Manager, Microbiology (CVRM)
About The Position
Genentech is establishing a large-scale drug product manufacturing facility in Holly Springs, North Carolina, planned to launch in 2028. The facility will manufacture Cardiovascular, Renal, and Metabolism (CVRM) medicines using advanced automation, robotics, digital tools, real-time data analytics, and streamlined processes. The Manager, Microbiology will establish and lead the site's QC Microbiology team. The role is responsible for building an engaged organization capable of delivering safe, compliant, and efficient testing for CVRM products. Initially, the focus will be on laboratory start-up and establishing QC capabilities that support facility, utility, and process qualifications. Following site licensure, the role will transition to supporting routine commercial operations. The manager will promote psychological safety, transparent communication, personal accountability, and a proactive safety and quality culture. The role includes leading and coaching the team, managing staffing and resources, harmonizing QC standards with the global network, overseeing technical and compliance documentation and QMS records, applying data-driven approaches to improve performance, and supporting strategic QC network projects. The manager will also represent Microbiology topics during regulatory inspections and maintain 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 experience in QC operations 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 demonstrated project management skills, including management of workload distribution, timelines, and competing priorities.
- Exceptional communication skills and ability to inspire, motivate, and coach a team while collaborating with cross-functional groups, global partners, suppliers, and external customers.
- Experience managing operational and capital budgets (OpEx/CapEx), including driving cost-efficient laboratory operations and resource optimization.
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, building capabilities for laboratory start-up and subsequent routine commercial operations.
- Champion a proactive quality culture based on psychological safety, transparent communication, personal accountability, and process simplification.
- Foster a proactive safety culture by promoting Behavior-Based Safety principles and compliance with site safety processes and regulatory standards.
- Develop a high-performing lab culture through Lean Leadership, active coaching, and continuous improvement.
- Ensure appropriate staffing, resource allocation, and workload balancing to meet business priorities and operational demands.
- Partner with the global network to harmonize QC standards and support consistent, compliant site execution.
- 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 execution of the QC network strategy.
- Present Microbiology topics during regulatory inspections and maintain continuous audit readiness across QC operations.
Benefits
- A discretionary annual bonus may be available based on individual and Company performance.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
