Our Partner is hiring a Business Analyst.  In this role, you’ll be responsible for ensuring that the requirements of the business clients are captured and documented correctly before a solution is developed. The Business Analyst collaborates with diverse stakeholders to elicit, analyze, represent and validate requirements for changes to business processes, policies and information systems.  Ideally candidates will have specific experience working on initiatives in Finance / Accounting (familiarity with terms & concepts).
 
What you’ll do:

What you’ll bring:

#LI-TB1

Our partner is looking to bring in a Release Managers who will be responsible for developing, managing and organizing releases of different IT projects. They will collaborate and coordinate the implementation activities; focus on dependencies and relationship management; delivering products by bringing software and/or infrastructure as an integrated release package or solution. This will be a contract that will last at least a year. This opportunity is open for fully remote candidate with-in the US.

What You'll Do:

Release Management (75%):

 

Release Engineering/Automation (25%):

What You'll Bring:

 

Desired Skills:

#TB-LI
 

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.

TL;DR: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:

What you’ll bring:

 

 

#LI-TB1

Our Partner is hiring a Data Engineer to work with their Data Science and Integration team.  This team is made up of different specialists who play multiple roles: data scientists, data architects, data engineers, business analysts, and database administrators. They lend expertise to Integrating data, moving data, and providing insights into 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:

 

What you’ll bring:

 

#LI-TB1

Carex is seeking a motivated, career-minded Software Engineer – Java/Angular 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:

What you’ll bring:

Required:

Preferred:

Qualified candidates should also possess:

#LI-TB1

Carex is seeking a motivated, career-minded DevOps Software Engineer 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.

Be part of the Engineering Productivity team where you will have autonomy to design and develop technological advances. You’ll work in a very agile and collaborative environment establishing advanced methods, theories and research techniques that support the technical vision and strategy. We’ll look to you as a subject matter expert in multiple areas of technology that will represent your team in a positive manner. You’ll provide viable recommendations for new solutions and lead their implementation, ensure team commitments are established and met, and provide instruction and guidance to less senior team members on new tasks and assignments. Daily activities include collaborating with Architects and recommending adjustments to the architecture, improving overall product quality and integration efficiencies.

What you'll do:

 

What you'll bring:

Required:

 

Preferred:

 

Qualified candidates should also possess:

#LI-TB1

Our Partner is hiring a Sitecore Developer (remote).  In this role, you’ll provide leadership and development expertise as our partner evolves their Sitecore and web marketing ecosystem. The Sitecore XP v10 platform running on the Azure Cloud provides growth and learning opportunity for a developer looking to expand their skill base. Their web infrastructure serves as a common interface for customers who learn, shop and get support for their biotechnology and life science needs. Improving personalization capabilities, commerce experiences, and related reporting are all strategic goals. This role also includes responsibility for assisting with integrations to other platforms within the organizations environment, including MS Dynamics CRM, SAP, Widen and more.

What you’ll do:

What you’ll bring:

#LI-TB1

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.

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:

 

#LI-TB1

Our partner is looking for a Talent Acquisition Consultant that is able to manage the full recruitment life cycle for assigned position openings in a consultative manner. Focus on establishing and maintaining partnerships with hiring managers, utilize data to provide hiring strategy recommendations, and ensure positions are filled in a timely manner with the top talent required to support the business needs and objectives. They are looking for and individual who lives in the Wisconsin or Iowa area, hybrid preferred.

What You’ll Do:

What You’ll Bring:
 

Carex’s client partner is the leading manufacturer of luxury kitchen appliances and is a longstanding, family-owned company in the Madison area. Icons of design and paragons of performance and quality, this client partner is the refrigeration, cooking, and dishwashing specialists found in world’s most luxurious homes. They look for team members who are driven by innovation and excellence, striving to serve their customers by doing what is right—with integrity, teamwork, and accountability.

This partner is seeking to grow their Sales Operations team by bringing aboard a Sales Operations Specialist I.  You’ll be part of an exciting and dynamic company with a complex go-to-market strategy in the high-end consumer appliance space. 

What You’ll Do:

What You’ll Bring:

 

#LI-TB1

Our Partner is hiring a Senior Legal Counsel.  In this role, you’ll be charged with providing legal expertise to all levels of management in the conduct of company business and effectively build partnerships with business customers.  This role requires in-depth knowledge and experience in legal contracting, specifically technology and SaaS contracting.

 

What you’ll do:

 

What you’ll bring:

 

#LI-TB1

Our partner is looking for a Support Desk Technologist to assist to creates tickets in their ticket system, and provides basic troubleshooting and technical support for software and hardware systems. 

What you’ll do:

 

What you’ll bring:

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:

What You’ll Bring:

 

Preferred Experience:

Our partner provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the U.S. for a company.

 

#LI-TB1

 

 

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:

    1. Development of product marketing strategies.
    2. Function as commercial marketing expert.
    3. Support coordination of Product Management, market segment SBU and Sales/Branch marketing efforts.
    4. Monitor, analyze and recommend commercial marketing plans and tactics.
 

 

 

 

 

  1. 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.

 

 

 

 

OCCASIONAL DUTIES:

MANDATORY QUALIFICATIONS:

 

PREFERRED QUALIFICATIONS:

#LI-TB1

 

Our Partner is hiring a Business System Analyst.  This is a hybrid-based role located in Madison, WI (3 days onsite).  The Business Systems Analyst will provide technical production support to ensure smooth and efficient integration between technical and functional system requirements. The Analyst will provide consultative services to internal stakeholders across the organization regarding the identification of best practices as well as supporting the creation of solutions and documentation that best meet the Company's needs.

 

What you’ll do:

What you’ll bring:

#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:

What You'll Bring:

 

Apply Now and move your career forward with an exciting and highly respected biotech leader!
Questions? Contact Andie Veach directly at Andie@CarexScientific.com

 

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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Our partner is looking for a Contract Admin. They are looking for someone who will develop, negotiate and manage full life cycle of contracts to support strategic and construction projects. Analyze and negotiate key business and legal terms in a variety of contracts, including complex business transactions. 

What You'll Do:

What You'll Bring:  

#LI-TB1

Mobile Device / Desktop Technician

Carex’s partner, based in Madison, WI, is looking for a contracted mobile device technician to join their team on a 6-month contract with potential to extend. 

 

What you’ll do:

The main function of a MDM Administrator is set up and install new and replacement mobile (smart phone, tablet and laptop devices) and desktop devices, which includes imaging equipment and deploying necessary software, utilizing applications such as SCCM and Intune. Job Responsibilities: – Provide technical support on assigned Help Desk tickets (ServiceNow) in person and by phone – Assist in the software and hardware life cycle management processes including research, packaging, deployment and quality assurance validation – Support employees and business partners, both local and remote, with Mobile Device and Desktop issues, account issues, access to various internal services – Provide technical expertise in analysis and resolution of complex problems and take appropriate action to ensure maintenance of stated performance objectives to maximize system availability and minimize response time – Troubleshoot software issues on employees mobile devices/desktops – Some off hours support for may apply

What you’ll bring:

#LI-TB1

Carex’s healthtech partner in Madison, WI is on a mission to slash billions from healthcare costs.

They are searching for a Technical Support Engineer to join their team to assist with their AWS infrastructure and customer networking needs. The ideal candidate thrives on digging deep into technical issues and enjoys working with customers in the overall pursuit of strong relationships and high satisfaction. You’ll be engaging with challenging problems, collaborating on improvements to team tools and documentation, troubleshooting customer issues, and above all, making customer’s happiness a top priority. This position reports to the Manager of Technical Support.

What you'll do

Technical Support Engineers work deep in the guts of the system, ensuring customers have a world class experience. The entire support team is technically focused, and this position will work closely with the Infrastructure team in fulfilling customer connectivity and file delivery needs, as well as being tasked with AWS and other infrastructure work for the Support team. Your first project will be understanding and then redeveloping our partner’s site-to-site VPN solution, and training others on supporting it.

Responsibilities:

What you'll bring

Salary and benefits

 

#LI-TB1

Carex’s partner in Madison, WI, is looking for an engineer to help expand the capabilities of their software to parse and capture information from a wide range of documents. OCR, data engineering, NLP and machine learning are all leveraged to deliver to customers the solutions that drive their success. They are looking for additions to their tight-knit team that makes this all possible. They are looking for someone motivated to make such an impact. They value thinking outside the box, questioning existing solutions, and innovative alternatives. If this sounds like you, we’d love to hear from you!

What you’ll bring:

Other useful stills (helpful, not required)

 

This is a salaried position with the following benefits package:

 

#LI-TB1

 

 

 

 

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

#LI-AV1

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
 

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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Our Partner is hiring an IT Business Relationship Manager for their Distribution and Transportation division.  This Global Information Technology organization understands, supports and enables the business strategies, goals, and priorities. They are currently implementing substantial amounts of new technology including SAP S/4HANA, Integrated Business Planning, Product Life Cycle Management, Sourcing solutions and many other applications as part of the business transformation roadmap.  As a member of the IT Global Business Applications client-facing team you will act as a primary point of contact between distribution and transportation functions and IT to drive and implement technology needs that meet business requirements.

What you’ll do:

What you’ll bring:

#LI-TB1

Are you looking to use your Regulatory experience within IVD or Medical Devices at an admired company you can grow and be valued in? This could be the perfect role for you!

What You'll Do:

The Regulatory Affairs Lead will be an important part of the in vitro diagnostic new product development and realization teams from start to finish, making sure all regulatory compliance is met. You will work with cross-functional teams and external providers to ensure that the new and existing products comply with international standards and regulations. Demonstrated regulatory affairs experience with IVD/Medical Devices is crucial for this position..

Key responsibilities involve serving as the Regulatory Affairs Subject Matter Expert on New Product Development Teams for In Vitro Diagnostic Medical Device Projects, which include:
1. In collaboration with RA leadership and subject matter experts, evaluate regulatory impact of proposed products.
2. Research and evaluate regulatory requirements.
3. Provide regulatory guidance and assess regulatory implications for products throughout the product lifecycle.
4. Work with cross-functional teams to prepare regulatory applications, registrations, and submissions to regulatory authorities.
5. Maintain documentation needed to support regulated product throughout the product’s lifecycle.
6. Review and approve product labels (label disclaimers).
7. Review and approve product literature for compliance to applicable regulations.
8. Facilitate risk assessments for regulated products.
9. Evaluate risks based on regulatory factors, provide options and recommendations to mitigate risk.
10. Organize, facilitate, or lead meetings to discuss review findings and planning issues.
11. Provide regulatory support for other branches as needed.
12. Develop and conduct regulatory training, as needed.
13. Assist with writing SOPs as needed.
14. Provide regulatory input for complaint investigations and product recalls.
15. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
16. Embracing and being open to incorporating the company's Emotional & Social Intelligence (ESI) core principles in daily work.
17. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

What You'll Bring:

1. Bachelor’s degree in life science, chemistry, or other relevant field.
2. Minimum of 5 years regulatory experience with a graduate degree or 8 years quality regulatory work experience with a bachelor’s degree.
3. Good understanding of applicable FDA regulations and EU Directives.
4. Experience in writing and reviewing documents required to support regulated products.
5. Proficiency with basic word processing and spreadsheet software programs.
6. Ability to develop concise, clear communication and presentations that contain both analysis and possible solutions.
7. Proven ability to work effectively with a broad range of people, both internally and externally, to achieve results.
8. Effective communication skills.

Ideal (but not required) Qualifications:
1. Regulatory Affairs Certification (RAC).
2. Experience in developing EU Technical Files to support regulated product.
3. Experience in developing compliance files or submissions to support regulated product in other markets.
 

Apply Now and move your career forward with an exciting and highly respected biotech leader!
Questions? Contact Andie Veach directly at Andie@CarexScientific.com

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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Our Partner is hiring a NetSuite developer to join their Document Sales and Servicing (DS&S) Team who has experience with NetSuite CRM and ERP, strong technical skills, strong communication, is team and delivery oriented, and is passionate to continue to learn and grow along with other team members in an environment using agile frameworks.

 

What you’ll do:

 

What you’ll bring:

 

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Our Partner, a Wisconsin based healthcare software firm, is seeking to hire a Full Stack Software Developer.  The Full Stack Software Development Engineer is responsible for working with the development team to build, maintain, test and update new features as well as improve and support legacy code. The primary platforms the developer will be working on are the main web application, and an API service which provides connectivity to a native mobile application. The potential engineer should have experience configuring Azure services, with knowledge and/or a drive to learn healthcare information exchange standards.

 

What you’ll do:

 

What you’ll bring:

 

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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:

OCCASIONAL DUTIES:

What You'll Bring:

Preferred Qualifications

 

Take the next big step in your career and Apply Now!
Questions? Contact Ginger Auchter directly at Ginger@CarexScientific.com
 

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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Our Partner is hiring a lead OIPA Developer.  In this role you’ll develop code for OIPA (ORACLE Insurance Policy Administration) with focus on XML development of OIPA code to achieve business goals.

 

What you’ll do:

 

What you’ll bring:

 

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Are you a Process Validation Engineer with Process Validation Development and Execution experience within a Biotech, Pharma or similar manufacturing environment? If you're looking to join a leading Biotech company in the Madison area with a great team and lots of room for growth, this opportunity is for you!

What You'll Do:
This role is a key part of the Operations Validation Team. The team is made up of different specialists who play multiple roles including statistical data scientists, process validation engineers, and analytical method validation engineers that provide their expertise in all things Validation. This includes validating products, processes, analytical methods, and qualifying equipment that supports the Class 1 Medical Devices. The diverse internal clientele includes all areas of the company's Bulk Manufacturing, Customs Manufacturing and R&D business units.

In this role you'll have an opportunity to lead and execute validation and qualification activities of equipment and processes while working in a team environment. Independently draft, review, execute validation and qualification protocols per industry practices and internal guidelines. The position requires working knowledge and experience in the qualification of bulk manufacturing process equipment and facilities utilities. Experience with equipment and process validation is highly desirable. Additional key responsibilities include:

What You'll Bring:

PREFERRED QUALIFICATIONS (We encourage you to apply even if you do not have the following):

ADDITIONAL NEEDS OF ROLE:

 

Take the next big step in your career and Apply Now!
Questions? Contact Ginger Auchter directly at Ginger@CarexScientific.com
 

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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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:

  1. 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.).
  2. Review and assist in the development of reports, protocols, and SOPs for new and current products.
  3. Execute the following activities when appropriate:
    1. Review and approve batch records, stability data and validation results to ensure that products meet requirements.
    1. Review and approve technical literature content for accuracy and consistency.
    1. 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.
  4. Demonstrate leadership within the Product Quality Team.
  5. Act as QA lead on new product development cross-functional teams.
  6. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
  7. Embracing and be open to incorporating the company's 6 Emotional & Social Intelligence (ESI) core principles in daily work.
  8. Understand and comply with ethical, legal and regulatory requirements applicable to our business.

 What You'll Bring:

  1. Bachelor of Science degree in life science or chemistry.
  2. 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.
  3. Five (5) years Working knowledge of ISO13485 requirements. Direct experience working in an FDA regulated system.
  4. Proven ability to work constructively with a broad range of people, backgrounds, and functions.
  5. Ability to apply effective critical thinking skills in complex problem solving and decision making to achieve positive results.
  6. Ability to develop concise, clear written communication and presentations that contain both analysis and possible solutions.
  7. Ability to effectively prioritize and manage workload in an environment with frequent interruptions and changing priorities and timelines.
  8. Experience leading department or corporate projects in a positive team environment.
  9. 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

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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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

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