Sr Associate Mfg

The Amgen Thousand Oaks, Building 20 Drug Product Manufacturing facility 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 is responsible for maintaining the highest levels of safety, quality, compliance, and efficiency while balancing a dynamic production schedule. You will work cross-functionally to support multiple customers and stakeholders 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 and compliant culture by identifying preventative measures
• Creating and/or revising standard operating procedures
• Leading continuous improvement initiatives, which may be cross-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, but not limited to unit operations
• Monitoring productivity and identifying countermeasures for issues impacting cycle time adherence
• 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, 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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