Associate Director, AS&T Lifecycle Management (Chemical Method Expert)
BioNTech SE
August 15, 2026
Remote friendly (Gaithersburg, MD)
United States
Operations
Responsibilities:
- Provide technical analytical expertise for the Gaithersburg antibody laboratory and late-stage/commercial projects across a global network.
- Design and perform method validations and transfers; manage method lifecycle activities (e.g., exchange of critical reagents, method performance and lab investigations); potential hands-on lab work.
- Participate in strategic/technical discussions cross-functionally with CMC teams and external partners.
- Evaluate and review technical and regulatory submission documents in time to support approval and market launch.
- Serve as analytical SME for regulatory filings; support responses to questions from health authorities.
Qualifications:
- Advanced degree in Biology, Chemistry, Pharmacy, Biotechnology, or related field; 10+ years’ experience in a regulated pharmaceutical environment.
- Expertise in ADC analytical methods: drug-to-antibody ratio, free drug, residual impurities, unconjugated antibody, conjugate variants, conjugated small-molecule impurities, charge variants; beneficial: HPLC, GC, mass spectrometry, NMR, IR for linker-payload intermediate.
- Hands-on assay development; experience designing/performance of method validations; data analysis and statistical evaluation.
- Strong CMC background for late-stage development and commercial biological products.
- In-depth knowledge of ICH guidelines, GMP regulations, and industry best practices.
- Proven experience with biological regulatory filings (IND/IMPD, BLA/MAA) and interactions with health authorities.
- Experience working in intercultural, cross-functional, global teams; structured approach to complex challenges.
Preferred:
- Experience managing method validation/transfer across external partners.
- Ability to lead/support QC quality events and root-cause investigations.
Application:
- Contact Yushen Chang (Talent Acquisition) or jobs@biontech.de with reference to Job ID 11547.
Benefits/Compensation:
- Expected pay range: $146,300/year to $234,100/year + benefits, annual bonus & equity (variable).
- Provide technical analytical expertise for the Gaithersburg antibody laboratory and late-stage/commercial projects across a global network.
- Design and perform method validations and transfers; manage method lifecycle activities (e.g., exchange of critical reagents, method performance and lab investigations); potential hands-on lab work.
- Participate in strategic/technical discussions cross-functionally with CMC teams and external partners.
- Evaluate and review technical and regulatory submission documents in time to support approval and market launch.
- Serve as analytical SME for regulatory filings; support responses to questions from health authorities.
Qualifications:
- Advanced degree in Biology, Chemistry, Pharmacy, Biotechnology, or related field; 10+ years’ experience in a regulated pharmaceutical environment.
- Expertise in ADC analytical methods: drug-to-antibody ratio, free drug, residual impurities, unconjugated antibody, conjugate variants, conjugated small-molecule impurities, charge variants; beneficial: HPLC, GC, mass spectrometry, NMR, IR for linker-payload intermediate.
- Hands-on assay development; experience designing/performance of method validations; data analysis and statistical evaluation.
- Strong CMC background for late-stage development and commercial biological products.
- In-depth knowledge of ICH guidelines, GMP regulations, and industry best practices.
- Proven experience with biological regulatory filings (IND/IMPD, BLA/MAA) and interactions with health authorities.
- Experience working in intercultural, cross-functional, global teams; structured approach to complex challenges.
Preferred:
- Experience managing method validation/transfer across external partners.
- Ability to lead/support QC quality events and root-cause investigations.
Application:
- Contact Yushen Chang (Talent Acquisition) or jobs@biontech.de with reference to Job ID 11547.
Benefits/Compensation:
- Expected pay range: $146,300/year to $234,100/year + benefits, annual bonus & equity (variable).