Process Development Senior Scientist

Process Development Senior 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.

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.

Amgen’s Commercial Attribute Sciences group in Thousand Oaks, California is seeking a Principal Scientist. The successful candidate will join us on our effort to deliver innovative human therapeutics to patients worldwide by supporting Amgen’s marketed biologic products responsible for analytical leadership of large molecule commercial programs and patient impact expansion/lifecycle management activities. The role will involve close partnership with local and global Quality and will also involve representation of Attribute Sciences on global cross‑functional product teams that include partners such as Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC, and Supply Chain.

The successful candidate will actively chart the course translating product‑advancement business strategies into actionable scientific objectives and plans, routinely engaging with executive leadership on the communication of key developments. The successful candidate will also be given development opportunities to advance their own career in partnership with their manager.

• Lead analytical method lifecycle management activities including method remediation, improvements, and support method and validation and transfers
• Contribute to global regulatory filings by authoring analytical CMC sections and RTQs ensuring success of commercial approval and launch
• Independent authorship and review of technical reports, variations and responses to analytical questions from health authorities
• Provide analytical method subject matter expert leadership support of product quality and method‑related investigations including OOS/OOT and unexpected result root cause determinations
• Interface and collaborate with other functional areas in matrix environment, including team across various geographic locations in different time zones
• Duties may include establishing timelines, achievements, methodological approaches, expected results, necessary resources and communication to global cross‑functional team members
• Prepare clear written and verbal communications to key customers and senior leadership
• Implementing innovative and fit‑for‑purpose analytical methods for: release testing, stability testing, product characterization/optimization, investigations, and regulatory submissions, which may include laboratory activities
• Keeping current in the analytical development field including literature and technology development for cutting edge and regulatory driven activities
• Provide analytical leadership for post‑approval CMC LCM projects, facilitate and manage testing activities in support of process characterization, PPQ, and analytical comparability studies, develop derisk strategies, provide oversight to analytical results for regulatory submissions

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

• Doctorate degree PhD OR Pharm
  
  D [and relevant post‑doc where applicable]
• Master’s degree and 3 years of relevant experience
• Bachelor’s degree and 5 years of relevant experience