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.
Your Opportunity:
We are seeking a QC Principal Specialist, Microbiology to support the establishment of the Microbiology Laboratory at our Greenfield Holly Springs facility. During the site start-up phase, this role will be key to the development of the microbiology laboratory quality system, test method implementation, laboratory operations, and establishment of Contract Laboratory Operations (CLO) . You will design efficient microbiology operations through the integration of simplified processes, high level of automation/digital solutions and Rapid Micro technology. You will be a key partner to Operations and Quality in establishing an efficient, robust, and compliant Environmental and Utility monitoring program.
As the site transitions into routine operations the role will evolve into routine microbiology laboratory duties with full ownership of EM and Utility reports, a key Microbiology SME for the site and represent Holly Springs in the global microbiology forums.
You will be the QC Micro lead on the environmental monitoring program strategy, risk assessment, sampling, testing and PQ.
You will provide technical oversight and onboarding of Contract Laboratory Operations (CLO) during the start-up phase
You will support the design and construction phase of the Microbiology laboratories and equipment selection/qualification.
You will establish qualified microbiology release testing including but not limited to Rapid Sterility, Genetic ID, Bioburden and Endotoxin.
You will establish the digital solution for the Microbiology Testing labs supported by the IT project team and global QC network.
You will own the EM and Utility report lifecycle, performing trend analysis and authoring site-level periodic reports to monitor facility performance.
You will be the QC Microbiology SME for the site and represent Holly Springs in Global Microbiology Forums to align with network best practices and Annex 1 requirements.
You will own Quality Management System records for Microbiology , including Deviations, Change Management Records (CMR), and CAPA.
You will deliver the ongoing training and professional development of the QC Microbiology team to ensure technical proficiency and "Right First Time" execution.
You will present Microbiology topics to regulatory (FDA/EMA) and internal inspectors.
You will continuously optimize lab performance through Lean coaching.
Who You Are
You hold a Bachelor’s degree in Microbiology, Biology or a related life sciences field with a minimum 8-11 years in a GMP laboratory environment (6-8 years with Masters, 3-6years with PhD).
You have in depth knowledge and experience of Utility and Environmental monitoring programs from sampling through to report authoring.
You have technical proficiency in Rapid Sterility platforms, Genetic ID, Bioburden, and Endotoxin.
You have extensive experience with LIMS and the use of automated/digital laboratory systems.
You must have proven experience managing Deviations, CMRs, and CAPAs within a regulated QMS (e.g., TrackWise, Veeva).
You have excellent attention to detail and strong analytical problem-solving skills.
You have experience presenting during regulatory, or internal inspections.
You must have strong communication and collaboration skills to work effectively with cross-functional and Global teams.
Work Environment / Physical Demands / Safety Considerations
Prolonged periods of standing at lab bench top. Frequent lifting (up to 25 lbs), bending, reaching, twisting, climbing stairs. Use of step ladders and push carts required.
Position may involve use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.
The expected salary range for this position is $90,000 to $167,000 . Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Relocation benefits are available for this position.
Benefits
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Genentech Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Genentech and has not been reviewed or approved by Genentech.
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Healthcare Strength — Health coverage is described as comprehensive across medical, dental, vision, mental health, and prescriptions, supported by HSAs/FSAs and broad wellness resources. On‑site fitness and health centers, mental‑health clinicians, and specialized programs like fully covered preventive cancer screenings and menopause support deepen the offering.
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Retirement Support — Retirement benefits feature a 401(k) with up to a 4% company match plus an additional annual 6% company contribution to eligible pay. Additional financial protections such as life and accident insurance complement salary, bonuses, and stock options.
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Leave & Time Off Breadth — Time away includes about 20 paid vacation days, paid holidays, personal days, and a year‑end shutdown. A paid six‑week sabbatical every six years notably expands long‑term time‑off flexibility.
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What We Do
Considered the founder of the industry, Genentech, now a member of the Roche Group, has been delivering on the promise of biotechnology for more than 40 years. Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. We're passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal. Making a difference in the lives of millions starts when you make a change in yours.
