Process Development Sr Scientist

Process Development Sr 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 to 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’s focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including (but not limited to) synthetic medicines, monoclonal and bispecific antibodies, bispecific T‑cell engagers, and live oncolytic viruses.

Located at our Thousand Oaks, CA office, the PD Senior Scientist will work to provide strategic analytical leadership (as an Attribute Sciences team lead) to teams developing commercializable manufacturing processes and collaborate closely with Drug Substance and Drug Product colleagues.

• Supervise and provide technical support for a team that provides analytical support for late‑stage product development
• Act as an Attribute Sciences Team lead for a program in pivotal clinical process development, being responsible for all analytical work to support the program
• Define the analytical target profile (ATP) for methods used to monitor product quality. Based on the ATP, oversee the development, qualification, remediation, and transfer of analytical methods to Quality Control
• Manage activities at 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 to define strategies that improve the effectiveness and efficiency of the Attribute Sciences department

The scientist professional we seek is an individual with these qualifications.

• Doctorate degree
• Master’s degree and 2 years of directly related life science experience
• Bachelor’s degree and 4 years of directly related life science experience
• Associate’s degree and 8 years of directly related life science experience
• High school diploma / GED and 10 years of directly related life science experience

• Doctorate degree with 5–7+ years in Analytical Chemistry, Biochemistry or equivalent.
• Relevant experience working as part of a multidisciplinary team in a biopharmaceutical setting would also be an advantage.
• Strong background in bioanalytical research and development focusing on method development to study proteins and peptides using novel separation techniques.
• Proficient in other HPLC and CE methods such as reversed‑phased HPLC, size‑exclusion HPLC, ion‑exchange HPLC, affinity HPLC, CE‑SDS, and cIEF
• Demonstrate knowledge of regulatory…