Principal Engineer

Do you want to help shape the future of biopharmaceutical manufacturing? Are you interested in working with a diverse product portfolio of life changing products in a dynamic working environment? Would you like to work with a highly motivated team of process science professionals to positively impact patients' lives?

Come join us!

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient.

We are seeking a Principal Engineer to join our Drug Substance and Technology Engineering team at our Cambridge, MA site.

The Principal Engineer will be responsible for the technology transfer and commercial support of biologics drug substance processes across the network, including both the Amgen manufacturing network and Contract Manufacturing Organizations. This is an opportunity to lead a group of engineers and scientists while using engineering principles to implement manufacturing processes in cGMP environments. Beyond the advancement of commercial and pipeline molecules, the position is expected to amulti-functional and multi-functional initiatives employing strategic approaches.

This role will have managerial responsibilities and the successful candidate will apply process engineering knowledge to support development including:

• Planning, prioritizing, and coordinating activities for a team of Process Development Engineers focused on tech transfer activities
• Collaborating with senior Process Development staff and interacting with manufacturing, external partners, quality assurance, regulatory, and validation departments re: developing requirements and recommendations for programs
• Conceiving plans and conducting investigations in areas of considerable scope and complexity for cell culture and purification of biologic drug substance
• Designing, executeing, implementing and directing engineering or process projects which significantly contribute to attaining high priority goals
• Utilizing strong written and verbal communication skills in technical writing and presentations

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

Preferred Qualifications

• Demonstrated ability to manage and lead teams; delivering results in a highly fluid, interactive matrixed environment inclusive of project/program management and coordinating the allocation of resources
• 8+ years experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing
• Experience in cell culture/purification process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale including cell expansion, harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration among others for a variety of biological molecules
• Experience working with commercial manufacture of biologics using single use technology
• Strong understanding of cGMP requirements, validation, regulatory filings, root cause investigations, and current industry practices
• Experienced in statistical process monitoring and principles of statistical analysis generated from a variety of analytical techniques
• Strong oral and verbal communication and presentation skills enabling strong relationships with internal and external partners
• Ability to derive insightful strategies to improve business processes; able to implement continuous improvement and Lean practices
• Fluency in foreign languages

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.