Manager, Microbiology (CVRM)
About The Position
Genentech is establishing a large-scale, highly automated drug product manufacturing facility in Holly Springs, North Carolina, with a planned launch in 2028. The facility will manufacture Cardiovascular, Renal, and Metabolism (CVRM) medicines, including next-generation metabolic medicines targeting obesity and Type 2 diabetes. The Manager, Microbiology will establish and lead the site’s QC Microbiology team, building an effective organization that delivers safe, compliant, and efficient testing. The initial focus is laboratory start-up and establishing core QC capabilities to support facility, utility, and process qualifications. The role will then transition to routine commercial operations following site licensure. The manager will shape a proactive quality and safety culture, develop an engaged, high-performing team, and partner with the global network to harmonize QC standards. The position also leads technical and operational activities, including performance measurement, documentation, QMS records, technology implementation, data-driven improvement, strategic projects, and audit readiness.
Requirements
- B.S. or M.S. degree in a science-related discipline.
- At least 5 years of experience in pharmaceutical or biopharmaceutical manufacturing.
- At least 3 years of direct QC operations experience at a finished drug product commercial manufacturing site.
- Extensive technical knowledge of microbiology methods, laboratory instrumentation, and analytical method validation, qualification, and transfer in the pharmaceutical or biopharmaceutical industry.
- Extensive experience with contamination control strategies and environmental and utility system monitoring.
- In-depth working knowledge of cGMP operations, ICH guidelines, and global Health Authority requirements, including FDA and EMA requirements.
- Technical leadership capabilities and project management skills, including managing workload distribution, timelines, and competing priorities.
- Strong communication skills and demonstrated ability to inspire, motivate, and coach a team and collaborate with cross-functional groups, global partners, suppliers, and external customers.
- Experience managing operational and capital budgets (OpEx/CapEx), driving cost-efficient laboratory operations, and optimizing resources.
Nice To Haves
- Experience in a greenfield project.
- Formal Operational Excellence certification, such as Lean Six Sigma Green/Black Belt, 5S, or Kaizen.
Responsibilities
- Establish and lead the QC Microbiology team and build capabilities for laboratory start-up, facility, utility, and process qualifications, and subsequent commercial operations.
- Promote psychological safety, transparent communication, personal accountability, and a proactive quality culture.
- Foster a proactive safety culture through Behavior-Based Safety principles and compliance with site safety processes and regulatory standards.
- Develop a high-performing lab culture through Lean Leadership, coaching, and continuous improvement.
- Manage staffing, resource allocation, and workload balancing to support business priorities and operational demands.
- Partner with the global network to harmonize QC standards and support compliant site operations.
- Establish operational KPIs focused on compliance, Right-First-Time execution, and continuous improvement.
- Author, review, and approve technical, scientific, and compliance documents, including test methods, validation protocols, and SOPs.
- Own QMS records, including investigations, deviations, CAPAs, and change controls.
- Identify, evaluate, and implement new technologies aligned with business objectives or regulatory requirements.
- Use data-driven decision-making to identify trends, mitigate risks, and improve operational performance.
- Lead strategic projects supporting QC network strategy.
- Present microbiology topics during regulatory inspections and maintain continuous audit readiness across QC operations.
- Manage operational and capital budgets and drive cost-efficient laboratory operations and resource optimization.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
