Process Development Principal Scientist

Join Amgens Mission of Serving Patients. At Amgen, you will help pioneer the world of biotech in fighting the world's toughest diseases. With a focus on Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year to deliver innovative medicines that improve lives.

In this vital role within the Attribute Sciences (AS) department of the Process Development (PD) organization, you will define the favorable quality characteristics of therapies and optimize advanced analytical tools to guide development. You will lead attribute and analytical aspects of pivotal clinical process development, contribute to late‑phase clinical programs, support cGMP manufacturing activities, author regulatory documents, and drive product characterization for process comparability studies.

• Lead all attribute and analytical aspects of a program in pivotal clinical process development while working cross‑functionally within a product development team.
• Define analytical control strategies and implement methodologies for development of late phase clinical programs, including analytical method development and optimization.
• Lead method transfer and support cGMP manufacturing activities at internal manufacturing and contract manufacturing and testing sites.
• Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Answer analytical and product quality questions from health authorities.
• Drive product characterization in support of process comparability studies, regulatory filings, regulatory questions, and reference standard qualification.
• Provide expertise and evaluate Amgens platform and analytical technologies to drive innovation and efficiency within Process Development.
• Help define strategies that improve the effectiveness and efficiency of the Attribute Sciences department.
• Maintain current knowledge in the analytical development field, including literature and technology development for cutting‑edge and regulatory‑driven activities, and apply this knowledge to the evaluation and development of new methodologies.
• Recognized as a scientific resource who can provide mentorship to junior staff.

We seek a scientific leader with proven analytical expertise, strong leadership, problem‑solving, and communication skills, and the ability to manage complex projects across cross‑functional teams.

Doctorate degree (PhD, PharmD, or MD) with relevant post‑doc experience and 3 years of discipline experience, OR Masters degree with 6 years of scientific experience, OR Bachelors degree with 8 years of scientific experience.

• PhD with 3+ years of industry experience.
• Strong understanding of small molecule analysis, including chromatographic and spectroscopic techniques, with emphasis on separation science, Process Analytical Technologies (PAT), structure elucidation, and solid‑state characterization.
• Knowledge of analytical method development and testing requirements for solid oral dosage support, including dissolution method development.
• Solid understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) and their application in a phase‑appropriate manner.
• Hands‑on experience in development, validation, transfer, and remediation of methods for in‑process, release, and stability testing.
• Knowledge of major Pharmacopeia and International Conference on Harmonisation (ICH) / Food & Drug Administration (FDA) guidance documents related to analytical method transfer and validation, impurities, genotoxic impurities, and early phase development.
• Experience in technical transfer for non‑GMP and GMP production and testing to external contract organizations.
• Ability to multitask and manage deliverables on complex projects against timelines.
• Strong leadership, problem‑solving, decision‑making, and communication skills with the ability to work cross‑functionally and globally within CMC teams to deliver results.
• Excellent technical writing skills and attention to detail in authoring methods, specifications, technical reports,…