Director, Analytical Development

Job description

Gaithersburg, US | full time | Job ID: 11211 About the Role: As Director of Analytical Development, you will play a pivotal role in advancing BioNTech’s mission to revolutionize medicine. Your work will drive analytical strategy and execution for antibody and ADC programs, ensuring readiness for regulatory milestones such as BLA submissions. Partnering with cross-functional teams in Process Development, Global Technical Development, AS&T, Regulatory, and Quality, you will operate primarily in non-GMP laboratories to deliver impactful solutions that shape the future of biologics development. This role offers an opportunity to lead innovative analytical strategies in a dynamic environment where your contributions will directly influence global regulatory submissions and product commercialization. Your Contribution: Collaborate with SMEs and GTD leads to develop robust methods, analytical control strategies, and seamless transfer packages Proactively identify analytical risks and data gaps; design and implement risk mitigation studies (e.g., characterization, comparability, stability) Establish internal best practices for phase-appropriate CMC hand-offs and analytical playbooks Define...