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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.

Specialist Manufacturing- Cell Bank Manufacturing

This Specialist Manufacturing position is within Amgen Thousand Oaks Cell Bank Manufacturing organization. This role will have primary responsibility leading all aspects of the Cell Bank storage stability program with additional responsibilities supporting the cell bank manufacturing process.

Job scope and responsibilities:

• This role will lead all aspects of the cell bank storage stability program and ensure the cell bank team is set up for success. Testing of cell banks is completed by performing cell bank vial thaw and cell expansion passages.

• Requires strong scientific and technical understanding of mammalian cell culture processes with experience carrying out in GMP manufacturing or lab environment.

• Ability to work cross-functionally with partner organizations such as Quality, Process Development, Supply Chain, Facilities & Engineering and Manufacturing.

• Responsible for testing schedule and ensuring resources, equipment and raw materials have been coordinated.

• Perform review of historical and in process data, through use of data analysis tools required to support routine testing activities and troubleshooting or investigations.

• Own quality records such as change controls, CAPA’s or deviations may be required to support the storage stability program or the broader cell bank production facility.

• Draft documents such as SOPs, protocols, etc or own and revise procedures in support of operations.

• Experienced with MES and drafting, revising or making routine updates to parameter lists for electronic batch records in support of operations.

• Gain advanced user access to sample tracking and testing results software, LIMS, in support of cell bank storage stability program.

• Champion Operational Excellence (OE) initiatives for the department and provides updates to leadership as needed.

• Support Manufacturing in troubleshooting and investigations; conduct problem solving and RCAs; develop and own CAPAs or countermeasures to prevent recurrence.

• Represent cell bank operations during regulatory inspections and when responding to information requests.

• Technical authority who leads or participates in projects to introduce new products and/or technologies into the plant.

• Experience with project management and/or developing and leading business processes.

Basic Qualifications:

• Doctorate degree OR

• Master’s degree & 3 years of manufacturing and operations experience OR

• Bachelor’s degree & 5 years of manufacturing and operations experience OR

• Associate’s degree & 10 years of manufacturing and operations experience OR

• High school diploma / GED & 12 years of manufacturing and operations experience

Preferred Qualifications:

• Degree in Life Sciences or Engineering

• Experience in GMP Tech Support roles, GMP operations or QC lab environment

• Technical knowledge of mammalian cell culture processing and broad understanding of related disciplinary areas

• Ability to coordinate, analyze, and interpret technical data through trend analysis, forecasting, modeling, etc.

• Ability to communicate technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms

• Leadership experience and ability to coach, mentor and/or cross train colleagues within core technical areas

• Background in lean manufacturing methodologies and operational excellence

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, improve 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.

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