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Specialist Manufacturing - Downstream DS at Amgen - ApplyBlast

Specialist Manufacturing - Downstream DS

Amgen

4 months ago

3.6 on Glassdoor

California

Hybrid

Full Time

Senior

0 applicants

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About this role

As a Specialist Manufacturing Associate at Amgen, you will support manufacturing activities through new technology introduction, continual improvement projects, and process optimization within the drug substance supply organization. You will execute production changes, lead corrective actions, and manage validation documentation while ensuring strict adherence to GMP compliance and safety standards. This role involves some hands-on work on the plant floor, designing experiments, and mentoring junior staff to drive operational efficiency.

Responsibilities

Support drug substance downstream manufacturing as process owner
Lead cross-functional complex projects utilizing project management skills
Resolve issues and optimize processes through troubleshooting and testing
Write and maintain protocols for validation and equipment qualification
Own quality records including CAPA and deviation trending

Skills

Qualifications

Doctorate DegreeMaster's Degree in Engineering or Life SciencesBachelor's Degree with 4 years experienceAssociate's Degree with 8 years experienceHigh School Diploma with 10 years experience

About Amgen

amgen.com

Headquarters

Thousand Oaks, California, United States

Company Size

10001+ employees

Founded

1980

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Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.