Manager, Microbiology (CVRM)

Genentech•Holly Springs, NC

About The Position

Genentech is seeking an experienced leader to establish and head the QC Microbiology team at its Holly Springs, North Carolina facility. The role will build an engaged organization that delivers safe, compliant, and efficient testing for Cardiovascular, Renal, and Metabolism (CVRM) products. During laboratory start-up, the manager will establish core QC capabilities to support facility, utility, and process qualifications, then transition the team to routine commercial operations after site licensure. The manager will build a proactive quality and safety culture founded on psychological safety, transparent communication, personal accountability, Behavior-Based Safety, and Lean Leadership. The role also partners with the global network to harmonize QC standards, establish operational performance measures, and lead strategic projects supporting QC network strategy. The facility is a $2 billion greenfield investment with a planned launch in 2028 and focuses on high-volume drug product manufacturing using automation, robotics, digital tools, and real-time data analytics.

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 regulatory requirements, including FDA and EMA requirements.
Proven technical leadership capabilities and project management skills, including managing workload distribution, timelines, and competing priorities.
Exceptional communication skills and demonstrated ability to inspire, motivate, and coach a team.
Ability to collaborate effectively with internal cross-functional groups, global partners, suppliers, and external customers.
Proven 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, building capabilities for laboratory start-up and subsequent commercial operations.
Promote a proactive quality culture through psychological safety, transparent communication, personal accountability, and process simplification.
Foster a proactive safety culture through Behavior-Based Safety principles and compliance with site safety processes and regulatory standards.
Develop an engaged, high-performing laboratory culture through Lean Leadership, coaching, and continuous improvement.
Ensure appropriate staffing, resource allocation, and workload balancing in response to business priorities and operational demands.
Partner with the global network to harmonize QC standards and support compliant site operations.
Establish key operational performance indicators 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 Quality Management System 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 QC network strategy.
Present microbiology topics during regulatory inspections and maintain continuous audit readiness across QC operations.
Manage operational and capital budgets, supporting cost-efficient laboratory operations and resource optimization.