BioNTech SE · 21 hours ago
Senior Scientist II, Process Development
Gaithersburg 25 West Watkins
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expBioNTech SE is a leading biotechnology company focused on pioneering immunotherapy solutions. As a Senior Scientist II in Process Development, you will play a pivotal role in advancing the antibody pipeline and contribute to shaping downstream processing development for regulatory submissions.
Health Care
Responsibilities
Develop and qualify scale-down models for downstream purification processes to support monoclonal antibody manufacturing
Lead studies and FMEA assessments to establish critical process parameters and proven acceptable ranges
Optimize and characterize downstream processes including virus/impurity clearance, resin/membrane lifetime, and scale-up
Execute all unit operations in downstream processing such as chromatography, viral filtration, and formulation
Collaborate with cross-functional teams to design experiments, analyze results, support tech transfers, and ensure BLA readiness
Contribute to CMC documentation by preparing process descriptions, protocols/reports, and QbD risk assessments
Qualification
Required
PhD in Biomedical Engineering, Chemical Engineering, Biochemistry or related field with 8 plus years' relevant experience; or MS with 12 plus years of industry experience
Extensive background in global pharma PD or MS&T for monoclonal antibodies or biologics
Proven expertise in downstream process development including scale-up and technology transfer
Demonstrated ability to conduct process characterization using DoE studies in scale-down models
Solid understanding of biologics CMC with experience supporting PPQ/BLA readiness
Strong leadership skills within cross-department technical teams
Open-minded approach to ambiguity with a drive for innovation
Preferred
Late-stage/BLA experience
Benefits
Medical, Dental and Vision Insurance
Life, AD&D, Critical Illness Insurance
Pre-tax HSA & FSA, DCRA Spending Accounts
Employee Assistance & Concierge Program (EAP) available 24/7
Parental and Childbirth Leave & Family Planning Assistance
Sitterstream: Virtual Tutoring & Childcare Membership
Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
401(K) Plan with Company Match
Tuition Reimbursement & Student Loan Assistance Programs
Wellbeing Incentive Platforms & Incentives
Professional Development Programs
Commuting Allowance and subsidized parking
Discounted Home, Auto & Pet Insurance
Company
BioNTech SE
At BioNTech we understand that every cancer patient’s tumor is unique and therefore each patient’s treatment should be individualized.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
James Ryan
Chief Legal Officer and Chief Business Officer
Recent News
2025-10-21
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