Career Category
ManufacturingJob Description
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Senior Associate Manufacturing
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 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 partners including Supply Chain, Quality Assurance, Process Development, and Engineering.
The Senior Associate Manufacturing will be specifically responsible for:
Performing drug product filling and formulation activities, respectively
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 non-conformances (NC), Corrective/Preventative Actions (CAPA)
Serving as an On-the-job (OTJ) trainer for fellow staff members on the 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 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
Thrive
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Apply now for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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