Senior Engineer, Sterile Injectable Drug Product

Viking Therapeutics, Inc.

California

Sur place

USD 180 000 - 230 000

Plein temps

Il y a 6 jours

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Résumé du poste

Viking Therapeutics, Inc. seeks an experienced Engineer of Sterile Drug Product to lead strategic and technical oversight for aseptically filled injectables, technology transfer, and process validation.

You will partner with CMC, Device Development, Analytics, Quality, Regulatory Affairs, and Supply Chain to guide external CMOs/CDMOs and ensure regulatory readiness. Responsibilities include leading technology transfer, PPQ/CPV programs, and process validation across clinical and commercial

Qualifications

Experience in sterile injectable drug product manufacturing.
Experience leading external CMOs/CDMOs and supplier oversight.
Strong knowledge of FDA and EU regulatory guidance for drug products.
Travel 20–25% to manufacturing partners and suppliers.

Responsabilités

Lead sterile injectable drug product manufacturing strategy and oversight across programs.
Oversee technology transfer to clinical and commercial fill-finish sites.
Qualify and manage CMOs/CDMOs and critical components/suppliers.
Develop and supervise PPQ, CPV, and process validation strategies.
Lead investigations into deviations and CAPAs with Quality.
Prepare CMC drug product content for regulatory submissions.