Amgen

Specialist Manufacturing

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Sep 15, 2020
Ref
R-104014
Required Education
High School or equivalent
Position Type
Full time
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.

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 processing (cell culture, harvest, chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing
  • 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.

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.