Associate Director, MS&T Raw Material Specialist

Role

Associate Director, MSAT Raw Material Specialist, responsible for developing and executing strategies for raw material lifecycle management in biologics or mRNA manufacturing.

Ensuring product quality, manufacturability, and regulatory compliance through material science expertise.

• Responsibilities encompass leading cross-functional initiatives, defining critical material attributes linked to process robustness, conducting risk assessments, supplier evaluations, managing post-approval changes, and supporting regulatory submissions.

• MS or PhD in Biochemical Engineering, Chemical Engineering, Pharmaceutical Sciences, or related fields.
• 6+ years' industry experience with deep knowledge of CMC processes for biologics or mRNA platforms, including technology transfer, lifecycle management, and GMP compliance.

• Expertise in raw material risk assessments, characterization, control strategies, and understanding of regulatory expectations.

• Focus on biologics or mRNA modalities, GMP manufacturing, lifecycle management, post-approval changes, regulatory interactions, and raw material science.

Based in Gaithersburg, MD, with a comprehensive benefits package, competitive salary range, and potential variable bonus/equity.