20 days old

Sr Associate Manufacturing

Amgen
Thousand Oaks, CA 91360
  • Job Code
    123428931
Amgen

Job ID: R-104079
Location: Thousand Oaks, CA, US 91360

The Amgen, Pharma Product Manufacturing facility, in Thousand Oaks, directly supports Amgen's pipeline of clinical drug product supply to patients across the globe. The Sr. Associate Manufacturing - Drug Product role offers the opportunity to collaborate with multiple functions within the Thousand Oaks site on a routine basis in a dynamic environment (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering, etc.) while developing a deep understanding of the manufacturing operations and planning activities within the facility!

In this role, you will work with a team responsible for supporting multiple Drug Product manufacturing operations, including formulation, sterile-isolator filling, aseptic filling, and lyophilization activities. The team leads the efforts of maintaining the highest levels of safety, quality, compliance, and efficiency while balancing a dynamic production schedule. The Associate will work to support multiple internal customers and partners including Supply Chain, Quality Assurance, Process Development, and Engineering.

The Senior Associate Manufacturing will be specifically responsible for:

  • Executing drug product filling and formulation activities, respectively
  • Performing initial review of manufacturing batch records
  • Maintaining a safe environment while adhering to compliance standards and by identifying additional preventative measures
  • Crafting and/or revising standard procedures
  • Leading continuous improvement initiatives, which may be multi-functional in nature
  • Performing data analysis (e.g., SPC, CPV) of critical process parameters and making recommendations to Engineering and/or Process Development teams
  • Developing finite schedule for tasks including, unit operations
  • Reviewing efficiency and identifying countermeasures for issues impacting cycle time alignment
  • Elevating critical and impactful events to management
  • Utilizing appropriate systems for job duties (SAP, QMTS, and LIMS etc.)
  • Supporting the introduction of new products and technologies into the facility
  • Initiating and owning quality records, including but not limited to non-conformances (NC), Corrective/Preventative Actions (CAPA)


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, including work within drug or pharmaceutical product manufacturing environment, 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
  • An understanding of Lean concepts and application within a regulated manufacturing environment
  • Ability to communicate and collaborate with technical and management staff within the manufacturing, quality and process teams
  • Basic project management skills
  • Demonstrates emergent leadership traits and strong cognitive resolution abilities


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.



PI123428931
Posted: 2020-09-09 Expires: 2020-10-10

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Sr Associate Manufacturing

Amgen
Thousand Oaks, CA 91360

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