Analytical Development Scientist
About The Position
At MilliporeSigma in Miamisburg, we are seeking a highly skilled Analytical Development Scientist to join our Process & Analytical Development team within the Life Sciences division. In this role, you will play a key part in developing analytical methods for new and existing stable isotope-containing compounds, many of which are or will be used to evaluate Active Pharmaceutical Products. Act as the Subject Matter Expert, develop and validate analytical methods . Review development options broadly and propose development activities, execute those activities, validate, document, and transfer those options the Quality Control team. Provide support for improving current methods as needed. Work cross-functionally with other Analytical Development team members, R&D, Process Development, Production, QC, QA, Regulatory, and Program Management. Align your work with industry best practices and regulatory requirements. Support the site for the company's center for stable isotope product development and production of products used in research, industry, government, and as active pharmaceuticals.
Requirements
- Bachelor’s Degree in a scientific discipline (e.g., Analytical Chemistry, Chemistry, Biology, Biochemistry, etc.)
- 2+ years of industry experience with chromatography methods including HPLC and Mass Spec.
- 1+ years of experience with and execution of analytical method development, including evaluation of options, scouting, selection of optimal methods, and execution of method validation.
Nice To Haves
- Master’s Degree in a scientific discipline (e.g., Analytical Chemistry, Chemistry, Biology, Biochemistry, etc.)
- Excellent collaborator and communicator with other analytical scientists, synthetic chemists, QA, and regulatory.
- Understanding of regulatory requirements required for analytical methods from early development through validation.
- Ability to apply nuanced approaches to address varying levels of needs.
- Experience with current instrument platforms from industry vendors.
- Experience and understanding of a wide array of analytical methods, including GC, NMR, wet chemistry methods.
- Experience with evaluation of stable isotope containing small molecules.
Responsibilities
- Act as the Subject Matter Expert, develop and validate analytical methods
- Review development options broadly and propose development activities, execute those activities, validate, document, and transfer those options the Quality Control team.
- Provide support for improving current methods as needed.
- Work cross-functionally with other Analytical Development team members, R&D, Process Development, Production, QC, QA, Regulatory, and Program Management.
- Align your work with industry best practices and regulatory requirements.
- Support the site for the company's center for stable isotope product development and production of products used in research, industry, government, and as active pharmaceuticals.
Benefits
- Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
