About the job
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Position Overview:
The Director of Drug Substance (DS) Commercialization for Critical Raw Materials will spearhead the launch readiness and commercial supply of essential raw materials for the production of engineered Critical Raw Materials (eCRM) and related components for glycoconjugate vaccines. This role encompasses serving as the technical lead and Subject Matter Expert (SME) on biologic raw material processes. The primary focus is on technical launch planning and execution, utilizing best practices while coordinating cross-functional efforts for regulatory submissions, facility readiness, launch supplies, and post-launch process robustness initiatives.
This position also involves providing leadership to ensure effective communication regarding the scientific and commercial rationale behind critical raw material manufacturing processes to internal stakeholders, Contract Manufacturing Organizations (CMOs), and regulatory agencies. The incumbent will collaborate with the organization to guarantee timely execution and meticulous planning for commercial lifecycle management.
This position reports to the Senior Director of Global DS Commercialization, Protein.

