28 days old

Principal Scientist

Cambridge, MA 02138
  • Job Code

Job ID: R-98612
Location: Cambridge, MA, US 02139

Amgen is currently seeking a Process Development Principal Scientist for our Cambridge, MA-based Commercial Drug Product Technologies Group. 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 Principal Scientist will provide technical and project leadership while integrating information generated by cross functional colleagues to ensure success through the commercialization and life-cycle of the products.

Responsibilities include:
  • Serving 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
  • Providing 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.
  • Driving continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering.
  • Participating and leading global teams working effectively in a highly matrixed collaborative setting to influence and motivate change, efficiency, and cultivate strong relationships.
  • Authoring and reviewing guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions.
  • Delivering progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs.
  • Actively utilizing advanced IS systems to improve drug product design through faster data availability, using historical information, analyzing large data sets, and statistical analysis.
  • Ability to travel domestically and internationally up to 10% of the time.

Basic Qualifications
  • Doctorate degree and 3 years experience
  • OR Masters degree and 6 years of experience
  • OR Bachelor's degree and 8 years of experience.

Preferred Qualifications
  • Advanced degree in Pharmaceutics, Biotechnology, Engineering, Material Science or related field of study.
  • 5+ years of post-doctoral or industry experience in pharmaceuticals/biotechnology
  • 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 process control (SPC), and statistical design and analysis of experiments
  • Strong problem solving and effective ability to successfully interact and communicate across many levels, settings and circumstances.
  • Demonstrated ability to learn and act on dynamic information at a rapid pace

We understand that to successfully sustain and grow as a global enterprise and deliver for patients we must ensure a diverse and inclusive work environment.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and initiates its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.



Posted: 2020-04-28 Expires: 2020-05-29

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Principal Scientist

Cambridge, MA 02138

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