Stability Chemist III

2 days ago

Minnesota City, United States Actalent Full time
Job DescriptionJob DescriptionJob Title: Stability Chemist III
Job Description

The Kidney Care R&D - Stability team supports R&D projects for new and existing products. We currently have an opening for a Research Associate III to represent Kidney Care Solutions as a Stability Subject Matter Expert. The successful candidate will apply sound chemistry and stability planning expertise to identify and resolve stability indicating characteristics. The effective integration of chemistry and stability enables establishment of shelf life for new or existing products manufactured for rapidly growing markets and allows for the qualification of product changes on a global scale. The Stability Subject Matter Expert will design strategies and make recommendations that are non-routine to address technical, regulatory, and business requirements.Responsibilities include:- Represent R&D–Stability on project teams as a key member of the project teams’ goals and success.- Collaborate with vital team members (e.g., Product Design Owners, Project Managers, Regulatory Affairs, Quality) to anticipate business needs and gain alignment.- Craft and implement stability strategy plans for new product development and sustaining projects.- Design GMP stability studies used to establish expiration dating for product development.- Contribute to the development of technical justifications for expiration dating for new or modified products and the defense of expiration dating recommendation to key business partners.- Provide valuable input to stability assessments and requirements for new products and/or current product changes.- Partner with manufacturing facilities, analytical chemistry teams, and stability testing labs to ensure the right methods and specifications are available for stability, compatibility, and release testing. Ensure that the methods are appropriate for the product design over shelf life.- Identify risks, issues, and opportunities for improvement of existing methods, technologies, and approaches. Provide sound scientific rationale.- Author, review, and verify technical data, protocols, and reports.- Act as study director for stability projects under guidance of senior Stability team members.- Perform stability study administration activities on LIMS including study building and review, identification of product test data requiring modification, and data entry.- Develop new and/or optimize existing processes and procedures to enhance stability related practices.- Participate in investigations that correspond to atypical or out-of-specification/out-of-trend test results. Review data and author technical evaluations that characterize the stability trending of suspect data.- Leverage critical thinking to drive the investigation to conclusions based on sound scientific principles.- Successfully plan, coordinate, and lead all aspects of the progress of multiple Stability related projects, budgets, and activities working with global teams and CROs as applicable.- Contribute to and/or take lead author role for stability sections intended for submission to regulatory authorities. Use computerized systems to retrieve, evaluate, and summarize data for reporting.- Contribute to efforts beyond own scope of responsibilities to ensure project landmarks are met.

Hard Skills
  • Analytical Chemistry R&D (5+ years)
  • Method Development and Validation
  • Risk Assessment
  • Regulatory Standards
  • Stability Experience in R&D (5+ years)
  • Experience in a regulated environment (Medical Device or Pharmaceutical-FDA, 3-5 years)
  • Global Collaboration Internally (1 year)
Soft Skills
  • Critical Thinking
  • Collaboration
  • Leadership
  • Communication
  • Problem Solving
  • Project Management
Job Type

This is a permanent position.

Work Site

This is a hybrid position requiring some days on-site in NA, Minnesota and some days remote.

Work Environment

Flexible workplace policy which includes a minimum of 3 days a week onsite. Desk based role, individual contributor. Not working in the lab at all.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

  • Hiring diverse talent
  • Maintaining an inclusive environment through persistent self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

  • Stability Chemist III

    2 days ago

    Minnesota City, Minnesota, United States Actalent Full time

    Job Title: Stability Chemist IIIThe Kidney Care R&D - Stability team is seeking a highly skilled Stability Chemist III to support R&D projects for new and existing products. As a key member of the project teams, you will apply sound chemistry and stability planning expertise to identify and resolve stability indicating characteristics.Key...

  • Stability Chemist III

    1 day ago

    Minnesota City, Minnesota, United States Actalent Full time

    Job SummaryWe are seeking a highly skilled Stability Chemist III to join our Kidney Care R&D - Stability team. As a key member of our project teams, you will apply sound chemistry and stability planning expertise to identify and resolve stability indicating characteristics. Your effective integration of chemistry and stability will enable the establishment...

  • Senior Stability Chemist

    9 hours ago

    Minnesota City, Minnesota, United States Actalent Full time

    Job SummaryWe are seeking a highly skilled Senior Stability Chemist to join our team at Actalent. As a key member of our R&D - Stability team, you will play a critical role in supporting projects for new and existing products. Your expertise in stability planning and chemistry will enable you to identify and resolve stability indicating characteristics,...

  • Laboratory Chemist III

    23 hours ago

    Jersey City, New Jersey, United States EMSL Analytical Full time

    Job Title: Laboratory Chemist IIIEMSL Analytical is seeking a highly skilled Laboratory Chemist III to join our team in Cinnaminson, NJ.Responsibilities:Prepare and analyze samples to measure chemical and physical properties in various matrices.Familiarity with EPA, NIOSH, OSHA, ASTM, USP, and AOAC methodologies.Understanding of ISO 17025 and NELAC...

  • Chemist - III (Senior)

    3 weeks ago

    Spring City, United States On-Board Companies Full time

    On-Board Services is hiring a Chemist III in Spring House, PA! For immediate consideration please send your resume to resumes@onboardusa.com Subject Line: Position Title and State you are Located About Us: On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees....

  • Environmental Field Chemist

    3 weeks ago

    Kansas City, United States TRADEBE Full time

    The OpportunityTradebe is looking for a field chemist who will be responsible for identifying, packaging and labeling of hazardous waste for transportation and disposal. The ideal candidate will have knowledge in chemical classification and have interest in growing in the environmental services industry.Key ResponsibilitiesProper classification,...

  • Environmental Field Chemist

    3 weeks ago

    Kansas City, United States TRADEBE Full time

    The OpportunityTradebe is looking for a field chemist who will be responsible for identifying, packaging and labeling of hazardous waste for transportation and disposal. The ideal candidate will have knowledge in chemical classification and have interest in growing in the environmental services industry.Key ResponsibilitiesProper classification,...

  • Environmental Field Chemist

    3 weeks ago

    Kansas City, United States TRADEBE Full time

    The OpportunityTradebe is looking for a field chemist who will be responsible for identifying, packaging and labeling of hazardous waste for transportation and disposal. The ideal candidate will have knowledge in chemical classification and have interest in growing in the environmental services industry.Key ResponsibilitiesProper classification,...

  • Chemist II

    3 weeks ago

    Kansas City, Kansas, United States DeLaval Full time

    Job Title: Chemist IIDeLaval, a global leader in formulated sanitizers and topical disinfectants, is seeking a Chemist II to support the development of cleaners and sanitizers for dairy farm and food processing industries. As a Chemist II, you will have the opportunity to work on projects from concept to commercialization, collaborating with a global team to...

  • Chemist II

    1 day ago

    Kansas City, Kansas, United States DeLaval Full time

    Job Title: Chemist IIDeLaval, a global leader in dairy farm and food processing solutions, is seeking a Chemist II to join our team of experts in developing innovative cleaners and sanitizers.Job SummaryThe Chemist II will assist in the development of new and improved products, focusing on formulation, chemical properties testing, in vitro application...

  • Chemist II

    2 days ago

    Kansas City, Kansas, United States DeLaval Full time

    Job Title: Chemist IIDeLaval, a leading global supplier of formulated sanitizers and topical disinfectants and detergents, is seeking a highly skilled Chemist II to support the development of cleaners and sanitizers for dairy farm and food processing industries.Job SummaryThe Chemist II will assist in the development of new and improved products, and help...

  • Senior Chemist

    16 hours ago

    Spring City, Pennsylvania, United States On-Board Companies Full time

    About the RoleWe are seeking a highly skilled Chemist III to join our team at On-Board Companies. As a key member of our Analytical Sciences laboratory, you will be responsible for performing analytical testing of drug products and APIs under the supervision of a senior scientist.Key ResponsibilitiesConduct analytical testing (e.g., HPLC/UPLC and...

  • Chemist II

    3 weeks ago

    Kansas City, United States DeLaval Full time

    DeLaval a global supplier of formulated sanitizers and topical disinfectants and detergents is seeking a Chemist II to support our development of cleaners and sanitizers for dairy farm and food processing industries. DeLaval is developing products for global market and offers opportunities to interact with people worldwide. BASIC FUNCTION The Chemist II,...

  • Metrology Research Chemist

    11 hours ago

    Arizona City, Arizona, United States FUJIFILM Corporation Full time

    Job Title: Metrology R&D ChemistFUJIFILM Electronic Materials, U.S.A., Inc. is seeking a highly skilled Metrology R&D Chemist to join our team in Mesa, Arizona.About the RoleThe successful candidate will be responsible for developing and validating new analytical methods for the evaluation and characterization of finished products, raw materials, and...

  • Metrology R&D Chemist

    2 weeks ago

    Arizona City, Arizona, United States FUJIFILM Corporation Full time

    Job Title: Metrology R&D ChemistFUJIFILM Electronic Materials, U.S.A., Inc. is seeking a highly skilled Metrology R&D Chemist to join our team in Mesa, Arizona.About the RoleThe successful candidate will be responsible for developing and validating new analytical methods for the evaluation and characterization of finished product, raw materials, and...

  • Quality Control Chemist II

    4 weeks ago

    Charles City, Iowa, United States Cambrex Full time

    Job SummaryWe are seeking a highly skilled Quality Control Chemist II to join our team at Cambrex. As a key member of our laboratory team, you will be responsible for ensuring the quality of our products and adhering to regulatory requirements.Key ResponsibilitiesAdhere to all relevant regulations, including EPA, FDA, cGMP, and DEA, as well as internal...

  • Metrology Research Chemist

    2 days ago

    Arizona City, Arizona, United States FUJIFILM Corporation Full time

    Job Title: Metrology R&D ChemistWe are seeking a highly skilled Metrology R&D Chemist to join our team at FUJIFILM Electronic Materials, U.S.A., Inc. in Mesa, Arizona.About the RoleThe successful candidate will be responsible for developing and validating new analytical methods for the evaluation and characterization of finished products, raw materials, and...

  • Quality Control Chemist

    1 day ago

    Charles City, Iowa, United States Cambrex High Point Full time

    About UsCambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle.With over 40 years of experience and a growing team of over 2,000 professionals, we serve global clients with a strong commitment to quality and safety.About the...

  • Quality Control Chemist I

    1 month ago

    Charles City, United States Cambrex Full time

    Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients. Cambrex is a...

  • Quality Control Chemist II

    1 day ago

    Charles City, Iowa, United States Cambrex High Point Full time

    About UsCambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle.With over 40 years of experience and a growing team of over 2,000 professionals, we strive to build a culture where all colleagues have the opportunity to engage in...