Director, MS&T Downstream Laboratory Lead

BioNTech•Gaithersburg, MD

31d

About The Position

As a Senior Manager for the MSAT Downstream Laboratory, you will provide scientific and strategic leadership to advance BioNTech’s antibody and ADC programs. You will play a critical role in designing, developing, and qualifying downstream processes while fostering innovation and continuous improvement in late-stage development and commercialization. In this role, you will lead a collaborative team environment, working closely with internal departments such as Process Development, Analytical Development, Quality, Regulatory Affairs, and external partners to ensure seamless technology transfers and GMP readiness. Your expertise will directly support BioNTech’s mission to deliver high-quality therapies to patients worldwide.

Requirements

Master's degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering or related discipline with 12 plus years of pharmaceutical/biotechnology process development industry experience.
In-depth CMC knowledge in early or late-stage antibody technology transfer projects with sound understanding of all stages of antibody drug development (GMP/QbD approach)
Proven success leading cross-functional CMC teams with strong organizational skills and stakeholder/client management expertise
Experience as subject matter expert for antibody downstream processes including technology transfer projects/product commercialization
Demonstrated ability to design complex projects while shaping scientific strategy at both platform/program levels
Strong collaboration skills across GMP Manufacturing, Quality Control/Assurance teams within technology transfer projects

Nice To Haves

PhD in a relevant field

Responsibilities

Provide scientific and strategic leadership for the Gaithersburg MSAT Downstream Laboratory
Collaborate across teams (Supply Chain, Process Development, AS&T, Analytical Development, Quality, Regulatory) to establish and run upstream MSAT laboratory operations
Develop phase-appropriate downstream scale-down models for antibody programs
Lead knowledge and technology transfers for antibody and ADC programs to enable downstream characterization, investigational studies, and scale-down model execution
Coach and develop MSAT team members on downstream antibody manufacturing processes and foster a culture of scientific rigor and continuous improvementDesign, develop, characterize, qualify downstream processes including chromatography, filtration, viral inactivation/filtration, UFDF concentration/formulation/cryopreservation
Draft SOPs, reports, presentations; maintain instrumentation/equipment; troubleshoot issues as needed
Collaborate with internal teams and external groups to advance late-stage antibody capabilities
Contribute to PPQ protocol authoring/review ensuring GMP compliance and scientific rigor