Gaithersburg, US | full time | Job ID: 10715

About the Role:

As Senior Director of Global MSAT, you will play a pivotal leadership role in advancing BioNTech’s late-stage products and innovative technologies. Reporting to the Executive Director of Global MSAT, you will hold both functional and enterprise accountabilities, ensuring products are technically feasible for commercialization while meeting CMC regulatory requirements.

You will lead and develop a team responsible for MSAT activities, collaborating closely with Global Technical Development and Global Supply Operations to drive product development and manufacturing strategies. This high-visibility role requires hands-on leadership, cross-functional collaboration, and a commitment to fostering a culture of continuous improvement across local, regional, and global levels.

Your Contribution:

• Establish BioNTech’s Global Technical Operations Product Champion team to optimize CMC handovers and procedures
• Provide hands-on leadership by coaching, mentoring, collaborating, and partnering at all organizational levels locally and globally
• Align and deliver goals across functional, site, regional, and global levels as an enterprise leader
• Develop long-term manufacturing strategies aligned with site and global initiatives, including introducing new technologies/processes into manufacturing operations
• Lead commercial product CMC lifecycle activities such as post-approval change management, product risk management, and process monitoring
• Create a culture of continuous improvement by actively managing employees, solving challenges, analyzing data, and driving efficiency improvements
• Provide strategic direction for MSAT team development aligned with pipeline strategy and global manufacturing vision
• Collaborate with late-stage development teams to support process/technology implementation, site process qualification/comparability campaigns, deviation investigations/product assessments, process monitoring/improvement efforts
• Offer technical support for regulatory filings/inspections and address health authority questions when needed
• Implement fit-for-purpose systems/business processes globally to ensure compliance with corporate guidelines for deviation investigations, technology transfer, process monitoring, raw material qualification

A Good Match:

• Bachelor’s Degree in Engineering, Life Sciences or related discipline with 15 plus years of biopharmaceutical industry experience in manufacturing/MSAT/process development roles; strong technical foundation in antibody development/manufacturing required
• Experience leading direct reports and managing in a complex matrix environment at local/global levels
• Proficient knowledge of manufacturing processes, CMC requirements/process technologies/regulatory requirements
• Expertise in lean manufacturing/lean six sigma methodologies
• Excellent communication skills with proven ability to collaborate/influence across all levels of management
• Strong analytical/organizational/problem-solving/project management skills coupled with adaptability in evolving environments
• Passion for building organizations/processes/systems/people while fostering innovation

US based candidates expected Pay Range: $198,900 to $318,300/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.