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Amgen Senior Engineer - Drug Substance Tech and Eng in Cambridge, Massachusetts

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? 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 have a position available for a Senior Engineer to join our Drug Substance and Technology Engineering team at our Cambridge site. The Sr. Engineer will be part of a team focused on technology transfer, scale-up, and resolving processing issues. The candidate is expected to provide clinical and commercial support of biologics drug substance processes across the network, including both the Amgen manufacturing network and/or Contract Manufacturing Organizations.

The successful candidate will apply process engineering knowledge to support development including:

  • Provide solutions to a variety of technical problems in cell culture and/or purification with increasing scope and complexity while applying standard engineering techniques and procedures

  • Conducting technical assessments on process/product impact due to changes in equipment, scale, and raw materials

  • Provide technical support and lead troubleshooting of clinical and commercial drug substance manufacturing while performing technical review of data, and authoring and reviewing GMP documentation

  • Keep current on the latest industrial, scientific and regulatory trends to assist in the review and authorship of relevant sections of global regulatory filings

  • Function as a technical expert on equipment and/or systems regarding process design, scale-up, and troubleshooting operations

  • Routinely monitor manufacturing processes for performance indicators and operations

  • Represent process development and interface with process development, manufacturing, external partners, quality assurance, regulatory, and validation departments in developing requirements and recommendations for processes and/or system modifications

  • Utilize strong written and verbal communication skills in technical writing and presentations

Basic Qualifications (Senior Engineer)

  • Doctorate degree and 0-2 years of directly related experienceOR

  • Master’s degree and 6+ years of directly related experienceOR

  • Bachelor’s degree and 8+ years of directly related experience

Preferred Qualifications (Senior Engineer)

  • Experience related to upstream (cell culture) / downstream (purification) process development/characterization, technology transfer, scale-up and manufacturing of biologics (cGMP)

  • Experience working with contract manufacturers

  • Possess advanced understanding of regulatory and cGMP requirements

  • Able to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements

  • Able to manage project resources and elevate relevant issues to project lead and line management

  • Able to build and maintain high-performing, cross-functional partnerships and to lead matrix teams to advance complex projects to completion

  • Demonstrated ability to work under minimal direction

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.​

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