Amgen

Production Process Owner

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Feb 12, 2019
Ref
R-71118
Required Education
Masters Degree/MBA
Position Type
Full time
Job Summary

The Senior Associate Manufacturing, Production Process Owner (PPO), position presents an opportunity for the qualified candidate to merge their leadership skills, technical knowledge of the operation, and general project management skills in support of Operational Excellence (OE). Under general supervision, the PPO responsibilities may include:
  • Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
  • Proactively monitor and draw conclusions around operational performance, which may include the utilization of PI.
  • Participate on and/or lead cross-functional project teams.
  • Identify, recommend, and implement improvements related to operations for the area.
  • Support the development of new strategies related to operations for the area (e.g., Validation strategies, SOP revision strategies, etc.).
  • Serve as a document owner. Initiate, review, revise, and approve manufacturing procedures and SOPs. Ensure all procedures reflect current operations.
  • Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
  • Provide troubleshooting support or may lead trouble shooting of production process operations.
  • Provide training and related materials on procedural, operational and technical aspects of the process.
  • Participate in the design and implementation of critical processes and/or facilities.
  • Comply with and reinforce cGMPs and safety requirements
  • May interact with representatives of regulatory agencies.
  • Review and provide input to regulatory submissions.
  • Provide manufacturing assessment of a proposed change.


Basic Qualifications:

Master's Degree

OR

Bachelor's Degree and 2 years of Manufacturing & Operations experience

OR

Associate's degree and 6 years of Manufacturing & Operations experience

OR

High school diploma/GED and 8 years of Manufacturing & Operations experience

Preferred Qualifications:
  • Experience with investigations into manufacturing deviations and determination of potential manufacturing impact and root cause, and application of corrective actions.
  • Experience interacting with representatives of regulatory agencies.
  • Experience and working knowledge of quality systems including change control process
  • Experience participating in and helping to lead cross-functional teams.
  • Experience in managing multiple, competing priorities in a fast-paced environment.
  • Strong technical writing and presentation skills.
  • Project management experience.
  • Detailed technical understanding of bioprocessing unit operations.
  • Skilled in performance of GMP production operations.
  • Ability to communicate and collaborate with technical and management staff.
  • In general, this individual will work a Monday through Friday day shift but may be required to support manufacturing floor operations during off-business hours.


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.

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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