Senior Scientist, Process Development
BioNTech SE
September 02, 2026
On-site
Gaithersburg, MD
Operations
Your Contribution:
- Develop and qualify scale-down models for downstream purification processes for monoclonal antibody manufacturing.
- Execute studies and FMEA assessments to establish critical process parameters and proven acceptable ranges.
- Lead development, optimization, and characterization of downstream processes (scale-up, virus/impurity clearance, resin/membrane lifetime).
- Conduct downstream unit operations: depth filtration, chromatography, viral inactivation, viral filtration, tangential flow filtration, and formulation.
- Collaborate cross-functionally to design experiments, analyze results, support technology transfers, and meet timelines.
- Draft CMC documentation (process descriptions, characterization reports, QbD risk assessments, and other technical reports).
- Drive best practices and workflows for process development.
A Good Match:
- PhD in Biomedical Engineering, Chemical Engineering, Biochemistry or related with 6+ years relevant experience (incl. postdoc), or MS with 8+ years industry experience.
- 6+ years global pharma PD or MS&T for monoclonal antibodies/related biologics.
- Downstream process development expertise (scale-up, technology transfer).
- Ability to design/execute process characterization using scale-down models to inform PPQ strategy.
- Strong biologics CMC knowledge including PPQ/BLA readiness; antibody/ADC experience preferred.
- Technical leadership in cross-functional teams.
- Travel willingness as required.
Benefits/Remuneration (as stated):
- Expected pay range: $113,600–$181,600/year + benefits, annual bonus & equity (variable).
Application Instructions:
- Apply for the Gaithersburg, US location via the online form and submit documents.
- Develop and qualify scale-down models for downstream purification processes for monoclonal antibody manufacturing.
- Execute studies and FMEA assessments to establish critical process parameters and proven acceptable ranges.
- Lead development, optimization, and characterization of downstream processes (scale-up, virus/impurity clearance, resin/membrane lifetime).
- Conduct downstream unit operations: depth filtration, chromatography, viral inactivation, viral filtration, tangential flow filtration, and formulation.
- Collaborate cross-functionally to design experiments, analyze results, support technology transfers, and meet timelines.
- Draft CMC documentation (process descriptions, characterization reports, QbD risk assessments, and other technical reports).
- Drive best practices and workflows for process development.
A Good Match:
- PhD in Biomedical Engineering, Chemical Engineering, Biochemistry or related with 6+ years relevant experience (incl. postdoc), or MS with 8+ years industry experience.
- 6+ years global pharma PD or MS&T for monoclonal antibodies/related biologics.
- Downstream process development expertise (scale-up, technology transfer).
- Ability to design/execute process characterization using scale-down models to inform PPQ strategy.
- Strong biologics CMC knowledge including PPQ/BLA readiness; antibody/ADC experience preferred.
- Technical leadership in cross-functional teams.
- Travel willingness as required.
Benefits/Remuneration (as stated):
- Expected pay range: $113,600–$181,600/year + benefits, annual bonus & equity (variable).
Application Instructions:
- Apply for the Gaithersburg, US location via the online form and submit documents.