Director, MS&T Downstream Laboratory Lead
BioNTech SE
4 months ago
On-site
Gaithersburg, MD
$168,100 - $268,700 USD yearly
Operations
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; foster scientific rigor and continuous improvement.
- Design, develop, characterize, and qualify downstream processes including chromatography, filtration, viral inactivation/filtration, and UFDF concentration/formulation/cryopreservation.
- Draft SOPs, reports, and presentations; maintain instrumentation/equipment; troubleshoot issues.
- Collaborate with internal and external partners to advance late-stage antibody capabilities.
- Contribute to PPQ protocol authoring/review ensuring GMP compliance and scientific rigor.
Qualifications
- Master’s degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, or related discipline with 12+ years of pharmaceutical/biotechnology process development industry experience.
- In-depth CMC knowledge in early or late-stage antibody technology transfer projects; understanding of all stages of antibody drug development (GMP/QbD).
- Proven success leading cross-functional CMC teams; strong organizational and stakeholder/client management skills.
- Experience as subject matter expert for antibody downstream processes, including technology transfer projects/product commercialization.
- Ability to design complex projects and shape scientific strategy at platform/program levels.
- Strong collaboration skills across GMP Manufacturing and Quality Control/Assurance teams within technology transfer projects.
Preferred Qualifications
- PhD in a relevant field.
Benefits
- Medical, dental, and vision insurance; life/AD&D/critical illness insurance.
- Pre-tax HSA/FSA and DCRA spending accounts; 24/7 EAP.
- Parental/childbirth leave and family planning assistance; paid time off and U.S. shutdown.
- 401(k) plan with company match; tuition reimbursement and student loan assistance.
- Commuting allowance/subsidized parking; discounted home/auto/pet insurance.
Application Instructions
- Apply for the Gaithersburg, US location and submit documents via the online form.
- 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; foster scientific rigor and continuous improvement.
- Design, develop, characterize, and qualify downstream processes including chromatography, filtration, viral inactivation/filtration, and UFDF concentration/formulation/cryopreservation.
- Draft SOPs, reports, and presentations; maintain instrumentation/equipment; troubleshoot issues.
- Collaborate with internal and external partners to advance late-stage antibody capabilities.
- Contribute to PPQ protocol authoring/review ensuring GMP compliance and scientific rigor.
Qualifications
- Master’s degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, or related discipline with 12+ years of pharmaceutical/biotechnology process development industry experience.
- In-depth CMC knowledge in early or late-stage antibody technology transfer projects; understanding of all stages of antibody drug development (GMP/QbD).
- Proven success leading cross-functional CMC teams; strong organizational and stakeholder/client management skills.
- Experience as subject matter expert for antibody downstream processes, including technology transfer projects/product commercialization.
- Ability to design complex projects and shape scientific strategy at platform/program levels.
- Strong collaboration skills across GMP Manufacturing and Quality Control/Assurance teams within technology transfer projects.
Preferred Qualifications
- PhD in a relevant field.
Benefits
- Medical, dental, and vision insurance; life/AD&D/critical illness insurance.
- Pre-tax HSA/FSA and DCRA spending accounts; 24/7 EAP.
- Parental/childbirth leave and family planning assistance; paid time off and U.S. shutdown.
- 401(k) plan with company match; tuition reimbursement and student loan assistance.
- Commuting allowance/subsidized parking; discounted home/auto/pet insurance.
Application Instructions
- Apply for the Gaithersburg, US location and submit documents via the online form.