QC Microbiology Lead for Greenfield Pharma Start-up

Genentech, Inc.; Holly Springs (NC); Sur place; USD 100 000 - 185 000; Plein temps

Résumé du poste

Genentech, Inc. in Holly Springs, NC, is launching a state-of-the-art QC Microbiology team for CVRM products, starting with start-up activities and moving to commercial operations after licensure.

The role emphasizes proactive quality culture, safety, Lean Leadership, and collaboration with global partners to ensure compliant testing and audit readiness.

Ideal candidate holds BS/MS in science with 5+ years in pharma, strong microbiology expertise, and proven leadership of budgets and teams.

Qualifications

• Minimum 5 years in pharma/biopharma manufacturing with 3+ years in QC operations at a finished drug product site.
• Deep knowledge of Microbiology methods, instrumentation, validation, and transfer.
• Experience with cGMP, ICH guidelines, and global health authority requirements.

Responsabilités

• Establish and lead the QC Microbiology team to deliver compliant testing for CVRM products.
• Build core QC capabilities during start-up before routine site operations.
• Develop KPIs, manage QMS records, deviations, CAPAs, and change controls.
• Collaborate with global network to harmonize QC standards and regulatory readiness.

Connaissances

Technical leadership

Project management

Communication skills

Budget management

Formation

B.S./M.S. in Science

Description du poste

Genentech, Inc. in Holly Springs, NC, is launching a state-of-the-art QC Microbiology team for CVRM products, starting with start-up activities and moving to commercial operations after licensure.

The role emphasizes proactive quality culture, safety, Lean Leadership, and collaboration with global partners to ensure compliant testing and audit readiness.

Ideal candidate holds BS/MS in science with 5+ years in pharma, strong microbiology expertise, and proven leadership of budgets and teams.