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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 Pharma Technical Operations (PT) Global MSAT & Engineering (PTT) group takes bold steps to modernize technical operations so Roche can deliver medicines for patients more quickly, efficiently and reliably. In partnership with PT colleagues, we shape and accelerate technology innovation and product lifecycle management for tomorrow, while standardizing and driving operational excellence in PT today.
The PTT - global Manufacturing Science and Technology (gMSAT) department focuses on technical support for commercial products in our internal and external drug substance and drug product network, implementation of new technologies, network standardization and distribution technologies.
Equipment Design Finalization & Operational Readiness
As a key technical steward, you will focus on driving the site toward operational readiness:
Process Equipment Design Finalization: Collaborate closely with engineering firms and equipment vendor to finalize the detailed design, technical specifications, and ensure critical process configurations/functiobalities are correctly reflected on all core process equipment FAT & SAT protocols.
End-to-End Aseptic Integration: Ensure the finalized equipment designs deliver flawless processing across all sterile unit operations: Compounding, Buffer & Bulk Filtration, Sterile Filtration, Aseptic Filling, and Visual Inspection.
Automation & PAT Deployment: Partner with Automation, IT, and Global teams to drive the on-site implementation, testing, and deployment of advanced robotics, automated material handling, real-time data analytics, and Process Analytical Technology (PAT) tools.
CQV Partnering & Execution: Provide expert technical input into Commissioning, Qualification, and Validation (CQV) strategies based on User Requirement Specifications (URS). Collaborate directly with external CQV service providers to review deliverables and actively participate in the on-the-floor execution of CQV protocols, troubleshooting equipment performance gaps to ensure a successful handover.
Technology Transfer Setup: Define and establish the technical baseline for incoming pipeline products / molecules, ensuring the finalized facility and equipment capabilities are physically prepared to receive tech transfers seamlessly.
SOP & Operations Partnership: Partner directly with the Operations team to co-author, review, and finalize unit operation Standard Operating Procedures (SOPs), ensuring they are delivered on time and technically accurate ahead of water runs and engineering batches.
Workforce Readiness & Training: Serve as the technical lead for operator training initiatives; translate complex automated, PAT, and aseptic technical concepts into digestible training modules to support floor-operator qualification.
Excellent Vendor, Engineering Firm & Contractor Management
Excellent Project Management & Timeline Adherence
Technical Skills & Competencies
Domain Expertise: Recognized expert in aseptic processing and sterile filling drug product manufacturing, with deep technical knowledge spanning from compounding, buffer/bulk preparation, and filtration through to visual inspection.
Equipment Design & Vendor Relations: Proven capability in finalizing technical design specifications with process equipment vendors and collaborating with external engineering firms to see concepts built.
Hands-on CQV Execution: Experience partnering with external CQV service providers, with a proven willingness and capability to get on the manufacturing floor to execute testing, participate in FAT/SAT, and troubleshoot equipment during commissioning and qualification process.
Automation, Robotics & PAT Savvy: Strong technical familiarity with advanced automation, automated visual inspection (AVI) systems, isolated filling lines, digital manufacturing tools, and the implementation/validation of Process Analytical Technology (PAT) applications.
Sterilization & Decontamination: Deep technical understanding of core sterilization science, including cycle development/qualification and Vaporized Hydrogen Peroxide (VHP) decontamination technologies for isolators.
Risk & Change Tools: Mastery of Quality Risk Management (QRM) tools, specifically FMEA, alongside a robust understanding of formal change control/implementation procedures in a GMP environment.
Project Delivery: Excellent project management skills with a proven track record of being methodical, highly organized, and driving strict adherence to project timelines. Familiarity with Agile frameworks is a plus.
Collaboration & Training Ability: Natural capability to partner across functional lines (especially with Operations and Quality teams) to communicate technical steps clearly for SOP creation and training execution.
Minimum Requirements:
Education: Advanced degree in a technical, engineering or scientific field.
Industry Experience: 8+ years of professional experience in large molecule sterile production technology(prior greenfield start-up or major facility execution/expansion experience is highly preferred).
Leadership Experience: 5+ years of matrix team leadership, cross-functional team leadership, or people management experience.
You are willing to travel up to 20%
Relocation benefits are not available for this posting.
The expected salary range for this position based on the primary location of Holly Springs, NC, is $114,400 to $212,400. 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.
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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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