Amgen

Process Development Principal Scientist

Employer
Amgen
Location
Cambridge, MA
Posted
Dec 07, 2021
Ref
R-132969
Required Education
Bachelors Degree
Position Type
Full time

HOW MIGHT YOU DEFY IMAGINATION?

If you feel likeyourepart of something bigger, its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing and delivering ever-better products that reachover 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Process Development Principal Scientist: Pivotal Drug Product Technologies

Live

What you will do

Lets do this. Lets change the world. In this vital group leader role for the Pivotal Drug Product Technologiesgroupyou will provide technical and project leadership while integrating information generated by multi-functional teams to ensure success throughthe commercialization process.

Responsibilities:

  • Oversight oflate stagebiologics 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.

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

  • Participate and lead global 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 INDAand 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.

  • Expand the utilization of 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

Basic Qualifications:

  • Doctorate degree and 3 years of scientific experienceOR
  • Masters degree and 6 years of scientific experience OR
  • Bachelors degree and 8 years of scientific experience

We are all different, yet we all use our unique contributions to serve patients. Thescientific professionalwe seek has the following 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.

  • Outstanding 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.

  • Ability to learn and act on dynamic information at a rapid pace.

  • Demonstrated track record of publication, patents and presentations.


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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.