Pharma Technical Manufacturing (PTM) is responsible for managing all aspects of Drug Product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver ground-breaking therapies to more than 120 million patients around the world. We make our medicines at 9 sites around the world and coordinate all aspects of production in all disease areas and dosage forms.
To ensure readiness for a step-change in the standard of care in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Springs, North Carolina. The new site will focus on large-volume, low-cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products).
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 11+ years (Senior Principal) or 15+ years (Distinguished) of experience in the pharmaceutical/biotech industry.
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.
The expected salary range for this position in Holly Springs, NC, for a senior principal engineer (11-14 years exp) is $114,400 - $212,400. For a distinguished engineer (15+ years exp), the range is $138,300 - $256,800. Actual pay is determined by experience, qualifications, and other job-related factors.
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.
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