Gaithersburg, US | full time | Job ID: 10717

About the Role:

As a Senior Manager for the MSAT Downstream Laboratory, you will provide scientific and strategic leadership to advance BioNTech’s antibody and ADC programs. You will play a critical role in designing, developing, and qualifying downstream processes while fostering innovation and continuous improvement in late-stage development and commercialization.

In this role, you will lead a collaborative team environment, working closely with internal departments such as Process Development, Analytical Development, Quality, Regulatory Affairs, and external partners to ensure seamless technology transfers and GMP readiness. Your expertise will directly support BioNTech’s mission to deliver high-quality therapies to patients worldwide.

Your Contribution:

• Provide scientific and strategic leadership for the Gaithersburg MSAT Downstream Laboratory
• Collaborate across teams (Supply Chain, Process Development, AS&T, Analytical Development, Quality, Regulatory) to establish and run upstream MSAT laboratory operations
• Develop phase-appropriate downstream scale-down models for antibody programs
• Lead knowledge and technology transfers for antibody and ADC programs to enable downstream characterization, investigational studies, and scale-down model execution
• Coach and develop MSAT team members on downstream antibody manufacturing processes and foster a culture of scientific rigor and continuous improvement
  Design, develop, characterize, qualify downstream processes including chromatography, filtration, viral inactivation/filtration, UFDF concentration/formulation/cryopreservation
• Draft SOPs, reports, presentations; maintain instrumentation/equipment; troubleshoot issues as needed
• Collaborate with internal teams and external groups to advance late-stage antibody capabilities
• Contribute to PPQ protocol authoring/review ensuring GMP compliance and scientific rigor

A Good Match:

• Master's degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering or related discipline with 12 plus years of pharmaceutical/biotechnology process development industry experience.
• In-depth CMC knowledge in early or late-stage antibody technology transfer projects with sound understanding of all stages of antibody drug development (GMP/QbD approach)
• Proven success leading cross-functional CMC teams with strong organizational skills and stakeholder/client management expertise
• Experience as subject matter expert for antibody downstream processes including technology transfer projects/product commercialization
• Demonstrated ability to design complex projects while shaping scientific strategy at both platform/program levels
• Strong collaboration skills across GMP Manufacturing, Quality Control/Assurance teams within technology transfer projects

Preferred Qualifications: PhD in a relevant field

US based candidates expected Pay Range: $168,100 - $268,700/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.