Director, MSAT Upstream 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 Upstream Laboratory
- Collaborate across teams (Supply Chain, Process Development, AS&T, Analytical Development, Quality, Regulatory) to establish and run MSAT Upstream Laboratory operations
- Develop phase-appropriate upstream scale-down models for antibody programs
- Lead knowledge and technology transfers for antibody and ADC programs to enable upstream characterization, investigational studies, and scale-down model execution
- Coach and develop MSAT team members on upstream antibody manufacturing processes; foster scientific rigor and continuous improvement
- Design, develop, characterize, and qualify upstream processes including cell processing, culture/expansion, harvest, and cryopreservation
- Draft SOPs, reports, and presentations; maintain instrumentation/equipment; troubleshoot issues
- Collaborate with internal and external groups to advance late-stage antibody capabilities
- Contribute to PPQ protocol/report authoring to ensure GMP compliance and scientific rigor
Qualifications / Skills:
- Master’s degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, or related field; 12+ years of pharmaceutical/biotechnology process development experience
- In-depth CMC knowledge in early or late-stage antibody technology transfer projects; understanding of antibody drug development stages using GMP/QbD
- Proven success leading cross-functional CMC teams; strong organizational and stakeholder/client management skills
- Experience as subject matter expert for antibody upstream processes, including technology transfer and product commercialization
- Ability to design complex projects and shape scientific strategy at platform/program levels
- Strong collaboration across GMP Manufacturing and Quality Control/Assurance teams
- Preferred: PhD in a relevant field
Benefits (if explicitly stated):
- Medical, Dental, and Vision Insurance; Life, AD&D, Critical Illness Insurance; pre-tax HSA/FSA and DCRA spending accounts
- Employee Assistance & Concierge Program (EAP) 24/7
- Parental and Childbirth Leave & Family Planning Assistance; Paid Time Off; 401(k) plan with company match
- Tuition reimbursement/student loan assistance; professional development programs; commuting allowance and subsidized parking; discounted insurance
- Plus annual bonus & equity (variable) and annual pay range: $168,100–$268,700/year + benefits
Application instructions:
- Apply for the Gaithersburg, US location via the online form and submit your documents
- Provide scientific and strategic leadership for the Gaithersburg MSAT Upstream Laboratory
- Collaborate across teams (Supply Chain, Process Development, AS&T, Analytical Development, Quality, Regulatory) to establish and run MSAT Upstream Laboratory operations
- Develop phase-appropriate upstream scale-down models for antibody programs
- Lead knowledge and technology transfers for antibody and ADC programs to enable upstream characterization, investigational studies, and scale-down model execution
- Coach and develop MSAT team members on upstream antibody manufacturing processes; foster scientific rigor and continuous improvement
- Design, develop, characterize, and qualify upstream processes including cell processing, culture/expansion, harvest, and cryopreservation
- Draft SOPs, reports, and presentations; maintain instrumentation/equipment; troubleshoot issues
- Collaborate with internal and external groups to advance late-stage antibody capabilities
- Contribute to PPQ protocol/report authoring to ensure GMP compliance and scientific rigor
Qualifications / Skills:
- Master’s degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, or related field; 12+ years of pharmaceutical/biotechnology process development experience
- In-depth CMC knowledge in early or late-stage antibody technology transfer projects; understanding of antibody drug development stages using GMP/QbD
- Proven success leading cross-functional CMC teams; strong organizational and stakeholder/client management skills
- Experience as subject matter expert for antibody upstream processes, including technology transfer and product commercialization
- Ability to design complex projects and shape scientific strategy at platform/program levels
- Strong collaboration across GMP Manufacturing and Quality Control/Assurance teams
- Preferred: PhD in a relevant field
Benefits (if explicitly stated):
- Medical, Dental, and Vision Insurance; Life, AD&D, Critical Illness Insurance; pre-tax HSA/FSA and DCRA spending accounts
- Employee Assistance & Concierge Program (EAP) 24/7
- Parental and Childbirth Leave & Family Planning Assistance; Paid Time Off; 401(k) plan with company match
- Tuition reimbursement/student loan assistance; professional development programs; commuting allowance and subsidized parking; discounted insurance
- Plus annual bonus & equity (variable) and annual pay range: $168,100–$268,700/year + benefits
Application instructions:
- Apply for the Gaithersburg, US location via the online form and submit your documents