Senior Manager, Cleaning Validation & Manufacturing Programs
BioSpace
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Benefits offered by this job
Job summary
Amgen North Carolina is seeking a Manufacturing Programs Senior Manager to lead cleaning validation for both the existing and new Biologics Drug Substance facilities. You will manage cross-functional teams, ensure regulatory compliance, and drive continual improvement across lifecycle phases.
The role requires strong project management, communication, and leadership skills, with a focus on inspection readiness, standard work, and staff development within a Lean/OE framework to boost site
Qualifications
- Doctorate/6+ years biotech ops experience (or equivalent).
- Ability to manage multi-site cleaning validation projects.
- Strong writing and regulatory documentation skills.
- GMP manufacturing and lean/OE experience preferred.
- Experience leading teams and cross-functional collaboration.
Responsibilities
- Lead cleaning validation deliverables across plants.
- Oversee team outputs for quality and regulatory compliance.
- Support troubleshooting, RCAs and CAPA development.
- Develop standard work, inspection readiness tools, and staff training.
- Advance Lean Transformation and OE initiatives for productivity.
Skills
Education
Job description
Amgen North Carolina is seeking a Manufacturing Programs Senior Manager to lead cleaning validation for both the existing and new Biologics Drug Substance facilities. You will manage cross-functional teams, ensure regulatory compliance, and drive continual improvement across lifecycle phases.
The role requires strong project management, communication, and leadership skills, with a focus on inspection readiness, standard work, and staff development within a Lean/OE framework to boost site
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