Associate Director, Projects & Strategy, Analytics, Science & Technology (AS&T)
BioNTech SE
June 30, 2026
Remote friendly (Gaithersburg, MD)
United States
IT
About the Role:
As Associate Director, AS&T Projects & Strategy, you will advance late-stage protein pipeline for Monoclonal Antibodies (mAbs) and Antibody-Drug Conjugates (ADCs). Serve as main point of contact and oversee coordination of analytical activities across internal teams and external analytical partners, representing the analytical network within cross-functional late-stage CMC teams.
Your Contribution:
- Represent the analytical function within cross-functional project teams; primary interface for the CMC team and stakeholders.
- Coordinate analytical deliverables across internal functions and external partners, aligned with analytical development strategy.
- Shape and align analytical control strategy with Regulatory Affairs, CMC, and Quality to meet regulatory expectations.
- Lead and oversee analytical activities; communicate progress, timelines, risks, and challenges.
- Maintain end-to-end ownership of analytical components of the CMC Module 3 dossier (preparation, review, lifecycle maintenance).
A Good Match:
- Advanced degree (Biology, Chemistry, Pharmacy, Biotechnology, or related) plus 10+ years in a regulated pharmaceutical environment.
- Analytical experience (AS&T, Quality Control, Analytical Development) focused on mAbs, multi-specific antibodies, and/or ADCs.
- Late-stage analytical development and commercial support track record for antibody-based products (ideally including ADCs).
- Leadership experience managing analytical projects.
- Deep knowledge of US/EU regulatory frameworks (FDA/EMA), CMC analytical documentation, GMP, USP/Ph. Eur.
- Strong organizational, communication, stakeholder management, and cross-functional/global collaboration skills.
- Preferred advantage: pre-approval activities experience (PLI readiness, BLA preparation, product launch).
Application:
Apply for the Gaithersburg location and submit documents via the online form.
As Associate Director, AS&T Projects & Strategy, you will advance late-stage protein pipeline for Monoclonal Antibodies (mAbs) and Antibody-Drug Conjugates (ADCs). Serve as main point of contact and oversee coordination of analytical activities across internal teams and external analytical partners, representing the analytical network within cross-functional late-stage CMC teams.
Your Contribution:
- Represent the analytical function within cross-functional project teams; primary interface for the CMC team and stakeholders.
- Coordinate analytical deliverables across internal functions and external partners, aligned with analytical development strategy.
- Shape and align analytical control strategy with Regulatory Affairs, CMC, and Quality to meet regulatory expectations.
- Lead and oversee analytical activities; communicate progress, timelines, risks, and challenges.
- Maintain end-to-end ownership of analytical components of the CMC Module 3 dossier (preparation, review, lifecycle maintenance).
A Good Match:
- Advanced degree (Biology, Chemistry, Pharmacy, Biotechnology, or related) plus 10+ years in a regulated pharmaceutical environment.
- Analytical experience (AS&T, Quality Control, Analytical Development) focused on mAbs, multi-specific antibodies, and/or ADCs.
- Late-stage analytical development and commercial support track record for antibody-based products (ideally including ADCs).
- Leadership experience managing analytical projects.
- Deep knowledge of US/EU regulatory frameworks (FDA/EMA), CMC analytical documentation, GMP, USP/Ph. Eur.
- Strong organizational, communication, stakeholder management, and cross-functional/global collaboration skills.
- Preferred advantage: pre-approval activities experience (PLI readiness, BLA preparation, product launch).
Application:
Apply for the Gaithersburg location and submit documents via the online form.