Role Summary
- Analytical scientist providing scientific leadership in development of advanced analytical methods to support biotherapeutic protein characterization, process understanding, and product development; serves as analytical lead and has supervisory responsibilities.
Responsibilities
- Independently develop capillary electrophoresis and chromatographic methods to characterize biotherapeutic proteins, variants, and impurities.
- Generate scientific proposals and innovative approaches to solve analytical challenges.
- Serve as Analytical Lead and subject matter expert on cross-functional CMC development teams.
- Supervise and mentor one or more scientists; ensure effective team performance.
- Develop/optimize, qualify/validate, and transfer fit-for-purpose QC release and stability methods; provide oversight for QC testing at internal/external GMP labs.
- Plan, author, and review regulatory submission documents, health authority responses, technical reports, lab data, and method qualification/validation protocols.
- Publish and present posters/oral presentations at industry conferences.
Qualifications (Required)
- Degree in Chemistry/Biochemistry/Analytical Chemistry or related field (PhD +6 yrs, MS +12 yrs, BS +14 yrs relevant industry experience).
- Solid protein chemistry/biochemistry knowledge for biotherapeutic development.
- Analytical method development expertise for biologics; hands-on capillary electrophoresis and HPLC.
- Experience with biologics CMC development; QC qualification/validation; method transfer.
- Ability to interpret complex data and solve technical problems.
- Experience contributing to regulatory submissions and responding to health authority questions.
- Strong leadership, communication, collaboration; experience mentoring/supervising.
- Track record of publications/conference presentations (preferred).
- Ability to work independently in a fast-paced, collaborative environment; manage multiple projects.
Preferred Attributes
- Deep understanding of biologics analytics, impurity profiling, and protein characterization; cross-functional influence; strong organization; commitment to quality and continuous improvement.
Benefits
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k) (eligible employees); long-term incentive program eligibility.