Gaithersburg, US | full time | Job ID: 10993

About the Role:

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.

Your Contribution:

• 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

A Good Match:

• 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 qualifications: Late-stage/BLA experience

US based candidates expected Pay Range: $130,800 - $209,400/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

Your Benefits

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

• 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.

Located in the Bio Health Capital Region near Washington DC and ranked among the top biopharma hubs in the country, Gaithersburg, Maryland offers a unique and diverse cluster across industry, government, and academia for top talent and scientific innovation. As a pivotal player within the life sciences community, Gaithersburg is distinguished by its robust infrastructure and strategic location near the nation’s capital. The city’s strategic significance is amplified by its state-of-the-art manufacturing facilities that cater to the rigorous demands of the life sciences industry; Gaithersburg’s manufacturing sector is defined by advanced technologies and complies with the most stringent regulatory standards, ensuring the production of high-quality pharmaceuticals, biologics, and medical devices. In the coming years, Gaithersburg will continue to be a vital contributor to the future of medical science and technology.

Apply now

• We look forward to your application!

Apply for our Gaithersburg, US location and simply send us your documents using our online form.

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘Hire Right’. You will be informed accordingly by your BioNTech-Recruiter.