Amgen

Senior Associate Manufacturing

Employer
Amgen
Location
West Greenwich, RI, US
Posted
Feb 17, 2019
Ref
R-71459
Required Education
Masters Degree/MBA
Position Type
Full time
Shift: C - rotating nights (7pm - 7am)

Under minimal supervision, the Senior Associate Manufacturing will perform operations in the Purification area per Standard Operating Procedures. Employee will perform and monitor critical processes (Chromatography, UF/DF, Viral inactivation/filtration, LFH Operations, WIP Lab operations, SIP and CIP), execute routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, NC/CAPA, and technical reports. Employee will provide technical leadership to the team per the direction of the Purification manager as well as perform complex troubleshooting. Additionally, the Senior Associate may identify, recommend, and implement improvements related to routine functions and participate on Cross-functional teams while representing the Purification Department.

Basic Qualifications:
  • Master's degree
  • OR
  • Bachelor's degree and 2 years of Manufacturing or Operations experience
  • OR
  • Associate's degree and 6 years of Manufacturing or Operations experience
  • OR
  • High school diploma / GED and 8 years of Manufacturing or Operations experience


Preferred Qualifications:
  • Knowledge of large scale Purification operations, chromatography, TFF, aseptic processing, etc
  • CFR and Regulatory knowledge
  • Mechanical ability/expertise
  • Knowledge of WIP lab equipment and computers, with LIMS access
  • Basic statistical mathematical skills
  • Ability to interpret and apply GMP knowledge
  • Understanding of analytical methods for manufacturing area
  • Ability to demonstrate technical writing capability with Trackwise access
  • Able to demonstrate project management skills and presentation skills
  • Independently collaborate with outside resources
  • Ability to understand, apply and evaluate basic chemistry, biology and physical principles
  • Basic troubleshooting skills on Purification equipment
  • Experience with Delta V, RD's
  • Experience with lab equipment/testing


Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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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