Process Development Senior Scientist - Pivotal Drug Product Technologies

Amgen • Thousand Oaks, CA

285d • $127,764 - $152,656 • Hybrid

About The Position

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.

Requirements

• Doctorate degree PhD OR PharmD OR MD completed by May 2025.
• Master's degree and 3 years of scientific experience.
• Bachelor's degree and 5 years of scientific experience.

Nice To Haves

• Advanced degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutics or related discipline with experience in pharmaceutical development and manufacturing.
• 2+ years of post-doctoral or industry experience in pharmaceuticals/biotechnology or related field.
• Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up.
• Experience leveraging Artificial Intelligence (AI) and Generative AI (GenAI) tools to drive automation, enhance data analysis, optimize workflows, and develop AI-powered solutions for business and operational efficiency.
• Strong problem solving and effective cross-functional communication skills.
• Experience with data visualization tools or packages, such as Tableau or Spotfire.
• Experience that includes elements of new product development, formulation development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments.
• Proven ability to learn and act on dynamic information at a rapid pace.

Responsibilities

• Apply basic science/engineering skills and first principle modeling to solve technical problems.
• Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline products, as well as, supporting commercial products in lifecycle management.
• Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software.
• Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements.
• Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
• Deliver progress reports and presentations to ensure management awareness and engagement of the current status, advancement, and future program functional needs.
• Ability to travel domestically and internationally up to 10% of the time.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements, where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree