Senior Scientist II, Process Development

BioNTech•Gaithersburg, MD

2d•Onsite

About The Position

As a Senior Scientist II in Process Development, you will play a pivotal role in advancing BioNTech’s antibody pipeline—a cornerstone of our therapeutic strategy. Your expertise will contribute directly to shaping downstream processing development and supporting CMC strategies for regulatory submissions. You will be part of a collaborative, lab-based team that thrives on innovation and precision. Together, we aim to redefine process development standards while contributing to BioNTech’s mission of pioneering immunotherapy solutions. This is your opportunity to influence key departmental goals and make a tangible impact.

Requirements

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

Nice To Haves

Late-stage/BLA experience

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

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
…and more!
More details to be shared.