Sr. Scientist - Pharmacopoeia
Thermo Fisher Scientific
Summary
Serve as a technical subject matter expert for compendial analytical methods, including methods defined in the United States Pharmacopeia (USP), European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP), Chinese Pharmacopoeia (ChP) and other applicable global compendia and testing guidance.
Job description
Evaluate the impact of pharmacopeial revisions, updated monographs, and revised general chapters on analytical methods, product specifications, and testing strategies.
Develop compendial method verification and transfer strategies, acceptance criteria, testing plans and technical documentation to support successful implementation at internal and external partners.
Initiate, author, assess, and implement analytical change controls in the applicable QMS, including impact assessments, risk assessments, and implementation plans.
Support investigations involving atypical results, out-of-specification results, deviations, method-performance trends, and laboratory events associated with compendial testing.
Requirements
- Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
- Sr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years') OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years') OR PhD
- Deep knowledge of major pharmacopeial standards, including USP, EP, JP, ChP and other applicable global pharmacopeial requirements
- Experience interpreting pharmacopeial monographs, general chapters, and compendial requirements to support testing strategies, specifications, and product release
- Experience evaluating, planning, executing, and documenting the verification and/or transfer of compendial methods to Quality Control laboratories, manufacturing sites, and/or contract testing laboratories
- Experience initiating, authoring, assessing, and implementing analytical method-related change controls within an electronic or paper-based QMS
- Strong technical writing and communication skills, including the ability to author protocols, reports, technical assessments, method procedures, and change-control documentation
- Must be legally authorized to work in the United States without sponsorship
Benefits
- Medical plan
- Dental plan
- Vision plan
- Health incentive programs
- Employee assistance program
- Family support programs
- Commuter benefits
- Tuition reimbursement
- Paid time off
- Paid holidays
- Paid parental leave
- Accident insurance
- Life insurance
- Short-term disability
- Long-term disability
- 401(k) retirement savings plan
- Employee stock purchase plan
Company overview
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. The company's mission is to enable customers to make the world healthier, cleaner, and safer. With over 100,000 employees globally, Thermo Fisher provides an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through its industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. The company serves customers across healthcare, life sciences, applied markets, and pharmaceutical sectors, offering solutions that accelerate research, solve complex analytical challenges, improve patient diagnostics, and increase laboratory productivity. Headquartered in Waltham, Massachusetts, Thermo Fisher operates globally, delivering critical scientific products, services, and workflow solutions that support researchers, organizations, and companies in addressing some of the world's most pressing issues.