Associate Director, MS&T Raw Material Specialist

About the Position

Associate Director, MS&T Raw Material Specialist

Gaithersburg, US | Full Time | Job ID: 11630

As an Associate Director, MSAT Raw Material Specialist, you will play a pivotal role in shaping BioNTech’s manufacturing success by developing and implementing strategic frameworks for raw material lifecycle management. Your contributions will ensure reliable manufacturability, product quality, and stability for our innovative mRNA-based therapeutics. Working closely with cross-functional teams, you’ll be at the forefront of material science innovation and regulatory compliance, contributing to the advancement of transformative healthcare solutions.

Responsibilities

• Develop and implement strategic frameworks for raw material knowledge transfer and lifecycle management
• Lead cross-functional initiatives to develop material control strategies that ensure product quality and manufacturability
• Define critical material attributes and their linkage to process performance and robustness
• Act as the subject matter expert on raw material science within CMC technical teams
• Conduct risk assessments, supplier evaluations, and manage post-approval changes related to raw materials
• Collaborate on regulatory submissions and health authority interactions regarding material science topics

Requirements

• MS or PhD in Biochemical Engineering, Chemical Engineering, Pharmaceutical Sciences, or related field
• 6+ years of industry experience
• Deep knowledge of CMC processes for biologics or mRNA platforms, including technology transfer and lifecycle management
• Proven expertise in raw material risk assessments, characterization, and control strategies for GMP manufacturing
• Strong organizational, problem-solving, and communication skills with the ability to influence decisions across teams
• Experience with commercial product lifecycle management including post-approval changes and supplier updates
• Comprehensive understanding of cGMP requirements and regulatory expectations related to raw materials

We Offer

• Expected Pay Range: $146,300/year to $234,100/year + benefits, annual bonus & equity
• 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

About the Company

Located in the BioHealth 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!

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 ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

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BioNTech, the story

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!

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