Amgen

Sr Associate Mfg

Employer
Amgen
Location
Thousand Oaks, CA
Posted
Feb 11, 2019
Ref
R-64202
Required Education
Masters Degree/MBA
Position Type
Full time
This Purification Manufacturing Senior Associate position will coordinate and lead production operations on the manufacturing floor including taking a lead role in the qualification of process equipment, supporting development, clinical, and launch activities. 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 include:
  • 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 Purification 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 & 2 years of operations or quality experience

OR

Associate's degree & 6 years of operations or quality experience

OR

High school diploma / GED & 8 years of operations or quality experience

Preferred Qualifications:
  • At least 5 years of biopharmaceutical experience, with 3+ years of experience directly within drug product manufacturing, which includes aseptic and sterile filling environments, as well as lyophilization
  • Bachelor's or Master's degree in Microbiology, Life Sciences, Business or a related field
  • Strong working knowledge of Lean concepts and application within a regulated manufacturing environment
  • Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality
  • Basic project management skills
  • Demonstrates emergent leadership traits and strong cognitive problem solving skills


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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