Process Development Senior Scientist

Join Amgen's mission of serving patients

At Amgen, if you feel like you are 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 have helped pioneer the world of biotech in our fight against the world's toughest diseases. With a focus on 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 lie within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

We are seeking a Senior Scientist to join our Commercial Attribute Sciences group in Thousand Oaks, California. The successful candidate will support Amgen's marketed biologic products, providing analytical leadership of large molecule commercial programs and patient impact expansion/lifecycle management activities. The role involves close partnership with local and global Quality and representation on global cross‑functional product teams, including Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC, and Supply Chain.

You will translate product‑advancement business strategies into actionable scientific objectives and plans, engaging with executive leadership on key developments. Development opportunities to advance your career will be provided in partnership with your manager.

• Lead analytical method lifecycle management activities including method remediation, improvements, and support for method 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 for product quality and method‑related investigations, including OOS/OOT and unexpected result root‑cause determinations.
• Interface and collaborate with other functional areas in a matrix environment, including teams across various geographic locations and time zones.
• Establish 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.
• Implement innovative and fit‑for‑purpose analytical methods for release testing, stability testing, product characterization/optimization, investigations, and regulatory submissions, which may include laboratory activities.
• Keep 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 de‑risk strategies, and 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 the following qualifications.

• Doctorate degree (PhD or Pharm
  
  D) and relevant post‑doc where applicable, OR
• Masters degree and 3 years of relevant experience, OR
• Bachelors degree and 5 years of relevant experience.

• Advanced degree in Bioanalytical Chemistry, Analytical Chemistry, Biochemistry, Biochemical or Chemical Engineering.
• 3+ years pharmaceutical/biotech experience in process development and analytical method development.
• Deep understanding of product quality attributes and control strategies,…