Process Development Principal Scientist

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas -- Oncology, Inflammation, General Medicine, and Rare Disease -- we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Our award‑winning culture is collaborative, innovative, and science‑based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

In this vital role you will join Amgen’s Attribute Sciences (AS) department within the Process Development (PD) organization. You will define the favorable quality characteristics of the therapies it produces and optimize state‑of‑the‑art analytical tools to guide that development. The Pivotal PD organization focuses on developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including synthetic medicines (oligonucleotides and small molecules).

In this vital role as an Attribute Sciences team lead and group lead you will provide strategic analytical leadership to teams developing commercial manufacturing processes for synthetic and hybrid molecules and collaborate closely with Drug Substance, Drug Product, and Product Quality colleagues.

• 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 evaluation of Amgen’s platform and analytical technologies, helping 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
• Serve as a scientific resource who can provide mentorship to junior staff

We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a leader with the following qualifications.

Doctorate degree PhD, PharmD, or MD (and relevant post‑doc where applicable) and 3 years of experience in the discipline and/or sub‑discipline.

OR

Masters degree and 6 years of scientific experience.

OR

Bachelors degree and 8 years of scientific experience.

• PhD with 3+ years of industry experience.
• Strong understanding of small molecule analysis, including chromatographic and spectroscopic techniques, with an emphasis toward separation science, Process Analytical Technologies (PAT) for process understanding and control, structure elucidation, and solid‑state characterization.
• Knowledge of…