Senior Sterile Drug Product Engineer & Tech Lead

Viking Therapeutics; San Diego (CA); Sur place; USD 180 000 - 280 000; Plein temps

Résumé du poste

Viking Therapeutics in San Diego seeks an Engineer of Sterile Drug Product to lead sterile injectable manufacturing strategy, tech transfer, and process validation across the pipeline. You will collaborate with CMC, Device Development, QA, Regulatory Affairs, and Supply Chain to ensure compliant, scalable manufacturing for prefilled syringes and vials.

In this senior role, you will direct technology transfer, PPQ, CPV programs, and continuous process verification, while guiding external CMOs and

Qualifications

• Ten or more years in sterile injectable manufacturing or MS&T.
• Experience leading external CMOs/CDMOs and technology transfer.
• Strong knowledge of regulatory requirements for parenteral products.
• Proven ability to lead cross-functional teams.

Responsabilités

• Lead strategy for sterile drug product manufacturing.
• Oversee technology transfer and scale‑up to clinical/commercial sites.
• Develop and govern PPQ, CPV, and validation programs.
• Ensure regulatory readiness and quality compliance.

Connaissances

Sterile manufacturing

Technology transfer

Process validation

Quality systems

Regulatory submissions

Formation

Bachelor's in Chemical/Pharmaceutical Sciences

Advanced degree (MS/PhD) preferred

Outils

JMP

Minitab

Description du poste

Viking Therapeutics in San Diego seeks an Engineer of Sterile Drug Product to lead sterile injectable manufacturing strategy, tech transfer, and process validation across the pipeline. You will collaborate with CMC, Device Development, QA, Regulatory Affairs, and Supply Chain to ensure compliant, scalable manufacturing for prefilled syringes and vials.

In this senior role, you will direct technology transfer, PPQ, CPV programs, and continuous process verification, while guiding external CMOs and