Associate Director, MS&T Raw Material Specialist

Gaithersburg, US | full time | Job ID: 11630

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.

Your contribution:

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

A good match:

MS or PhD in Biochemical Engineering, Chemical Engineering, Pharmaceutical Sciences, or related field with 6 plus 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

Your benefits and remuneration:

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.

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 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!

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