Senior Process Owner, GMP Manufacturing Programs

BioSpace

Holly Springs (NC)

On-site

USD 140,000 - 210,000

Full time

3 days ago

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Job summary

Amgen North Carolina seeks a Manager Manufacturing Programs Process Owner Team to lead a team of Process Owners in GMP drug substance manufacturing. The role encompasses technical process stewardship, floor support, and regulatory readiness, with collaboration across multiple functions.

The position emphasizes safety, quality, compliance, and continuous improvement, with accountability for CAPA, risk assessments, and change controls.

Qualifications

PhD or higher in biotechnology/pharmaceutical field, or equivalent.
Master's degree with 3+ years in biotech/pharma manufacturing.
Bachelor's degree with 5+ years in biotech/pharma manufacturing.
Associate's degree with 10+ years in biotech/pharma manufacturing.
High school/GED with 12+ years in biotech/pharma manufacturing.

Responsibilities

Lead and develop a team of Process Owners across GMP drug substance manufacturing.
Foster safety, quality, compliance, accountability, and continuous improvement.
Provide leadership for technical process stewardship and manufacturing support.
Ensure effective floor support, troubleshooting, and manufacturing execution assistance.
Oversee readiness activities like water runs, dry runs, and EBR testing.