Senior Drug Product Engineer - Commercial Formulation Lead

Amgen; Thousand Oaks (CA); Hybrid; USD 112,000 - 151,000; Full time

Job summary

Amgen is seeking a Scientist/Senior Engineer for Commercial Drug Product to lead technical ownership for formulation, fill/finish, presentation, and lifecycle management of drug product SKUs. The role involves supporting tech transfers, process characterization, scale‑up, and continuous improvement across global sites and partners.

You will collaborate with Process Development, Manufacturing, Quality, Regulatory, and Supply Chain teams to ensure robust supply, regulatory compliance, and

Qualifications

• Doctorate degree OR Master’s degree and 4 years of Operations, Process Development, Scientific, or Engineering experience
• Bachelor’s degree and 6 years of Operations, Process Development, Scientific, or Engineering experience

Responsibilities

• Serve as the Drug Product SKU Lead for assigned commercial or late‑stage pipeline products, providing end‑to‑end technical ownership for formulation, fill/finish, presentation, and lifecycle management activities
• Lead or support commercial technology transfers, including facility‑fit assessments, make‑a‑batch assessments, process gap analyses, risk assessments, process characterization studies, technical documentation, and on‑site manufacturing support
• Provide technical leadership for parenteral drug product unit operations, including formulation, mixing, sterile filtration, filling, capping, lyophilization, visual inspection, and related equipment/process interfaces

Job description

Amgen is seeking a Scientist/Senior Engineer for Commercial Drug Product to lead technical ownership for formulation, fill/finish, presentation, and lifecycle management of drug product SKUs. The role involves supporting tech transfers, process characterization, scale‑up, and continuous improvement across global sites and partners.

You will collaborate with Process Development, Manufacturing, Quality, Regulatory, and Supply Chain teams to ensure robust supply, regulatory compliance, and