborate with Manufacturing and R&D to develop analytical methods for API manufacturing.
Perform laboratory investigations for Out of Specification results or other testing abnormality. Investigate complaints from customers and internal deviations/nonconformances as assigned.
Report results of release testing according to company Quality System requirements. This includes the input of results into SAP Quality Module and issuing COA’s as needed.
Prepare and/or maintain QC testing materials, retention samples, and reference standards.
Maintain a working knowledge of QC Lab instrumentation and associated analytical methods utilized for product release testing.
Perform analytical method evaluation and/or re-validation upon request, as part of installation, operation, performance qualification efforts related to new or changed laboratory instrumentation.
Support internal and external customers to ensure that proper and timely execution of all aspects of the clinical analytical method life cycle.
Provide training on QC methods and instrumentation in the laboratory, as needed.
Demonstrate inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
Understand and comply with ethical, legal and regulatory requirements applicable to our business.
What You'll Bring:
Master’s or Ph.D. degree in Analytical Chemistry, M.S. with approximately 10+ years, or Ph.D. with approximately 8+ years in a Quality Control lab performing method development, validation and implementation related to API testing.
Extensive knowledge on the use and troubleshooting of typical analytical instruments, including HPLC, NMR, GC, ICP-MS, MS/QToF, Karl Fisher, and XRPD.
Experience in all aspects of analytical method development, method validation and method implementation related to API testing. This includes experience with the use of statistical tools to analyze data.
Experience writing and reviewing Inspection Plans, test methods, SOPs and other QC Dept procedures, for accuracy and complete content, and ensuring they meet documentation policy.
Strong knowledge of current regulatory guidelines and cGMP requirements.
PREFERRED BUT NOT REQUIRED QUALIFICATIONS:
Ph.D. with 2+ years or M.S. with 8+ years’ analytical method development experience in a pharmaceutical company.
Experience in preparing regulatory submissions and responding to regulatory inquiries.
Take the next big step in your career and Apply Now!
Questions? Contact Andie Veach directly at Andie@CarexScientific.com
About Us
At Carex, We Are Career Matchmakers.
Your ideal career is out there. Carex curates the best opportunities for top candidates and makes it easier for both job seekers and employers to find their ideal fit.
Carex Scientific, a division of Carex Consulting Group, works exclusively with scientists throughout the U.S. and across a spectrum of backgrounds and industries. We are Scientists placing Scientists and focus on building long-term partnerships and helping candidates find their ideal next step. At Carex, Candidates are people and fellow professionals, not metrics.
Carex is a Certified Minority-Owned & Woman-Owned Business. Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.
To see all of our available opportunities, visit Carex at: /candidates/see-job-openings/
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Our partner is looking for a Solutions Analyst. Typically their days consist of working with a cross-functional team supporting various external- and customer-facing technologies, with specific focus on contact center telephony software. They are looking for a yearlong contractor.
What You'll Do:
- Following general instructions, ensures critical review points and quality assurance controls are included in all application development projects
- Develops cost estimates associated with recommended system development solutions
- Assists in defining user stories and participates in workshops, data and process modeling, and prototyping sessions
- Assists in ensuring business and technical needs and opportunities are identified and satisfied throughout solution development
- Assists in the gathering and analysis of information required for proper technical design, including the identification and evaluation of purchased package solutions
- Works with data/database administration functions to ensure proper design of system databases and appropriate integration with other corporate and contact center data
- Assists with analyzing information and business process flows to integrate new applications with existing applications
- Performs testing for moderately complex systems, and assists other analysts in testing complex systems
- Helps develop critical measures to test function and system performance improvements
- Assists business team in identifying training requirements to support application and other information technology use
- Required to participate in an on-call support rotation
- Occasional after hours and weekends are expected
- May interact with security and infrastructure areas to recommend appropriate security and control factors and infrastructure requirements for applications
- Performs work under the direct supervision of a Manager.
What You'll Bring:
- Education Level Field of Study Required/Preferred Bachelor's Degree Information Technology Preferred Required Experience
- 3 years of contact center support related experience. Preferred Experience
- Knowledge of cloud and/or on premises contact center applications and technologies
- Knowledge of CRM solutions and contact center integrations with those solutions
- Knowledge, Skills, and Abilities
- Demonstrated knowledge of concepts of information technology
- Demonstrated knowledge of telephony/customer contact center technologies, including IVR, call routing, and call recording
- Demonstrated ability to implement standard analysis, programming, and testing techniques
- Ability to determine the use of appropriate current information processing technology, applies logical reasoning to moderately complex situations, and analyze problems of a moderately complex nature and derives workable solutions
- Advanced ability to develop and maintain telephony business applications
- Familiarity with relational databases (SQL Server/Oracle)
- Familiarity with Windows Server and Linux/Unix platforms
- Demonstrated effective interpersonal, verbal, and written communication skills
- Ability to work effectively in a diverse work environment
#LI-TB1
If you're well-versed in Digital Building Automation Control Systems and BAS programming, and have great project management skills, we have an exciting opportunity for you! Come join a thriving Biotech leader as a Building Automation Engineer and grow into the SME across the organization when it comes to Building Automation needs!
Note this role is based out of Madison, WI; full relocation is available. We are not able to consider candidates located outside the United States at this time.
What You'll Do:
As part of the facilities team, you will love working with different groups of individuals ranging from outside vendors to internal customers. With the growing number of buildings on campus, you will collaborate with resources to design, troubleshoot, or manage, facility-related building automation needs. This role will be integral in providing building automation and project management support for Facilities Services to meet organizational goals and objectives. Role responsibilities include:
- Provide engineering support to facilities maintenance staff with building system operations.
- Assist with troubleshooting and analysis of system deficiencies.
- Engage equipment vendors, engineering consultants and contractors to provide operational improvements or solutions for building system operational deficiencies.
- Share knowledge and perspectives on building system operations with maintenance staff to help develop and expand expertise and understanding of systems.
- Manage a wide variety of facility projects from start to finish.
- Work with customers and stakeholders to help define needs and solutions.
- Assess change control impact on qualified systems and work with customers, stakeholders, and quality assurance team.
- Work with management to develop cost estimates and schedules with customers, stakeholders and facilities resources to deliver the projects in a timely and cost effective manner.
- Coordinate resources with facility maintenance supervisor and/or outside contractors for project implementation.
- Provide project management direction and assist in decision making to ensure successful project implementation.
- Collaborate with vendors, engineering consultants, or company facilities to develop design BAS drawings.
- Leads small to medium size capital projects as required by management team decisions.
- Develop and implement control sequences of operation and programming.
- Assist in selection of components for project designs.
- Update project drawings with as-built system conditions.
- Assist project engineer manager and facility maintenance staff with the management of campus building systems.
- Assist with operational management of security, fire alarm, fire protection and safety systems.
- Proactively identify and correct potential safety and security issues as necessary.
- Assist in commissioning or recommissioning of new and existing systems to verify and document functional performance.
- Train and develop skills in the use of the building automation system to provide operational support for maintenance staff. Assist facility engineer manager and maintenance supervisors in the management of the building automation system.
- Maintain/Manage BAS as-built documentation of building system changes for future reference.
- Provide engineering support for project engineer manager to assess and manage operational efficiency of building systems.
- Identify and recommend opportunities for improved efficiency and cost savings.
- Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
- Understands and complies with ethical, legal and regulatory requirements applicable to our business.
OCCASIONAL DUTIES:
- Represent the company in project discussions/interactions with vendors, consultants, contractors.
- Present updates on corporate projects/programs to leadership or company employees as required.
What You'll Bring:
- Minimum Bachelors Degree in a technology related field and 5 years experience with digital building automation control systems in a facilities management or construction related environment.
- Minimum 2 years experience with BAS programming.
- Demonstrated knowledge and experience of building systems and equipment including HVAC, electrical, plumbing, and fire protection systems, steam and hot water boilers, chillers and refrigeration systems, constant volume and variable volume air handling systems, building automation systems and control sequences.
- Demonstrated ability to manage and successfully accomplish multiple complex projects simultaneously.
- Must possess a valid driver’s license.
- Experience with IP and BACnet networking.
Preferred Qualifications
- Independent self-starter with proven analysis planning, engineering troubleshooting, and project management skills.
- Ability to work and communicate well with a diverse scientific, business, and tenant staff, and respond quickly and professionally to understand and meet their needs.
- Experience in a facility with laboratory areas. Experience in engineering related facilities management projects.
- Excellent oral and written communication skills.
- Demonstrated new construction management experience, from design to completion.
- Experience with HVAC & Central Plant system controls by Siemens (Insight/Desigo CC)
- Create, revise, and edit project drawings using the latest version of AutoCAD.
Take the next big step in your career and Apply Now!
Questions? Contact Ginger Auchter directly at Ginger@CarexScientific.com
About Us
At Carex, We Are Career Matchmakers.
Your ideal career is out there. Carex curates the best opportunities for top candidates and makes it easier for both job seekers and employers to find their ideal fit.
Carex Engineering, a division of Carex Consulting Group, works exclusively with engineers throughout the U.S. and across a spectrum of backgrounds and industries. We are Engineers placing Engineers and focus on building long-term partnerships and helping candidates find their ideal next step. At Carex, Candidates are people and fellow professionals, not metrics.
Carex is a Certified Minority-Owned & Woman-Owned Business. Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.
To see all of our available opportunities, visit Carex at: /candidates/see-job-openings/
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Do you have significant QA experience in In Vitro Medical Devices and are looking for a leading biotech company you can continue growing your career in?
This high level QA Scientist role is made for you!
What You'll Do:
In this role you'll play a key role in assuring product quality and compliance to quality system requirements (QSR) pertaining to the manufacture of in vitro diagnostic medical devices.
Key Responsibilities:
- Work independently and with cross-functional teams to assure QSR compliance with applicable regulations (US FDA 21CFR820, Europe IVDR, Health Canada regulations, MDSAP requirements, ISO 13485, etc.).
- Review and assist in the development of reports, protocols, and SOPs for new and current products.
- Execute the following activities when appropriate:
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- Review and approve batch records, stability data and validation results to ensure that products meet requirements.
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- Review and approve technical literature content for accuracy and consistency.
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- Assess the scope and inventory impact of nonconforming product situations; approve disposition plans of inventory product on hold and assist in the disposition planning for nonconforming product.
- Demonstrate leadership within the Product Quality Team.
- Act as QA lead on new product development cross-functional teams.
- Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
- Embracing and be open to incorporating the company's 6 Emotional & Social Intelligence (ESI) core principles in daily work.
- Understand and comply with ethical, legal and regulatory requirements applicable to our business.
What You'll Bring:
- Bachelor of Science degree in life science or chemistry.
- Minimum of 7 years’ experience that includes time spent working in Medical Device industry. Experience should be in manufacturing, process development, quality control or quality assurance.
- Five (5) years Working knowledge of ISO13485 requirements. Direct experience working in an FDA regulated system.
- Proven ability to work constructively with a broad range of people, backgrounds, and functions.
- Ability to apply effective critical thinking skills in complex problem solving and decision making to achieve positive results.
- Ability to develop concise, clear written communication and presentations that contain both analysis and possible solutions.
- Ability to effectively prioritize and manage workload in an environment with frequent interruptions and changing priorities and timelines.
- Experience leading department or corporate projects in a positive team environment.
- Proficiency with basic word processing and spreadsheet software.
Preferred (Not Required) Experience:
1. Direct experience in quality field related to in vitro diagnostic medical devices.
Apply Now and move your career forward with an exciting and highly respected biotech leader!
Questions? Contact Andie Veach directly at Andie@CarexScientific.com
About Us
At Carex, We Are Career Matchmakers.
Your ideal career is out there. Carex curates the best opportunities for top candidates and makes it easier for both job seekers and employers to find their ideal fit.
Carex Scientific, a division of Carex Consulting Group, works exclusively with scientists throughout the U.S. and across a spectrum of backgrounds and industries. We are Scientists placing Scientists and focus on building long-term partnerships and helping candidates find their ideal next step. At Carex, Candidates are people and fellow professionals, not metrics.
Carex is a Certified Minority-Owned & Woman-Owned Business. Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.
To see all of our available opportunities, visit Carex at: /candidates/see-job-openings/
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Senior Scientist / Orbitrap Mass Spectrometry Expert
Get in on the Ground Floor of a Fully Funded, Innovative Drug Discovery StartUp!
This is an exciting opportunity to join a fully funded, venture-backed startup whose mission is to accelerate the discovery of lifesaving therapeutics.
You’ll be joining a company that is a contract research organization that provides analytical research services for drug discovery, specifically targeting the $300 billion antibody therapeutics market. We’ve reduced analysis time from the industry standard of 6-12 months to only 2-3 weeks and are completely changing the market!
Our patented, cutting-edge technology has significant advantages over the existing technologies available in the market today. We have an established pipeline of pharmaceutical customers including big pharma, clinical-stage biotechnology companies and research institutions. We have assembled a talented group of PhD-level scientists, including leading experts in biochemistry, who are passionate about revolutionizing drug discovery to improve patient outcomes.
What You’ll Do
Our Scientists at make an impact on day one. We are a fast-paced, entrepreneurial organization without the bureaucracy of a traditional life sciences business. As an early employee, you will collaborate with other top scientists to solve real-world customer problems to advance drug discovery. You will have the opportunity to shape the future direction of the organization and the potential to manage a team of scientists as the business grows.
Our Technology
Our founders developed a patented technology called Plasma Induced Modification of Biomolecules (“PLIMB”). PLIMB is a mass spectrometry-based technique for epitope mapping and protein structural analysis. Over the last 5 years, the NIH, NSF, WARF, and others have invested $1.4 million in PLIMB’s research and development, product development, and application testing. Our technology is customer-ready today and has been validated by pharmaceutical customers.
What You’ll Bring
· Minimum 4+ years of experience and strong expertise in LC-MS protein analysis
· Ph.D. in analytical chemistry, biochemistry, or related field
· Deep understanding and proven experience in LC-MS instrumentation and troubleshooting
· Experience in proteomic LC-MS method development and analysis
· Ability to work independently and collaborate with team members
· Ability to identify bottlenecks and unmet needs in analytical characterization workflows and develop solutions for customers
· Entrepreneurial mindset with interest in taking a leadership/management role
· Exceptional time and project management skills with the ability to own and manage multiple projects in a changing environment and meet timelines
· Excellent communication skills and ability to speak, present and write clearly and accurately
· Willingness to travel to conferences and customer site visits
Additional Ideal Skills
· Experience or understanding of the following techniques
oHydrogen/Deuterium Exchange (HDX):
oHydroxyl radical protein footprinting (HRF)
oChemical cross-linking mass spectrometry (XL-MS)
oSite-specific labeling MS
oGlycoprotein analysis with MS
oIn-silico structural modeling
oProtein expression and purification
oMembrane protein expression and purification
oMutagenesis
oSEC-MALS
oELISA
oProtein-protein interaction and in vitro binding assays
· Experience and/or familiarity with in-silico protein structural analysis and visualization.
· 2+ years of industry experience, especially in the field of antibody drug discovery/development
· Hands-on experience with Thermo Orbitrap technology
· Familiarity with Protein Metrics software
· Business experience and interest
· Demonstrated experience in developing strong customer relationships and project management
Overall Responsibilities
· Lab and instrument design and setup
· Develop and optimize HDX, HRF, XL-MS (and others as described above) experiments for the following applications:
oEpitope mapping
oProtein-protein and protein-small molecule interactions
oStructural analysis
· Visualize complex proteomics datasets
· Technical presentations to clients and at conferences
· Manage customer projects
· Author scientific papers
· Write grant funding proposals
· Future potential of managing a team of analytical and biological chemists
This position is based in Madison, WI and includes a full relocation package for applicable candidates. Excellent compensation package includes salary, benefits package, stock options and performance bonuses (both cash and stock options).
If you’re looking to unleash your expertise and follow your dream of being on the ground floor of an amazing startup, contact us today!
Questions? Email Ginger Auchter directly at ginger@carexscientific.com
About Us
At Carex, We Are Career Matchmakers.
Your ideal career is out there. Carex curates the best opportunities for top candidates and makes it easier for both job seekers and employers to find their ideal fit.
Carex Scientific, a division of Carex Consulting Group, works exclusively with scientists throughout the U.S. and across a spectrum of backgrounds and industries. We are Scientists placing Scientists and focus on building long-term partnerships and helping candidates find their ideal next step. At Carex, Candidates are people and fellow professionals, not metrics.
Carex is a Certified Minority-Owned & Woman-Owned Business. Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.
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To see all of our available opportunities, visit Carex at: /candidates/see-job-openings/
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