Amgen

Sr. Associate Mfg.

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Feb 14, 2019
Ref
R-71266
Required Education
Masters Degree/MBA
Position Type
Full time
This Cell Culture Manufacturing Senior Associate position will support the re-commissioning and start-up of commercial cell culture drug substance intermediate manufacturing operations in Thousand Oaks, CA. The Sr. Associate will coordinate and lead production operations on the manufacturing. This role is a key communication and technical interface between the GMP manufacturing teams in the plant and our partner organizations.

Job scope and responsibilities:
  • Lead manufacturing operations on the production floor.
  • Ensure all safety and compliance procedures are followed at all times.
  • Participate in the development, execution, and issue resolution associated with process equipment Commissioning, Qualification and Validation.
  • Provide troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor.
  • Write, revise, and own controlled documentation (SOPs, Manufacturing Procedures (MPs), Forms, Technical Reports, etc.)
  • Serve as SME for Cell Culture operations including cleanroom Aseptic Technique.
  • Provide training to manufacturing staff on process and equipment.
  • Own Non-Conformances (NC) and Corrective and Preventive Actions (CAPA)
  • Champion Lean Transformation and OE initiatives, facilitate the drive towards continuous improvement in the plant, and track progress on a plant level.
  • Collaborate with Quality, Engineering, Process Development, Validation, and Operations to resolve manufacturing events in a timely manner.
  • Assure appropriate escalation to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.
  • Collaborate with Quality, Mfg. Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional teams.
  • Apply advanced process, scientific, operational, and compliance knowledge with analytical and troubleshooting skills to support manufacturing operations.
  • Participate in the design, development, and implementation of processes in support of the manufacturing floor.


Basic Qualifications:

Master's degree

OR

Bachelor's degree and 2 years of biotech or pharmaceutical manufacturing, process development or quality experience

OR

Associate's degree and 6 years of biotech or pharmaceutical manufacturing, process development or quality experience

OR

High school diploma / GED and 8 years of biotech or pharmaceutical manufacturing, process development or quality experience

Preferred Qualifications:
  • Degree in Chemical Engineering, Industrial Engineering or Life Sciences
  • Technical understanding of drug substance intermediate (Cell Culture) operations
  • Experience with Current Good Manufacturing Practices (cGMP)
  • Ability to be flexible and manage change
  • Experience participating in and leading cross-functional teams
  • Experience in managing multiple, competing priorities in a fast-paced environment
  • Strong scientific, technical interactions with partner organizations such as PD and F&E.
  • Experience in GMP Tech Support roles, GMP operations, process development or scheduling.
  • Experience with execution of Commissioning and Qualification, New Product Introduction, Cleaning Validation, and Process Performance
  • Experience with aseptic operations in Grade 5 (Class 100) cleanrooms.
  • Technical knowledge of Upstream Drug Substance Intermediate processing and broad understanding of related disciplinary areas - Bioreactors, Roller Bottles, UFDF.
  • Ability to organize, analyze, and interpret technical data through trend analysis, forecasting, modeling, etc. with excellent technical writing ability to convey processing events and conclusions
  • Background in lean manufacturing methodologies and operational excellence
  • Expertise in electronic systems used in manufacturing (MES/Werum, LIMS, Maximo, CCMS, etc.)


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.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

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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