Associate Director, Projects & Strategy, Analytical Sciences & Technology (AS&T)
BioNTech SE
August 12, 2026
On-site
Gaithersburg, MD
Operations
Responsibilities:
- Represent the analytical function within cross-functional project teams and act as the primary interface for the CMC team and other key stakeholders.
- Coordinate analytical deliverables across internal analytical functions and external partners, ensuring alignment with the overall analytical development strategy.
- Shape and align the analytical control strategy with Regulatory Affairs, CMC, and Quality to ensure compliance with regulatory expectations and health authority requirements.
- Provide leadership and oversight for analytical activities, communicating progress, timelines, risks, and challenges.
- Maintain end-to-end ownership of the analytical components of the CMC Module 3 dossier, including document preparation, review, and lifecycle maintenance.
Qualifications:
- Advanced degree in Biology, Chemistry, Pharmacy, Biotechnology, or related field; plus 10+ years’ experience in a regulated pharmaceutical environment.
- Broad experience in analytical functions (AS&T, Quality Control, or Analytical Development) focused on mAbs, multi-specific antibodies, and/or ADCs.
- Strong late-stage analytical development and commercial support experience for antibody-based products (ideally ADCs).
- Demonstrated leadership and analytical project management experience.
- Deep understanding of US/EU regulatory frameworks (EMA, FDA), CMC analytical development documentation, GMP, and compendial standards (USP, Ph. Eur.).
- Strong organizational, communication, stakeholder management, and intercultural cross-functional skills.
- Pre-approval support experience (e.g., PLI readiness, BLA preparation, product launch) is an advantage.
Your benefits and remuneration (as stated): Expected pay range $146,300/year to $234,100/year + benefits, annual bonus & equity.
Apply: Apply for the Gaithersburg location and submit documents via the online form.
- Represent the analytical function within cross-functional project teams and act as the primary interface for the CMC team and other key stakeholders.
- Coordinate analytical deliverables across internal analytical functions and external partners, ensuring alignment with the overall analytical development strategy.
- Shape and align the analytical control strategy with Regulatory Affairs, CMC, and Quality to ensure compliance with regulatory expectations and health authority requirements.
- Provide leadership and oversight for analytical activities, communicating progress, timelines, risks, and challenges.
- Maintain end-to-end ownership of the analytical components of the CMC Module 3 dossier, including document preparation, review, and lifecycle maintenance.
Qualifications:
- Advanced degree in Biology, Chemistry, Pharmacy, Biotechnology, or related field; plus 10+ years’ experience in a regulated pharmaceutical environment.
- Broad experience in analytical functions (AS&T, Quality Control, or Analytical Development) focused on mAbs, multi-specific antibodies, and/or ADCs.
- Strong late-stage analytical development and commercial support experience for antibody-based products (ideally ADCs).
- Demonstrated leadership and analytical project management experience.
- Deep understanding of US/EU regulatory frameworks (EMA, FDA), CMC analytical development documentation, GMP, and compendial standards (USP, Ph. Eur.).
- Strong organizational, communication, stakeholder management, and intercultural cross-functional skills.
- Pre-approval support experience (e.g., PLI readiness, BLA preparation, product launch) is an advantage.
Your benefits and remuneration (as stated): Expected pay range $146,300/year to $234,100/year + benefits, annual bonus & equity.
Apply: Apply for the Gaithersburg location and submit documents via the online form.