Amgen

Principal Engineer

Employer
Amgen
Location
Cambridge, MA, US
Posted
Sep 08, 2019
Ref
R-80964
Required Education
High School or equivalent
Position Type
Full time

Overview:

Reporting to the Director of Process Development, this role will be based in Amgen's Cambridge- Massachusetts, or alternatively in Amgen's, Thousand Oaks-California offices. The successful candidate will lead Amgen's synthetics/oral dosage technical support. The scope of the role is to build and lead a team of 3-5 subject matter experts (SME's) supporting the technology transfer and production of Amgen's synthetic oral dosage forms. The team supports new product introductions, lifecycle changes and ongoing commercial production and development. Up to 30% US or international travel may be required to support Amgen's drug product network.

As part of the team that also supports Amgen's external parenteral biologics contract manufacturing network, this role also provides the opportunity for an individual to broaden their knowledge beyond oral solid dosage forms.
 

  • Provide technical and management leadership to a cross functional team of engineers and scientists.
  • Act as a drug product technical expert, to provide leadership and solutions when troubleshooting synthetic drug product manufacturing, for all processing stages such as blending, sieving, roller compaction, encapsulation, compression, coating etc.
  • Act as the accountable point of contact from the process development organization for product/process support for technology transfers and ongoing clinical and commercial drug product manufacturing at assigned contract manufacturing sites.
  • Build excellent business relationships with contract manufacturing partners, Global Operations, Contract Manufacturing Quality, and drug product process teams.
  • Lead functional and cross functional teams by setting the agenda, identifying issues and driving to goal completions and target dates.
  • Troubleshoot issues with drug product processing technologies and equipment.
  • Escalate issues, recommendations, and/or unresolved decisions in a professional and timely manner to the appropriate governance.
  • Holds others responsible or answerable for their actions, for exemplary job performance, and achieving business results.
  • Visit manufacturing sites to support key production milestones and build relationships

 


Basic Qualifications:

Doctorate degree and 2 years of Engineering or Operations experience

OR

Master's degree and 6 years of Engineering or Operations experience

OR

Bachelor's degree and 8 years of Engineering or Operations experience

OR

Associate's degree and 10 years of Engineering or Operations experience

OR

High school diploma / GED and 12 years of Engineering or Operations experience

Preferred Qualifications:

 

 

  • M.S. in Science or Chemical Engineering
  • 10 + years of experience in support of commercial oral solid and liquid Drug Product (DP) processing in specific areas such as Process Characterization, Tech Transfer (to commercial DP sites) or Validation
  • Experience with parental fill finish operations including drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation, for protein parenteral products
  • Strong skills in applying fundamental engineering and scientific principles to the design and implementation of granulation, roller compaction, blending, milling, drying, compression, and encapsulation processes
  • Candidate with synthetic/oral dosage experience who can branch into leadership in the parenteral area, consideration will also be given to candidates with parenteral experience who demonstrate they are capable of leading and growing in the synthetic/oral dosage area

 


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.

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.