Sr. Principal Scientist

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Sr. Principal Scientist

Live

What you will do

Let’s do this! Let’s change the world!

Amgen is currently seeking a Process Development Senior Principal Scientist for our Commercial Drug Product Technologies Group located in Thousand Oaks, CA. This group is responsible for process development and lifecycle management of commercial drug product formulation and fill/finish processes across various modalities (synthetics, large molecule, siRNA, virus, etc.). The Senior Principal Scientist will provide technical and project leadership while integrating information generated by cross functional teams to ensure success through the commercialization and life-cycle of the products.

Responsibilities include:

• Serve as a leader on Drug Product Commercialization Teams responsible for planning, designing, executing, and documenting laboratory studies related to drug product design, formulation, and process development in support of commercialization and lifecycle management of both parenteral and oral solid dosage presentations.
• Lead a team of scientists focused on late-stage drug product process development and tech transfer and coach staff with emphasis on people-centered leadership.
• 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.
• Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering.
• Participate and lead global cross-functional teams working effectively in a highly matrixed team environment to influence and drive change, efficiency, and foster strong relationships.
• Author and review guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions.
• Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs.
• Actively utilize advanced IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis.
• Ability to travel domestically and internationally up to 10% of the time.

Win

What we expect of you

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.

Basic Qualifications:

• Bachelor’s degree and 8 years of Scientific experience OR
• Master’s degree and 6 years of Scientific experience OR
• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 3 years of Scientific experience

Preferred Qualifications:

• Advanced degree in Pharmaceutics, Biotechnology, Engineering, Material Science or related discipline
• 5+ years of post-doctoral or industry experience in pharmaceuticals/biotechnology or related field
• Knowledge of/hands-on experience with end-to-end development for liquid, lyophilized and/or oral solid dosage drug products in various presentations
• Knowledge and awareness of the regulations governing combination product development
• Experience with unit operation for both parenteral (i.e. filling, filtration, mixing, etc.) and oral solid dosage manufacturing (i.e. milling, granulation, blending, etc), specific scale-down model development, characterization, and scale-up
• Understanding of physical/chemical stability of proteins and how process related stress impacts product quality, specifically, the impact of freezing and drying to short- and long-term stability
• Aseptic processing experience and familiarity with cGMPs, ICH guidelines, and pre-approval inspection/audits
• Experience that includes elements of new product development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical proce