We're looking for a consultative Construction Manager to take on an onsite position responsible for large-scale construction projects with our partner based in Madison, WI.
- Full-time, 6-month contract
- BS + 8 years of professional construction management experience
- 3 years of supervisory experience
What You'll Do:
The Construction Manager will oversee contractor evaluation and selection, safety measures, and quality control, among others. They will also monitor project progress and implement project processes in a timely, safe, and environmentally conscious manner. Key responsibilities of the role include:
- Manage field personnel, monitor Contractor and Sub-Contractors activities, identify construction specification errors, ensure construction aligns with contract specifications and applicable codes.
- Promote a safety culture across the project and company. Coordinate with the safety department for accident and safety incident investigations, communicate findings to management, administer and monitor safety programs, and perform safety assessments.
- Measure and standardize performance using quality control and assurance processes. Use this information for process improvement (cost control, scheduling, executing, safety, etc.).
- Regularly update stakeholders about construction progress related to safety, production, risk, schedule, finance, and quality. Report any situations requiring immediate management attention.
- Collaborate with external contractors and equipment manufacturers, assist the site permitting process, manage equipment selection, project design specifications, development of project schedules, and cost estimates.
- Represent the project to local governments and communities, understand and enforce rules set by regulatory bodies (e.g., DOT, OSHA, DNR).
- Interact daily with internal project teams and customers, and supervise employees.
- Develop and ensure the completion of project Punch List, verify milestones and quantities submitted by the contractor for payment, assist in field problem resolution.
- Ensure the quality of construction through continuous monitoring of the construction and installation QC process.
What You'll Bring:
- Bachelor's Degree (Preferred)
- 8 years of professional experience in construction-related roles (management, project controls, QA/QC)
- 3 years of supervisory experience
- Experience in large electric construction, gas and electric operations, project management, or related area (Preferred)
- Valid driver's license
- Demonstrated project management skills
- Experience with labor union management (Preferred)
- Knowledge of safety rules and applicable building codes
- Understanding of construction standards, work methods, equipment, maintenance practices, and materials
- Ability to read and understand maps, plans, and drawings
- Demonstrated management skills
- Financial skills including budget development, financial report interpretation, and financial evaluations
- Excellent interpersonal, verbal, and written communication skills
- Proficiency in computer software programs (e.g., e-mail, word processing, spreadsheet, and project management)
Apply Now and move your career forward with a great team and continually growing leader!
Questions? Contact Becky Hines directly at Becky@CarexEngineering.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.
#LI-BH1
Looking to take the next big step in your career with a highly successful specialty chemical manufacturer focused on Active Pharmaceutical Ingredients (APIs)? This could be the role you're looking for!
– Fulltime, direct hire Chemical Facility Maintenance Technician onsite in Madison, WI
– 10+ years of experience in a chemical manufacturing environment and working with industrial scale glass reactors and similar equipment.
What You’ll Do:
The Chemical Facility Maintenance Technician will be a key leader in the maintenance and safe operation of key equipment within the chemical synthesis process. The Chemical Facility Maintenance Technician will perform scheduled maintenance and repairs within a Class 1 / Division 1 Active Pharmaceutical Ingredient (API) manufacturing facility. This individual will also be in charge of vendor and contractor relationships as needed. Key responsibilities and activities include:
- Perform standard maintenance on equipment used for plant scale chemical synthesis (e.g., 2000 L glass-lined reactors, vacuum pumps, drying ovens, glass condensers, and filter dryers.
- Perform repairs and manage specialized contractors to perform needed repairs.
- Working with the Engineering and Chemistry teams, execute preventive maintenance and service to equipment used to support the manufacture of APIs.
- Maintain equipment including:
- Glass-Lined Reactors
- Repair and inspection of drain valve
- Calibration of temperature probes and pressure gauge
- Inspection and change out of gaskets and seals
- Inspection and measurement of glass integrity for thickness and imperfections
- Acid Gas Scrubber
- Inspection and change out of caustic soda reservoir.
- Inspection and change out of column packing media.
- Calibration of pH meter and controller
- Heat Exchangers for Reactors
- Inspect and replace heat exchanger for hard water buildup.
- Check, maintain appropriate levels and change oil as needed.
- Filtration System
- Inspect integrity of piping and change parts as needed.
- Change oil filters on vacuum pumps.
- Check, maintain appropriate levels and change oil on vacuum pumps.
- Friction Aire Drying Ovens
- Calibrate thermocouples.
- Inspect and change gaskets as needed.
- Floor Balances
- Level or adjust support carts.
- Calibrate on a scheduled basis.
- Material Transfer Pumps
- Rebuild as needed.
- Level or adjust support carts.
- Inspection and changeout of gaskets
- Freezer System
- Calibration of temperature readout
- Filter changeout
- Nitrogen Generator
- Testing proper flow to reactors
- Water Supply
- Inspection and repair of plumbing supplying water to cooling towers.
- Inspection of sprinkler system
- Inspection of safety shower and eye wash station
- Mobile Fume Hood
- Filter testing
- Changeout of HEPA filter
- Concentrate Mix Tanks
- Inspection of drain valves
- Inspection of agitator motors
- Agitated Filter Dryer Systems (Nutsche)
- Ensure proper mechanical operation.
- Inspection and routine preventative maintenance
- Completion of United States EPA RCRA Hazwoper Training.
- Glass-Lined Reactors
What You’ll Bring:
- AS or higher in Industrial Maintenance or a similar degree.
- 10+ years experience in a chemical manufacturing environment, with prior experience in maintenance of glass-lined chemical reactors and other similar equipment.
- Demonstrated success working within and performing maintenance on equipment that manufactures highly toxic API substances, and within reactor rooms that routinely employee highly flammable materials. All candidates must have hands-on experience and strong knowledge of safety measures required for operating within chemical synthesis spaces.
- Ability to read and understand mechanical and electrical schematics is required.
- This position will also use equipment including hand and power tools, spark tester, welding equipment, forklift, electrical test devices, full-face respirator and self-contained breathing apparatus (SCBA) when required.
Apply Now and move your career forward with a great team and continually growing leader!
Questions? Contact Becky Hines directly at Becky@CarexEngineering.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.
#LI-BH1
Looking to take the next big step in your career with a highly successful specialty chemical manufacturer focused on Active Pharmaceutical Ingredients (APIs)? This could be the role you're looking for!
– Fulltime, direct hire Chemical Facility Engineer onsite in Madison, WI
– 10+ years of experience in organic chemical synthesis, ideally in small molecules / APIs
– Opportunity to help lead research and implementation of new manufacturing facility!
– Compensation for this position is anticipated to start at $90,000+ annually.
What You’ll Do:
The Chemical Facility Engineer will help manage the manufacturing chemistry process of active pharmaceutical ingredients (APIs) within the manufacturing facility, as well as have the opportunity to help transfer it to a new building and design the process itself! This role will directly lead the maintenance and functionality of equipment in the primary API chemical manufacturing facility, as well as serve as the lead for equipment and facility maintenance that supports the operations team. The Chemical Facility Engineer will play a key leadership role in helping to develop, design, implement and troubleshoot these processes to maximize productivity and product quality while minimizing costs and waste. Key responsibilities and activities include:
- Ensure that all equipment in the facility is in safe and proper working order.
- Develop proper preventative maintenance schedule and documentation system.
- Schedule the routine calibration and perform troubleshooting of instrumentation as needed.
- Develop and maintain a comprehensive list of qualified contractors to perform preventative maintenance and equipment repairs.
- Evaluate and monitor the proper function of process equipment such as glass lined reactors, scrubbers, filter dyers as well as auxiliary equipment such as temperature control modules, chillers, and inert gas systems.
- Monitor air quality, flow, and pressures within the building.
- Work with chemical operations team to coordinate facility, equipment preventative maintenance, and process equipment repairs.
- Continuously improve quality and efficiency of chemical manufacturing equipment.
- Ensure the efficient operation of building utilities, HVAC, & systems equipment.
- Work with chemical operations team to identify and implement any initiatives for continuous improvements.
- Work with chemical operations team to ensure compliance with health, safety, and environmental regulations.
- Maintain chemical process equipment P&IDs.
- Work with chemical operations team to lead any efforts for the specification and implementation of new process equipment.
What You’ll Bring:
- BS in Mechanical Engineering.
- 10+ years experience in a chemical manufacturing environment, with knowledge of contemporary methodologies of liquid and solid transfer.
- 5+ years of leadership, as well as project management experience.
- Knowledge of process chemistry equipment and techniques, and a demonstrated ability to solve highly technical problems.
- Proficiency with the use of spreadsheet and database software to compile, analyze and present data, as well as use of SolidWorks and AutoCAD.
- This position will also use equipment including hand and power tools, spark tester, welding equipment, forklift, electrical test devices, full-face respirator and self-contained breathing apparatus (SCBA) when required.
Apply Now and move your career forward with a great team and continually growing leader!
Questions? Contact Becky Hines directly at Becky@CarexEngineering.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.
#LI-BH1
Looking to take the next big step in your career with a highly successful specialty chemical manufacturer focused on Active Pharmaceutical Ingredients (APIs)? This could be the role you're looking for!
– Fulltime, direct hire Chemical Process Engineer onsite in Madison, WI
– 3+ years of experience in organic chemical synthesis, ideally in small molecules / APIs
– Compensation for this position is anticipated to start at $70,000+ annually.
What You’ll Do:
The Chemical Process Engineer will run the chemical synthesis of active pharmaceutical ingredients (APIs) within the manufacturing facility, as well as have the opportunity to help transfer it to a new building and design the process itself! This role will directly optimize chemical manufacturing processes with existing equipment to improve yields and reduce cycle time. Key responsibilities and activities include:
- Develop best practices for chemical manufacturing facility and equipment – standard operating procedures for unit operations.
- Optimize existing chemical process parameters for existing equipment.
- Transfer existing chemical manufacturing processes from existing equipment to new equipment within new facility.
- The Chemical Process Engineer will work with the manufacturing staff in the Technical Manufacturing facility to produce bulk product.
- Optimize chemical manufacturing cycle times.
- Work with chemical operators and process chemists to troubleshoot issues that may arise.
- Become the resident expert for implementation of new chemical equipment.
- Working with process chemists, author chemical manufacturing records.
- Process Safety Advocate – Continuously review processes and operations to identify potential safety issues.
- Identify and implement both equipment and process modifications to increase products yields, reduce cycle times and increase equipment productivity.
- Will be working with up to 500 gallon chemical process reactors, agitated Nutsche filter dryer and using full-face respirators and self-contained breathing apparatus (SCBA) when required.
What You’ll Bring:
- An AS or BS in Chemical Engineering.
- Strong knowledge of organic chemistry.
- 3+ years of previous experience with glass-lined chemical reactors within a chemical manufacturing environment.
- Experience working with equipment within an API facility ideal.
- Hands-on experience and knowledge of safety measures when operating within chemical synthesis spaces is required.
- Ability to understand process safety and unit operation impacts of chemistry to be executed, including for process changes.
- Ability to read and understand P&IDs, PFDs, mechanical and electrical drawings, and proficiency in processing multi-step chemical syntheses.
Apply Now and move your career forward with a great team and continually growing leader!
Questions? Contact Becky Hines directly at Becky@CarexEngineering.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.
#LI-BH1
Our Partner is hiring a IT Business Analyst. In this role, you’ll be responsible for requirements definition and documentation, translating business requests into concrete IT deliverables, process mapping and functional design.
What you’ll do:
- Works directly with business leaders to capture incoming demand and translates incoming demand into concrete IT deliverables and specific changes to the environment; works directly with Business Partners and IT Leadership in prioritizing competing requests.
- Understands benefits of requested changes and translates into hard savings to create ROI discussion.
- Documents all aspects of user, functional, and non-functional requirements.
- Works directly with Business in understanding specific areas for testing and assist end users in understanding how to write user acceptance testing documentation.
- Lead, conduct and facilitate process workshops to understand both the As-Is and To-Be Process.
- Anchor change through identifying specific activities the business needs to change to achieve the benefits of an individual request.
What you’ll bring:
- Minimum of 3 years of experience as a Business Analyst in an Information Technology Department is required.
- 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.
#LI-Hybrid
Our Partner is hiring a Senior Enterprise Architect. In this role, you will lead the development of IT roadmaps and work collaboratively with the Information Technology leadership team and key business area leaders to shape and drive future IT investments. The Senior Enterprise Architect will drive Information Architecture strategy, best practices, and data modeling as well as governance across Enterprise guiding principles.
What you’ll do:
- Understands current business processes, recognizes areas of opportunity, and develops plans to improve business processes
- Links corporate and department strategic initiatives to actionable Information Technology investment roadmaps
- Communicates value of strategies and roadmaps to IT and business leadership
- Works with business partners to develop comprehensive business cases for IT project investment
- Leads cross-functional teams to identify optimal technology solutions to solve business opportunities
- Ensures software solutions are in alignment with department and corporate policies and standards
- Drives application portfolio management for assigned functional areas, and identifies opportunities to leverage existing portfolio applications, eliminate redundancy, and reduce costs
- Evaluates new technology, and understands how it can be leveraged to improve business process
What you’ll bring:
- Minimum 10 years of experience with demonstrated success in business process analysis, and delivery of software applications.
- Background in Consumer Goods and SAP strongly preferred.
- Extensive knowledge of developing Information Technology roadmaps and plans
- Demonstrated ability to clearly communicate linkage between strategies and roadmaps
- Excellent analytical skills
- Strong business acumen in multiple business process areas desired
- Strong financial understanding of business and IT; able to assess financial implications of decisions and actions
- Excellent verbal and written communication skills
- Strong relationship management skills, including team building, relationship management, negotiating, and conflict resolution
- Ability to influence and impart knowledge to senior management
- Ability to identify emerging trends in industry and technology
- Demonstrated entrepreneurial spirit and ability to explore new possibilities and approach issues differently
#LI-WR1
Are you a Senior Scientist passionate about supporting high quality preclinical and clinical drug candidates through excellent GLP and GCP expertise? This could be the great next step you're looking for!
What You'll Do:
This position is within the Quality Assurance department and supports ongoing development programs for both preclinical and clinical drug candidates. A key function of the role involves the continued development and maintenance of quality systems supporting Good Laboratory Practices (GLP) and Good Clinical Practices (GCP). You'll have an opportunity to work with numerous internal departments, as well as help support quality oversight functions for external partners.
Key Responsibilities Include:
- Contribute to the development of a GLP quality and compliance systems to support non-clinical and clinical phase drug development
- Writing, review, change control, approval, issuance, and organization of Standard Operating Procedures (SOPs)
- Organization and control of quality, compliance, and project related documentation
- Support utilization of an electronic document management system (Veeva QualityDocs)
- Review and approval of internal and vendor generated documentation
- Perform Quality related tasks in coordination with Bioanalytical and DMPK
- Issuance, review, tracking, and completion of internal deviations, out of specifications, and CAPAs
- Auditing of vendor and internal documentation and files
- Assisting with generation, tracking, monitoring, and reporting of key quality metrics
- Maintain knowledge of current compliance expectations and regulations pertaining to GLP/GCP testing
- Collaborate with, and provide quality support for, other departments (Bioanalytical, DMPK, Project Management, Toxicology, Clinical Operations, etc.)
- Participate in meetings with vendors and external organizations as the QA team representative
What You'll Bring:
- Bachelor’s degree in a science field
- Minimum of 8 years of experience in a pharmaceutical development company and/or contract research organization (CRO)
- Working knowledge of drug GLP regulations, as well as ICH/FDA guidance documents
- Previous experience with GLP/GCP quality systems, specifically 21 CFR Part 58
- Prior experience with use of an electronic document management system in a regulated environment
- Understanding of document control requirements in a FDA regulated organization
- Competent knowledge of and ability to use Microsoft Word and Excel
- Ability for occasional business travel
- Excellent written and verbal communication skills and ability to communicate with internal and external parties
- Ability to work with diverse professionals and promote cooperation, shared understanding, and commitment to ensuring best in class quality assurance protocols
- Highly motivated team player willing to contribute to a growing pharmaceutical organization
- Ability to work independently with minimal supervision and as well as manage priorities within a fast-paced environment
- A detail-oriented self-starter who endeavors to anticipate and resolve problems and seeks opportunities to grow their role and responsibilities
Apply Now and move your career forward with a great team and rapidly growing 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.
#LI-AV1
Our partner in the biotech space is looking to add a Product Marketing Specialist to the team. You'll work in conjunction with Product Management and Product Marketing teams to provide support in development, planning, communication, execution, and monitoring worldwide marketing strategies (short and long-term) and tactics for the Life Sciences product portfolios. Assist with managing the programs and communications about the products and services to internal and external customers in assigned portfolio area(s). Work closely with branch marketing and marketing services to ensure successful adoption and execution of global marketing plans and activities.
WHAT YOU'LL DO:
- Assist with the development and implementation of cohesive go-to-market strategies and tactics for the assigned portfolio of products and services to maximize revenue growth and achieve forecast goals.
- Support coordination of Product Management, Segment Marketing, and Sales/Branch marketing efforts.
- Collaborate with Product Management, Marketing Services, and Segment Marketing to use input from customer needs and competitive landscape to create overall messaging strategy and promotional tactics to maximize product portfolio revenue.
- Provide support for tactical plans for new product introductions and legacy products which may include website refinement, e-marketing campaigns, tradeshows and events, printed literature, sales tools, press releases, and public relations to meet business objectives, deadlines, and budget.
- Assist with implementation of global 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.
- Support the development and execution of:
a. Detailed tactical plans and metrics for product launches and legacy products.
b. Marketing collateral in support of new and legacy products.
c. Campaigns / themes and support tools for trade shows and conferences.
d. Analysis of competitor commercialization activities and tactics and recommendations for strategic counter tactics.
- Working with Product Managers and Segment Marketing Managers, 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.
- Provide input on the 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 marketing efforts aligned with strategies.
- Provide 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.
- Working with product management, review and understand product portfolio marketing budgets based on the yearly planned marketing activities within assigned portfolio. Analyze expense results, trend lines, identification, and explanation of exception items. Regularly monitor tactic performance based on target metrics.
- 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 being open to incorporating our partner’s 6 Emotional & Social Intelligence (ESI) core principles in daily work.
- Understands and complies with ethical, legal and regulatory requirements applicable to our business.
MANDATORY QUALIFICATIONS:
- BS in life science field or equivalent experience
- 2 or more years’ experience in marketing life sciences products and/or services or equivalent experience
- Ability to comprehend, present, and discuss scientific content at the intermediate level
- Experience with a variety of marketing functions including 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.
- Attend industry trainings, workshops, conferences, focus groups and other activities associated with marketing tactics as a presenter or representative.
- Demonstrated effective written and verbal communication skills.
- Demonstrated ability to work on multiple detailed projects and assignments simultaneously and independently.
- Highly motivated self-starter and goal-oriented professional who can adapt style and approach to suit different audiences
- Proficient in Windows PC based environment and MS Office
PREFERRED QUALIFICATIONS:
- PhD or equivalent research and laboratory experience.
- Experience working in a global organization with regional branch and/or distributor marketing and sales team.
- Experience or familiarity with sales strategies and techniques
PHYSICAL DEMANDS:
- Ability to move objects up to 25 pounds.
- Ability to use computer and telecommunications equipment including Microsoft Office applications.
- Ability to travel as needed, domestic and international, up to 30% of the time.
This position has a target salary range of $67,000 to $90,000
#LI-AV1
Do you have strong Regulatory experience in pharmaceutical drug development and a passion for mental health treatment? This could be the perfect leadership role in the next step of your career!
What You'll Do:
The Director, Regulatory Affairs is responsible for the strategic planning, direction and coordination of regulatory activities to support the company's leading drug development programs. This individual will be the key leader in providing expertise to ensure compliance with federal and state regulations across all functional areas of drug development. In addition to a strong knowledge of FDA regulations and submissions, as well as significant experience working with global regulatory agencies, key responsibilities of the role include:
Apply strategic knowledge to small molecule drug development across all stages of a product’s lifecycle (pre-IND through post-licensure) and across functional disciplines (e.g., clinical, nonclinical pharmacology/toxicology, clinical pharmacology, CMC).
- Skillfully lead communications with FDA and other global regulatory agencies (e.g., formal meetings, emails, etc.) to facilitate review and approval of submissions (including INDs and NDAs).
- Develop, review, submit and follow all regulatory agency submission materials (e.g., initial IND applications, annual reports, clinical study reports, protocols, and amendments, MedWatch reports, etc.).
- Proactively identify and address regulatory compliance issues. Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Lead, develop, and implement CMC regulatory strategies to ensure on-time and high-quality submissions for Drug Master Files (DMFs), marketing applications (NDA/ANDA), and post-approval lifecycle submissions. Serve as main contact with regulatory agencies (e.g., FDA, DEA, EMA health authorities, state authorities, etc.) when needed for drug product development.
- Manage a team of regulatory affairs staff to ensure the team delivers consistent and high-quality work products in a timely manner.
- Communicate regulatory information to team members, partners, and other stakeholders and ensure that the information is interpreted and relayed correctly.
- Attend meetings and engage with designated working teams and provide regulatory input and guidance to project teams, including quality control practices.
- Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Act with kindness, curiosity, and respect for others.
- Understands and complies with ethical, legal, and regulatory requirements applicable to our business.
What You'll Bring:
- Bachelor’s degree required, preferably in Regulatory Science or a health sciences field. Master's Degree ideal.
- A minimum of fifteen years of experience in the pharmaceutical industry (small molecule) or a related area. (Proven 5 years in a senior leadership role with strong management skills).
- Strong scientific or clinical research background required.
- Demonstrated knowledge of regulatory affairs, such as 21 CFR 210/211/310/312/314, FDA guidance documents, and ICH guidelines for both development projects and commercial projects, with evidence of successful submissions to FDA, EMA, MHRA, or other health authorities
- Demonstrated track record of preparing original INDs, NDAs, and amendments in compliance with applicable FDA regulations.
- Demonstrated CMC regulatory experience with drug substance and/or drug product and API production.
- Familiar with a variety of the field's concepts, practices, and procedures, including FDA guidance documents and ICH guidelines and GCP.
- Ability to work in a cross-functional team environment with dynamic timelines and priorities.
- Experience with DEA-regulated substances and clinical trials.
- Strong knowledge of eCTD elements and format and submissions process and procedures.
- Critical thinking/problem-solving, writing, oral communication and organizing skills and presentation skills.
- Experience working with all levels of management and key business stakeholders.
- Familiarity or experience with regulations related to controlled substances is ideal, but not required.
Apply Now and move your career forward with a great team and non-profit leader in mental health!
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.
#LI-AV1
Our partner, a highly successful specialty chemical manufacturer, has an opportunity for a motivated individual to join their talented marketing team in Madison, WI as an Associate Product Marketing Manager. They set the standards for innovation and quality products in their industry. The Associate Product Manager will assist with the execution and implementation of all marketing related activities for the domestic team. This person will also assist the sales team in preparing for tradeshows and customer sales meetings. This position will require extensive interaction with most functional areas throughout the organization and must be able to foster productive working relationships.
What you’ll do:
New Product and Packaging Development:
- Drive product execution process for all confirmed new product initiatives from approval to launch. Work with key functional areas as necessary to complete the following… confirmation of package sizes, establishment of product codes and part numbers, release, and distribution of product ECO’s and updates of price lists and packaging development.
- Work with registrations to ensure package labeling meets requirements.
- Drive the development and execution of packaging.
- Proactively work with purchasing to help ensure efficient, responsible, cost-effective packaging development and transition plans for both existing and new products.
Sales Collateral Development:
- Work with sales team to develop collateral materials as necessary. This includes working with graphic artists, sales managers and outside customers to ensure successful completion.
- Assist and/or initiate collateral development for all new product introductions as well as updates and enhancements to existing collateral materials, including coordination and distribution of price list updates.
- Monitor inventory levels and (in concert with purchasing or Dunlop) determine economic order quantities of new materials as necessary.
- Attend all divisional sales meetings and relevant customer meetings.
Promotional Planning and Support:
- In concert with the Director of Marketing and Sales team, develop and implement promotional marketing programs that support sales objectives.
- Coordinate, and co-develop, vet, and execute advertising campaigns that support new product introductions, product initiatives and other objectives.
- Work with Director of Marketing and Sales managers to develop and execute promotional materials for customer specific initiatives.
- Assist in the creation and development of trade show promotional materials and displays, and related materials.
Product Stewardship:
- Actively work with materials management and accounting to identify products that no longer meet required performance criteria.
- Evaluate product performance and manage product life cycle to drive continued sales growth through merchandising, promotional or packaging solutions.
Website and Digital Content:
- Work with Director of Marketing & Associate Marketing Manager to manage websites and execute digital communications (e.g. – eblasts, online promotional contents).
What you’ll bring:
- Bachelor’s degree in marketing or business administration
- Minimum 3-5 years of related experience, ideally in a manufacturing environment. Previous experience as associate product manager preferred.
- Requires strong verbal and written communication skills as well as superior spreadsheet and database management capabilities.
- Must be comfortable with and have experience interacting with cross-functional areas/teams.
- Experience and ease in delivering marketing/sales related presentations to a live audience is required.
- Must be able to assess divergent categories of information and formulate actionable plans.
- Adaptability is a must.
- Must also be adept at MS Word and PowerPoint.
#LI-Onsite
Our Partner is hiring a Senior Statistical Programmer. We are seeking an exceptional individual with strong statistical programming and analytical skills to participate in the development, validation, and post-marketing support of genomic biomarker assays that help cancer patients and their physicians make better treatment decisions. As a member of the clinical biostatistics team, the Senior Statistical Programmer will perform statistical analysis on data from diverse sources, using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, and SAS/ODS to create and maintain tables, listings, and graphs. This position will create analysis datasets in a standard format following specifications or per study needs, and assesses the quality of data analysis programs, as needed. The Senior Statistical Programmer will create innovative data visualizations and generate dashboards using creative techniques in either SAS, R, or Power BI per study needs. In addition, this role will collaborate closely with clinical biostatistics, clinical data operations, clinical development, clinical operations, medical communications, and medical affairs to provide expertise in the generation of statistical analyses and reports.
What you’ll do:
- Perform data analysis using primarily the SAS programming language for the summary and interpretation of medical and clinical data.
- Ensure accurate and timely completion of the statistical programming activities for assigned projects; including, but not limited to, exploratory and formal data analyses for final study reports, abstracts, posters, manuscripts, and ad-hoc projects, including verification and documentation of results.
- Participate in the review of analysis plans and development of programming requirements, as needed.
- Work on complex problems and exercise independent judgment in the selection and adaption of methods appropriate for the specific objective, as needed.
- Independently verify other programmer’s results.
- Directly support project biostatistician, requiring minimal guidance.
- Proactively identify and resolve or escalate issues that could impact the quality or timely completion of a deliverable.
- Apply ability to write, test, and validate SAS programs, and review resulting output and data.
- Ability to program defensively, check results, and consistently produce accurate output.
- Ability to work on multiple projects and prioritize tasks to meet project needs.
- Ability to generate innovative data visualizations.
- Interact cross-functionally with biostatisticians and other members of the clinical team to perform ad-hoc analysis and generate reports necessary according to the team and study requirements.
What you’ll bring:
- Bachelor’s Degree in Computational or Biological Sciences, or related field as outlined in the essential duties.
- 5+ years of relevant experience in academia, pharmaceutical, or medical device industry.
- Demonstrated ability to support highly visible statistical programming projects of clinical data within a fast-paced environment.
- Demonstrated working knowledge of statistical theory and statistical programming techniques and procedures; including, but not limited to, SAS.
- Demonstrated working knowledge of a wide application of technical principles, theories, concepts, and techniques.
Are you a Senior Consultant with a depth of experience in standing up Systems Engineering functional areas within physical product companies? This Senior Systems Engineer consulting role could be exactly what you're looking for in your career!
*Position is hybrid with onsite work and collaboration at the HQ in Madison, WI.
*Sponsorship is not available with the position.
**Carex-sponsored health insurance coverage provided for all full-time consultants.**
What You'll Do:
In this role you will be responsible for standing up a new Systems Engineering functional area within the Product Design Engineering team of a worldwide leader in luxury technical products. As a Senior Systems Engineer Consultant, you will be working in a collaborative environment on a high-visibility project while you develop and share a playbook of solutions and best practices that moves the Product Design Engineering team forward. In this role you'll be able to make an impact including:
Key Responsibilities:
- Develop, document, and train Engineering staff on Systems Engineering processes and best practices, including:
- Requirements elicitation, documentation, and review within a requirements management database.
- Manage transformation of customer needs into design requirements, especially for physical products.
- Manage traceability of requirements to verification and validation tests.
What You'll Bring:
- Minimum of a BS in Systems Engineering or similar degree.
- At least 10 years of experience in Systems Engineering, with at least 5 years of solid, first-hand experience in standing up new functional areas.
- Deep experience in implementing and managing Systems Engineering processes at companies that design and engineer products with both physical and software elements.
- A background or experience in Aerospace or Medical Devices is highly desired, though similar highly-technical and regulated environments also considered.
- Proven track record and playbook for implementing Systems Engineering processes.
- Experience with, and knowledge of, industry standards such as the Systems Engineering Body of Knowledge (SEBoK).
- Systems Engineering Professional Certifications: INCOSE Expert Systems Engineering Professional (ESEP) preferred.
Take the next big step in your career and Apply Now!
Questions? Contact Becky Hines directly at: Becky@CarexEngineering.com
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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Our Partner is hiring an SAP Security, Security Operations and Security Business Analyst.
What you’ll do:
- Facilitate group meetings, workshop sessions and requirements gathering, for both functional and technical security requirements
- Draft security related processes, workflows, integrations, and access controls
What you’ll bring:
- Demonstrated experience with operationalizing the execution of ITGCs related to financially significant systems
- Experience with SoX, and NIST key controls
- Experience in identifying process gaps around newly introduced application(s)/tool(s) and converting those gaps into solutions by working those into security operational processes
- Experience in creating security related in-depth process mapping with workflows and formal documentation depicting and capturing every relevant technical detail
- Strong knowledge of workflow design around access provisioning, IAM & Azure AD integration and other security tasks performed for any of the applications managed by Tech Security and Security Operations for requests coming through Service Now intake form
- Experience in SAP technologies and modules such as BTP, MDG, IBP, ECC, SAP GRC, PI/PO, and Hana DB
Are you well-versed in quality control and analytical methods within small molecule production? Looking to find an exciting 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 will play a cornerstone role in the development, characterization, validation, and implementation of analytical methods for the manufacture of both new and current products that are used in life science research and medical devices, as well as Active Pharmaceutical Agents (API) in a brand new CMC facility. Some of the key responsibilities include:
Perform analytical method validation and characterization when required to support process improvement, product transfer, or new product realization projects.
Be able to independently perform all aspects of method development and method validation; product and raw material testing are also a function of this position.
Develop reports, protocols, and SOPs for new and current analytical methods.
Mentor and train junior scientists and aid when needed in high throughput times of intermediate testing, final product and raw materials.
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.
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.
Perform laboratory investigations for Out of Specification results or other testing abnormality. Investigate complaints from customers and internal deviations/nonconformances as assigned.
Develop and maintain a product / intermediate stability program.
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.
Write, review and revise, as necessary, Inspection Plans, test methods, SOPs and other QC Dept procedures, for accurate and complete content and ensuring they meet documentation policy.
Provide training on QC methods and instrumentation in the laboratory as needed.
Understand and comply with ethical, legal and regulatory requirements applicable to the business.
What You'll Bring:
Degree in Chemistry or related Lab Science: Master's with 2-4 years of experience, or a Bachelor's with 4-7 years of direct experience in a Quality Control lab using advanced equipment and techniques.
Extensive experience in Method Validation.
High level of knowledge on the use and troubleshooting of typical analytical instruments, including GC, ICP-OES, LC-MS, HPLC, NMR, Extinction Coefficients and Karl Fisher.
Working knowledge of, and the ability to independently determine, solubility, viscosity, TGA Fluorescence, mass and conductivity.
Knowledge of basic descriptive statistics such as mean, standard deviation, confidence intervals and linear regression, including experience with the use of statistical tools to analyze data.
Proven track record in the design of new and existing product method development.
PREFERRED BUT NOT REQUIRED QUALIFICATIONS:
MS with 5-7 years of experience in method development and validation using HPLC, Mass Spectrometer, LC-MS, NMR, ICP-OES, GC, NMR, Spectrophotometers or Luminometers.
Experience or familiarity with ISO9001 requirements.
Independent, self-starter with proven results in problem identification, planning, communication and project management.
Desire for future growth into QC Department Leader / Supervisor.
Organizational and multi-tasking skills; able to manage several tasks simultaneously.
This position includes physical demands such as working with chemical reagents required for analytical testing, having the ability to identify and distinguish colors used in testing, wearing and using personal protective equipment, and traveling as needed.
The annual base compensation range for this position is anticipated to be between $70,000 – $100,000 per year.
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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Are you looking to join an explosive start-up focused on Drug Discovery and helping creating new Therapeutics? If you have a Proteomics background and expertise in Mass Spectrometry, this could be the role you're looking for – join a mission to accelerate the drug discovery of lifesaving therapeutics!
What You’ll Do
In this Scientist or Senior Scientist role, you'll be able to make an impact on day one. This is 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. Individuals within this role will be able to:
- Develop and optimize HDX, HRF, XL-MS experiments (and others as described) for applications including:
- Epitope Mapping
- Protein-Protein and Protein-Small Molecule Interactions
- Structural Analysis
- Visualize complex Proteomics datasets
- Design and Setup the lab and lab instruments as needed
- Provide technical presentations to clients and at conferences
- Manager Customer projects
- Author scientific papers
- Write grant funding proposals
- *This role includes future potential to manage a team of analytical and biological chemists
What You’ll Bring
There are 2 positions available, with flexibility in both degree and experience needed:
- Minimum of BS degree and 3-4 years of industry experience, or a Masters degree with 2+ years of industry experience for a Scientist-level role.
- Wet lab experience is required
- Mass Spectrometry sample preparation experience is preferred, but not required
- Minimum 4+ years of experience and strong expertise in LC-MS protein analysis for Senior roles
- 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 Preferred Qualifications
- Experience or an understanding of the following techniques
- Hydrogen/Deuterium Exchange (HDX):
- Hydroxyl radical protein footprinting (HRF)
- Chemical cross-linking mass spectrometry (XL-MS)
- Site-specific labeling MS
- Glycoprotein analysis with MS
- In-silico structural modeling
- Protein expression and purification
- Membrane protein expression and purification
- Mutagenesis
- SEC-MALS
- ELISA
- Protein-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
This position is based in Madison, WI and includes a full relocation package for applicable candidates. Excellent compensation package includes salary anticipated to be between $50,000 – $120,000+ dependent upon degree and experience, benefits package, stock options and performance bonuses (both cash and stock options).
If you’re looking to fully use your expertise and get on the ground floor of an exciting start-up, Apply Today!
Questions? Email Andie Dumond directly at andie@carexscientific.com
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
We are seeking a mid-level software developer on behalf of our partner, a leading financial services provider, to join their Lending Product team. The ideal candidate should have strong technical skills, be customer and team-focused, drive results, and be passionate about learning and helping team members grow. This role is a year-long Contract to Hire position that is not eligible to provide sponsorship.
The Lending Product Team, which includes the Insurance Design and Services team as well as the Billing and Reporting team, supports and enables processes for the lending products provided to customers and their members. The systems supported by the Lending Product team enable group level policy administration, member level policy administration, and premium and refund processing.
Responsibilities:
- Develop, test, and document high-quality business systems solutions in a business environment
- Understand and advocate for programming best practices
- Work effectively as a team member in a business or academic environment
- Problem-solve, analyze issues, and think creatively
- Provide a high level of customer service
- Communicate technical concepts to both technical and non-technical audiences
- Influence others and demonstrate the ability to learn upcoming technologies
- Show strong leadership and mentoring skills that drive the growth and development of team members
- Embody an agile and DevOps mindset with a strong focus on delivery
Requirements:
- Around 5 years of relevant work experience
- Bachelor’s Degree in Computer Science or equivalent combination of education and experience
- Knowledge of modern programming best practices for the Microsoft technology stack, such as .NET, C#
- Knowledge of API development, testing automation, and application design strategies
- Experience in developing and using Web Services
- Knowledge of Azure Cloud development, including setting up and maintaining pipelines, using Azure Kubernetes Services, and Function Apps
- Experience working with data, including SQL Server or Azure SQL
Preferred Skills:
- Experience using CI/CD and automation
- Front-end/UI skills (React, Typescript, Single-page Application preferred)
- Experience using Azure Data Factory
- Experience building reports using Power BI
- Knowledge of SSIS, SSRS
#LI-AM1
Our mission driven healthtech partner is looking to add Senior Customer Success Managers to their team in Madison, WI. Candidates should have knowledge of the healthcare sector, have strong project management and SaaS implementation experience and take a proactive, customer-centric approach! This role is a hybrid role out of the Madison office.
The Customer Success team is an integral part of fulfilling this mission: this team builds new opportunities and solve challenges for our customers as they help people find and connect with the help they need. The customers are innovative organizations across many sectors — healthcare, government, local and national nonprofits, and private consultancies, to name a few. The Sr Customer Success Manager role will center around building lasting customer relationships, onboarding new customers, and growing customer accounts, our impact, and our company. The ideal candidate has 5+ years experience in account management, customer success, project management, with a significant experience managing large enterprise accounts for healthcare or health plan organizations. If this sounds like you, apply today!
What You'll Do:
- Proactively engage clients to drive product adoption and optimal product experiences
- Develop & maintain relationships with key customer champions including Executive Sponsor, Project Manager and Technical Lead, to name a few
- Manage client and project communications- be a leader driving the project plan and sharing best practices of how your customers can mobilize the functionality
- Track customer usage metrics and respond to any customer deployment or product issues
- Create and deliver Executive Business Reviews on a quarterly cadence
- Take ownership of technical issues, responding in a timely manner, and working with cross-functional teams to document problem resolution steps
- Manage escalations and expectations for both the client and internal personnel
- Take ownership of the entire onboarding process for each client
- Facilitate a smooth hand-over from sales to service
- Create and manage the scope and timeline of rollout, alongside customer expectations
- Train customer’s staff and relevant partners on how to use the suite of tools
- Create and share materials to support internal and external marketing
- Advocate for the customer, champion their success, drive renewals and expansions
- Drive usage throughout customer organizations including growing usage across teams, departments as well as the adoption of product features to achieve the customer’s goals
- Collaborating with the Customer Success team to build a thriving department and foster the overall success of the company and the people we serve
- Advocating for the ongoing needs and goals of the customer internally – gathering feedback from customers and understanding both how to meet them where they are and also how to help get them where they want to go
What You'll Bring:
- Possess a strong desire to use your job and mind to make the world a better place for people in need
- BS/BA degree or equivalent
- 5+ years experience in account management, customer success, project management, with a significant experience managing large enterprise accounts for healthcare or health plan organizations
- Experience with technology and able to learn new technologies quickly; direct experience with SaaS application support requirements
- Customer-focused, enthusiastic, positive, and service-oriented
- Experience with social determinants of health and healthcare Interest in organizational innovation, social enterprise, community organizations, and governmental groups
- Ability to prioritize, multi-task, and perform effectively under pressure
- Skilled at problem-solving, decision making, negotiations, and ability to navigate challenging situations in a professional manner
- Superior communications skills (presentation, written, and verbal) and demonstrated ability to communicate/present effectively at all levels of the organization including the C-suite
- Ability to travel to some customer locations
#LI-JK1
#LI-Onsite
Our partner is seeking a contingent IT Help Desk Analyst to join their team, providing first-tier escalation support for Help Desk calls. The ideal candidate will be responsible for responding to requests and incidents, implementing solutions, and ensuring a first-call resolution for end users when possible.
What You'll Do:
- Assist end users by providing a mix of technical and customer service skills, handling repeatable documented troubleshooting tasks.
- Provide technical assistance and support for general and routine incoming queries related to End User devices, VPN connections, and user access management.
- Perform remote software distribution via an endpoint management tool and coordinate with users for successful distribution.
- Assist and troubleshoot corporate and personal mobile devices.
- Manage incidents and requests, including escalation and assignment to appropriate support teams.
- Create and manage Master incidents in ServiceNow for IT Rapid Response Teams and Cybersecurity Incident Response teams.
- Write, review, and maintain articles in ServiceNow knowledge base database.
- Provide in-person and remote technical support for non-IT business functions.
- Assist with new team member onboarding and training, and create training documentation as necessary.
- Work securely using two-factor authentication and other security measures as required.
- Participate in a 24/7 on-call rotation.
- Communicate user tasks and stories clearly to all stakeholders.
What You'll Bring:
- Associate Degree in Information Technology (preferred) or relevant IT certifications.
- Experience with Microsoft Windows operating systems, software, client and mobile computing hardware, peripherals, and general End User device troubleshooting.
- Strong knowledge of Incident and Request management using ServiceNow (preferred).
- Familiarity with Office 365 and Ivanti’s Endpoint Manager (formerly Landesk).
- Ability to work individually and as a team member.
- Ability to manage time effectively and work in a high-paced environment.
- Demonstrated effective interpersonal, verbal, and written communication skills.
- Ability to communicate professionally with End Users in problem/urgent situations.
- Demonstrated ability to apply logical reasoning to situations and derive workable solutions to low complexity problems.
- Ability to plan and carry out responsibilities with minimum direction and work effectively when multiple priorities exist.
- Ability to work effectively in a diverse work environment.
If you are a dedicated IT professional with a passion for problem-solving and customer service, we encourage you to apply for this position.
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