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Holly Springs, North Carolina, United States
Onsite
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:
In this exciting role, you will be an integral member of the User Team and will provide scientific and technical leadership for the new large-volume manufacturing facility in Holly Springs. This role specifically focuses on the design, qualification, start-up, and registration of the facility’s Dispensing, Compounding, and Powder Handling area.
Serving as a critical technical anchor for the site, this role necessitates advanced expertise in process safety and high-containment engineering to manage the hazards posed by a low-OEL material with highly sensitive flammability and electrostatic characteristics. Following the go-live of the facility, you will transition into a routine position at the site, extending into daily operational responsibilities.
As the Lead for this area, you will be accountable for:
Technical Leadership: You will provide expertise in project management, technical design, testing, qualification, and validation for all activities related to the dispensing and compounding area.
Safety & Hazard Mitigation: You will define and implement the engineering control strategy required to safely manage flammability and hybrid material risks and electrostatic hazards of the API.
Cross-Functional Collaboration: You will partner with Engineering, MSAT, Quality, Supply Chain, Technical Development, Regulatory, and CMO organizations to drive technical decisions that balance project, product, quality, and operations views.
Process Design & Scalability: You will design geometrically similar compounding trains (150L and 750L) to ensure scalable mixing dynamics across a wide range of batch sizes (50L to 700L), including buffer preparation and pH-controlled compounding.
Project Execution: You will champion assigned parts of the project, justifying goals to management, and working with suppliers/contractors to transition design plans into a functioning, approved manufacturing process.
Regulatory Submission: You will design and execute studies and comparability protocols to support operations and contribute directly to cGMP documentation and regulatory filings.
Who you are:
Education & Experience: You hold a Bachelor’s, Master’s, or Ph.D. degree in Bio/Chemical Engineering or a related discipline, with 12+ years of experience in the pharmaceutical/biotech industry with 3+ years in powder handling.
Technical Authority: You are an expert in aseptic compounding, fluid dynamics, and automated powder handling. You possess the ability to translate material properties (MIE, PSD, Resistivity) into robust, high-volume manufacturing requirements.
Strategic Influencer: You understand the "bigger picture" of large-volume, low-cost manufacturing and can effectively partner with and influence stakeholders across the organization without formal authority.
Mentor & Coach: You are committed to providing knowledge and training on complex process technologies, developing training materials for new staff, and coaching colleagues with less experience.
Champion of Safety: You foster a positive safety culture where no one gets hurt, ensuring environmental health, safety, and security are integrated into all business and manufacturing processes.
Preferred:
You have experience with "Smart Factory" concepts and digital transformation to drive business and project efficiency.
You have direct experience defending process design and safety concepts during Health Authority inspections.
You have advanced knowledge of global ATEX/NEC standards for hybrid mixture environments.
Work Environment/Safety Considerations:
Ability to work in an international/global environment. Domestic and international travel required. Travel up to 20% after full relocation.
Will work in a clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves, and steel toe boots.
Potential to work near hazardous materials, chemicals, and equipment as per company safety procedures and guidelines.
This role will require full onsite work at the project office before transition to the site offices once complete.
The expected salary range for this position in Holly Springs, NC is $114,400 - $212,400. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
Relocation benefits are provided.
Link to 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.