Manager, Microbiology (CVRM)

Genentech, Inc.; Holly Springs (MS); Presencial; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

Genentech, Inc. in Holly Springs, NC is assembling a high-impact QC Microbiology leadership role to establish and head our QC Microbiology team.

You will build a focused, high-performing organization to deliver safe and compliant testing for CVRM products while standing up core QC capabilities to support facility qualifications and eventual steady-state operations. The role demands strong microbiology expertise, proven leadership, and a track record of cGMP compliance.

Formación

• Minimum 5 years of experience in pharmaceutical or biopharmaceutical manufacturing.
• At least 3 years of direct QC operations experience at a finished drug product commercial site.
• Strong knowledge of microbiology methods, laboratory instrumentation, and validation/transfer protocols.

Responsabilidades

• Establish and head the QC Microbiology team for Holly Springs site.
• Deliver safe, compliant, and efficient testing for CVRM products.
• Lead start-up activities and then support routine commercial operations post-licensure.
• Foster a proactive quality culture and drive continuous improvement across QC operations.

Conocimientos

Leadership

Project management

Communication

Data-driven decision making

Lean Leadership

Educación

B.S./M.S. in Science

Descripción del empleo

Welcome to Holly Springs, North Carolina- home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing.

The facility's core is defined by Innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant meets today's demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes. This is a fast-paced, entrepreneurial environment with a high-level of accountability, with planned launch in 2028.

Are you a problem-solver and change-agent who thrives in a Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to launch a state-of-the-art facility from the ground-up and shape the culture of our organization for the next generation.

Join us in Holly Springs, where you won't just build a plant-you will build the future of medicine.

The Opportunity:

The Holly Springs Quality Control Team is seeking an experienced and dynamic leader to establish and head our QC Microbiology team.

In this critical role, you will build a highly effective and engaged organization capable of delivering safe, compliant, and efficient testing for our CVRM (Cardiovascular, Renal, and Metabolism) products manufactured at the Holly Springs site. Initially, you will focus on laboratory start-up activities-establishing core QC capabilities to support facility, utility, and process qualifications-before pivoting to routine commercial operations following site licensure.

Leadership:

• You will champion a proactive quality culture built on psychological safety and transparent communication-empowering your team to speak up, simplify processes, and take personal accountability for owning quality.
• You will drive a proactive safety culture by fostering Behavior-Based Safety (BBS) principles and ensuring strict compliance with site safety processes and regulatory standards.
• You will foster a high-performing, engaged lab culture by practicing Lean Leadership, providing active coaching, and embedding continuous improvement into daily operations.
• You will ensure appropriate staffing, resource allocation, and workload balancing to support business priorities and changing operational demands.
• You will partner with the global network to harmonize QC standards and ensure seamless execution and compliance across site operations.

Technical and functional tasks:

• You will establish key operational performance measures (KPIs) with a focus on Compliance, Right-First-Time (RFT) execution and continuous improvement to meet business objectives.
• You will author, review, and approve critical technical, scientific, and compliance documents (e.g., test methods, validation protocols, SOPs).
• You will own Quality Management System (QMS) records, including investigations, deviations, CAPAs, and change controls.
• You will participate in the identification, evaluation, and implementation of new technologies in alignment with business objectives or regulatory requirements.
• You will use data-driven decision making to identify trends, mitigate risks, and improve operational performance.
• You will have responsibility for strategic projects to support execution of QC network strategy.
• You are experienced in presenting Microbiology topics during regulatory inspections and maintaining a continuous state of audit readiness across QC operations.

Who you are:

• You hold a B.S. or M.S. degree (Science related discipline) with a minimum of 5 years of experience in pharmaceutical or biopharmaceutical manufacturing. This includes at least 3 years of direct experience in QC operations at a finished drug product commercial manufacturing site.
• You have extensive technical knowledge of Microbiology methods, laboratory instrumentation, and analytical method validation, qualification, and transfer within the pharmaceutical or biopharmaceutical industry.
• You have extensive experience in contamination control strategies, environmental and utility system monitoring.
• You have in-depth working knowledge of cGMP operations, ICH guidelines, and global Health Authority regulatory requirements (FDA, EMA, etc.).
• You have proven technical leadership capabilities and demonstrated project management skills, with a track record of effectively managing workload distribution, timelines, and competing priorities.
• You have exceptional communication skills with the demonstrated ability to inspire, motivate, and coach a team while collaborating effectively with internal cross-functional groups, global partners, suppliers, and external customers.
• You have proven experienc