Associate Director, Raw Material MSAT – Lifecycle & Quality

Biopharma Careers; Gaithersburg (MD); On-site; USD 146,000 - 234,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

401(K) Plan with Company Match

Tuition Reimbursement & Student Loan

Job summary

BioNTech US is seeking an Associate Director, MSAT Raw Material Specialist to shape our manufacturing strategy by developing frameworks for raw material lifecycle management and ensuring manufacturability, quality, and stability for our mRNA-based therapeutics.

You will lead cross-functional programs, define material attributes linked to process performance, and contribute to regulatory submissions while ensuring cGMP compliance across teams.

Qualifications

• MS or PhD in Biochemical Engineering, Chemical Engineering, Pharmaceutical Sciences, or related field.
• 6+ years of industry experience in CMC, biologics, or mRNA platforms.
• Deep knowledge of raw material risk assessments, characterization, and control strategies.

Responsibilities

• Develop and implement strategic frameworks for raw material knowledge transfer and lifecycle management.
• Lead cross-functional initiatives to develop material control strategies ensuring quality and manufacturability.
• Define critical material attributes linked to process performance and robustness.
• Act as SME on raw material science within CMC technical teams.
• Conduct risk assessments, supplier evaluations, and manage post-approval changes.
• Collaborate on regulatory submissions and health authority interactions.

Skills

Raw material knowledge transfer

Lifecycle management

Cross-functional collaboration

Material control strategies

Regulatory awareness

Communication skills

Influence across teams

Product lifecycle management

cGMP understanding

Education

MS or PhD in Biochemical Engineering / Chemical Engineering / Pharmaceutical Sciences

Job description

BioNTech US is seeking an Associate Director, MSAT Raw Material Specialist to shape our manufacturing strategy by developing frameworks for raw material lifecycle management and ensuring manufacturability, quality, and stability for our mRNA-based therapeutics.

You will lead cross-functional programs, define material attributes linked to process performance, and contribute to regulatory submissions while ensuring cGMP compliance across teams.