Amgen

Principal Scientist DP AMA

Employer
Amgen
Location
Cambridge, MA, US
Posted
May 24, 2019
Ref
R-76980
Required Education
Doctorate/PHD/MD
Position Type
Full time
Amgen is currently seeking a Process Development Principal Scientist for our Pivotal Drug Product Technologies Group in Cambridge, MA. This group is responsible for late stage biologics drug product formulation and fill/finish process development. The Principal Scientist will provide technical and project leadership while integrating information generated by cross functional teams to ensure success through the commercialization process. Many of the technologies we're employing are not only new to Amgen but are new to the industry as a whole. Responsibilities include:
  • Partner with Amgen Thousand Oaks engineers to develop, characterize and implement state-of-the-art automated systems and technologies to support advancements in Drug Product formulation and process development.
  • Apply scientific and engineering principles (e.g. chemistry, fluid dynamics, statistics, modeling, etc.) to develop, characterize and implement automation, high throughput screening, formulation, process, and analytical technologies.
  • Utilize science-based critical thinking and advanced troubleshooting, as site SME for complex robotic automated visual inspection system and filling equipment.
  • Enable seamless integration of new technologies and innovation into existing workstreams through a user-focused design and development approach.
  • 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.
  • Manage a team of engineers/scientists to advance program and functional objectives
  • Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering.
  • Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs.
  • Participate and lead global cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships
  • Ability to travel domestically and internationally up to 20% of the time.


Basic Qualifications
  • Doctorate degree & 3 years of scientific experience
  • OR
  • Master's degree & 6 years of scientific experience
  • OR
  • Bachelor's degree & 8 years of scientific experience


Preferred Qualifications
  • Advanced degree in Engineering, Pharmaceutics, Biotechnology, Material Science or related discipline
  • 12+ years of post-Ph.D working experience that includes 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 experts with demonstrated results driving forward pipeline and lifecycle management programs bringing new biotech products to market, across various dosage forms and device delivery systems
  • Superior knowledge of formulation, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling, and the associated GMP/Device documentation and regulatory filings
  • Strong problem solving and effective cross-functional communication skills and ability to influence colleagues with ideas
  • Previous scientific and managerial experience in support of drug product development, investigations and regulatory filing is essential
  • Proven track record of publication, patents and presentations


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 leverages 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.