28 days old

Sr Engineer

Amgen
Cambridge, MA 02138
  • Job Code
    134286340
  • Jobs Rated
    8th
Amgen

Job ID: R-116808
Location: Cambridge, MA, US

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.

SENIOR ENGINEER

Live

What you will do

Let's do this. Let's change the world. In this vital role you will join our Process Development organization, Global Manufacturing Sciences and Technologies provides regional expert technical support focused on delivering high quality product to patients through excellence in process support, process engineering and technology advancement and implementation. This position is located at our Cambridge, MA site.
  • The Senior Engineer provides process development technical support to solid and liquid oral drug products at Amgen contracted manufacturing sites, including process performance, implementation of process improvement strategies, and development of process models.
  • Leads and participates in formulation development and scale-up of oral solid and liquid dosage form formulations.
  • Works with oral solid dose processes such as granulation, roller compaction, blending, milling, drying, compression, and encapsulation.
  • The successful candidate will act as a drug product contract manufacturing and team leader to provide process leadership and solve process challenges across multiple unit operations. Provide process development expertise for commercial drug product processing in specific areas such as process characterization, tech transfer and validation.
  • Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA, process characterization, scale up, validation, and technology transfer.
  • Troubleshoot issues with drug product processing technologies and equipment; develop and characterize drug product processes and transfer technology to commercial drug product sites; conduct risk assessment for drug product operations and propose / implement appropriate CAPA; identify and implement operational opportunities for current and new sterile operations.

Responsibilities may also include leading cross-site teams to support the above activities, providing recommendations to management.

Travel (up to 25%) to domestic and/or to international contract manufacturing sites is expected.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The biotech/pharma engineering professional we seek is a collaborative team-player with these qualifications.

Basic Qualifications:

Doctorate Degree

Or

Master's Degree and 3 years of Engineering and/or Operations experience

Or

Bachelor's Degree and 5 years of Engineering and/or Operations experience

Or

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

Or

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

Preferred Qualifications:

  • M.S. in Science or Chemical Engineering
  • 6 + 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.
  • 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.
  • Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
  • Experience working with external contractors/suppliers with demonstrated use of interpersonal skills to build strong technical relationships.
  • Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
  • Experience providing leadership to cross-functional teams to advance complex projects to completion.
  • Experience with parental fill finish operations including drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation, for protein parenteral products.


Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits


Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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.





PI134286340

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Jobs Rated Reports for Software Engineer

Posted: 2021-04-17 Expires: 2021-05-18

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Cambridge, MA 02138

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