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Specialist Manufacturing

Employer
Amgen
Location
Thousand Oaks, CA, US
Start date
Sep 20, 2019

Job Details

This Specialist Manufacturing position is within Amgen Thousand Oaks Drug Substance Supply (Manufacturing) organization. This role is a key communication and technical interface between the GMP manufacturing teams in the plant and process development scientific groups. This Specialist position will be focused on upstream cell culture/harvest operations.

Job scope and responsibilities:
  • New Product Introduction lead coordinating with Supply Chain, Planning, Facilities and Engineering as well as Manufacturing to introduce new products and/or advanced technologies into the plant.
  • Technical expert who leads or participates in projects, ensuring that production documents are accurate and up to date.
  • Support Manufacturing in troubleshooting, problem solving and RCAs. Support CAPA development to prevent error recurrence.
  • Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level.
  • Collaborate with Regulatory and Quality partners to manage change control records and respond to regulatory questions and/or audit findings.
  • Generate electronic and paper process documents to assure plant success. Perform electronic batch record editing and troubleshooting to support production, as required.


Basic Qualifications:
Master's degree in chemistry, biology or engineering & 3 years of biotechnology operations experience
OR
Bachelor's degree & 5 years of biotechnology operations experience
OR
Associate's degree & 10 years of biotechnology operations experience
OR
High school diploma / GED & 12 years of biotechnology operations experience

Preferred Qualifications:
  • Degree in Chemical Engineering, Industrial Engineering or Biochemistry
  • Excellent technical writing skills and experience with electronic documentation systems
  • Experience with PAS X, Werum software with capability to create and edit in EBR
  • Experience in GMP operations
  • Strong technical knowledge of drug substance purification (chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing (cell culture, fermentation)
  • Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.
  • Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
  • Ability to coach, mentor and/or cross train colleagues within core technical areas
  • Background in lean manufacturing methodologies and operational excellence
  • Experience in cross functional Project Management


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.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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