Process Development Senior 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.

Process Development Senior Principal Scientist

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What you will do

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

In this vital group leader role for the Pivotal Biologics, Drug Product Technologies group you will provide technical and project leadership while integrating information generated by multi-functional teams to ensure success through the commercialization process. A key, and differentiating, responsibility of this role will be partnering with the DPT platform lead to progress the drug product platform, in addition to supporting pipeline program development.

• Oversight of late-stage biologics drug product formulation and fill/finish process development.

• Lead cross-functional Drug Product Commercialization Teams responsible for formulation development, fill/finish process development / characterization, technology transfer and regulatory authoring for pipeline and lifecycle management projects.

• Lead all aspects of and engage in the planning, design, execution, and documentation of formulation and fill/finish process development studies.

• Lead maintenance and expansion (as needed) of the core product-enabling platform knowledge assets that enable our product teams to deliver high-quality data packages and advance products through commercialization milestones.

• Collaborate with DPTLs, unit op owners and process engineers to ensure platforms are serving the needs of product teams.

• Provide guidance, feedback, and best practices to product teams on how to leverage the platform capabilities.

• Ensure platforms and regulatory strategies maintain alignment, collaborating with UOOs and SME reviewers to close any gaps.

• Measure performance of portfolio against platform targets and draw insights from fit to platform assessments and identify actions required.

• Manage a team of engineers and scientists to advance program and functional objectives.

• Participate and lead cross-functional teams working effectively in a highly matrixed team environment to motivate change, efficiency and strong relationships.

• Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of INDA and marketing application submissions.

• Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering.

• Serve as subject matter expert in drug product technologies and help drive best practices and technical advancements.

• Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, strategy and future program and functional needs.

• Ability to travel domestically and internationally up to 10% of the time.

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What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek has 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 Engineering, Pharmaceutics, Biotechnology or Material Science.

• 10+ years of post-PhD experience including elements of formulation and fill/finish process development, process characterization, technical transfers to manufacturing sites, and statistical design and analysis of experiments, and regulatory authoring.

• Leadership of highly technical professionals with demonstrated results driving forward pipeline and lifecycle management programs.

• Hands-on experience bringing new biotech products to market, across various dosage forms and device delivery systems.

• Experience with advanced drug delivery for biologics including sustained release, nasal, pulmonary, or dermal delivery.

• Out