Senior Scientist, Process Development
BioNTech SE
August 12, 2026
On-site
Gaithersburg, MD
Operations
Your Contribution:
- Develop and qualify scale-down models for downstream purification processes to support monoclonal antibody manufacturing
- Execute studies and FMEA assessments to establish critical process parameters and proven acceptable ranges for process characterization
- Lead development, optimization, and characterization of downstream processes, including scale-up, virus/impurity clearance, and resin/membrane lifetime
- Conduct downstream process unit operations such as depth filtration, chromatography, viral inactivation, viral filtration, tangential flow filtration, and formulation
- Collaborate with cross-functional teams to design experiments, analyze results, support technology transfers, and meet project timelines
- Contribute to CMC documentation by drafting process descriptions, characterization reports, QbD risk assessments, and other technical reports
- Drive the creation of best practices and workflows for process development in a fast-paced environment
A Good Match:
- PhD in Biomedical Engineering, Chemical Engineering, Biochemistry or related discipline with 6+ years of relevant experience (including post-doctoral training), or MS with 8+ years of industry experience
- 6 years’ experience in global pharma PD or MS&T for monoclonal antibodies or related biologics
- Expertise in downstream process development including scale-up and technology transfer
- Proven ability to design and execute process characterization studies using scale-down models that inform PPQ strategy
- Strong understanding of biologics CMC processes including PPQ/BLA readiness; antibody or ADC development preferred
- Demonstrated technical leadership within cross-functional teams and programs
- Willingness to travel domestically and internationally as required
Benefits:
- Expected Pay Range: $113,600/year to $181,600/year + benefits, annual bonus & equity
Apply now: Apply for the Gaithersburg, US location using the online form.
- Develop and qualify scale-down models for downstream purification processes to support monoclonal antibody manufacturing
- Execute studies and FMEA assessments to establish critical process parameters and proven acceptable ranges for process characterization
- Lead development, optimization, and characterization of downstream processes, including scale-up, virus/impurity clearance, and resin/membrane lifetime
- Conduct downstream process unit operations such as depth filtration, chromatography, viral inactivation, viral filtration, tangential flow filtration, and formulation
- Collaborate with cross-functional teams to design experiments, analyze results, support technology transfers, and meet project timelines
- Contribute to CMC documentation by drafting process descriptions, characterization reports, QbD risk assessments, and other technical reports
- Drive the creation of best practices and workflows for process development in a fast-paced environment
A Good Match:
- PhD in Biomedical Engineering, Chemical Engineering, Biochemistry or related discipline with 6+ years of relevant experience (including post-doctoral training), or MS with 8+ years of industry experience
- 6 years’ experience in global pharma PD or MS&T for monoclonal antibodies or related biologics
- Expertise in downstream process development including scale-up and technology transfer
- Proven ability to design and execute process characterization studies using scale-down models that inform PPQ strategy
- Strong understanding of biologics CMC processes including PPQ/BLA readiness; antibody or ADC development preferred
- Demonstrated technical leadership within cross-functional teams and programs
- Willingness to travel domestically and internationally as required
Benefits:
- Expected Pay Range: $113,600/year to $181,600/year + benefits, annual bonus & equity
Apply now: Apply for the Gaithersburg, US location using the online form.