Associate Director, MS&T Raw Material Specialist

Gaithersburg, US | Full time

About the role

As 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 with 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

Pay

Expected Pay Range: $146,300/year to $234,100/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.

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