Principal Engineer
- Employer
- Amgen
- Location
- Cambridge, MA, US
- Start date
- Sep 23, 2020
View more
- Discipline
- Engineering, Process Engineer, Manufacturing & Production, Operations, Process
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Genetown, Best Places to Work
Job Details
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.
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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