Senior Associate Manufacturing

What you will do

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 Supply 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 vital role you will work with a team responsible for supporting multiple Drug Product manufacturing operations, including 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 partners including Supply Chain, Quality Assurance, Process Development, and Engineering.

The Senior Associate Manufacturing will be specifically responsible for:

• Performing drug product filling activities
• Performing initial review of manufacturing batch records
• Maintaining a safe and compliant environment by identifying preventative measures
• Crafting and/or revising standard operating procedures
• Leading continuous improvement initiatives, which may be cross-functional in nature
• Performing data analysis 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 process steps
• Monitoring productivity and identifying countermeasures for issues impacting cycle time adherence
• Elevating critical and impactful events to management
• Using 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 Deviations, Corrective/Preventative Actions (CAPA)
• Serving as an On-the-job (OTJ) trainer for fellow staff members on the floor

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek is a collaborative partner with these qualifications.

Basic Qualifications:

• Master's degree OR
• Bachelor's degree + 6 months operations or quality work experience OR
• Associate's degree + 2 years operations or quality work experience OR
• High school Diploma/GED + 4 years operations or quality work 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 proven understanding of Lean concepts and application within a regulated manufacturing environment
• 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