Amgen

Process Development Product Senior Engineer

Employer
Amgen
Location
Cambridge, MA, US
Posted
Oct 18, 2020
Ref
R-104327
Required Education
Bachelors Degree
Position Type
Full time
Amgen is seeking a Process Development Product Senior Engineer to work with our contract manufacturing organizations across the world and resolve challenges encountered in commercial production of oral solid drug products.

This role will be based out of Amgen Massachusetts, as part of the global Process Development organization and will support new product introductions, lifecycle changes and ongoing commercial production.

International travel to visit contract manufacturing partner sites.

Responsibilities:
  • Act as a drug product technical expert, to provide leadership and solutions when troubleshooting oral solid drug product manufacturing, for all unit operations including but not limited to encapsulation, blending, milling, granulation, drying, compaction and coating.
  • Build excellent business relationships with Contract Manufacturing partners, Global Operations, Contract Manufacturing Quality, and Drug Product process teams.
  • Demonstrate the ability to lead, via cross-site teams, and in general by setting the agenda and identifying potential issues.
  • Provide process development expertise for commercial drug product processing in specific areas such process characterization, technology transfer, process validation and routine commercial production.
  • Troubleshoot issues with drug product processing technologies and equipment.
  • Identify and implement operational opportunities for current and new processes.
  • Support commercial drug product manufacturing operations and contract manufacturing quality with technical evaluation of NC/CAPA.
  • Visit contract manufacturing sites to support key production milestones and build relationships.


Basic Qualifications:

Doctorate degree
OR
Master's degree and 2 years of pharmaceutical manufacturing experience
OR
Bachelor's degree and 4 years of pharmaceutical manufacturing experience
OR
Associate's degree and 10 years of pharmaceutical manufacturing experience
OR
High school diploma / GED and 12 years of pharmaceutical manufacturing experience

Preferred Qualifications:
  • Masters or PhD in Science or Engineering
  • 5+ years of experience in Process Characterization, Technical Transfer (to commercial drug product sites), and Process Validation of oral solid drug products.
  • Strong skills in applying fundamental engineering and scientific principles to the design and implementation of wet granulation, roller compaction, blending, milling, drying, compression, coating and encapsulation processes.
  • Project management skills including the ability to manage multiple projects and evaluate project resources.
  • Strong knowledge of quality and regulatory systems, drug product manufacturing and process validation.
  • Experience managing and building strong relationships with contract manufacturing organizations.
  • Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.
  • Knowledge of cGMP's and other worldwide regulatory requirements.
  • Pharmaceutical manufacturing experience in oral solid drug products.
  • Proven problem-solving ability and cross-functional collaboration.
  • Excellent oral and written communications skills.


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.

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.