Senior/Executive Director, Manufacturing - Compounding, Filling, Inspection (CVRM)

Genentech • Holly Springs, NC

197d • $164,000 - $304,000

About The Position

Pharma Technical Manufacturing (PTM) is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche's ground-breaking therapies to more than 120 million patients around the world. We make our medicines at 9 sites around the world and coordinates all aspects of production of Roche medicines in all disease areas and dosage forms. To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, 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). As the Senior/Executive Director, Manufacturing you are initially accountable for the design, qualification and ramp-up of the green field high volume facility's Compounding, Filling, and Inspection operations, including strategic workforce planning, hiring the respective personnel, setting up the organization, all relevant processes and documents/documentation (e.g. SOPs and batch documentation). You are responsible for ensuring timely ramp-up including the project management activities, IT systems and definition of the specifications and processes in compliance with GMP/Quality requirements. You will identify timeline risks or bottlenecks for the project timeline or future site operations and take appropriate actions. You will work closely with all the key areas to achieve ambitious goals in terms of on time, on cost and on scope delivery. Following go-live of the facility, you will transition into a routine operations/site leadership position and will extend into daily operation responsibilities. As the owner of all Compounding, Filling, and Inspection systems and assets, you are accountable for the safe, accurate & efficient preparation, maintenance, calibration, functionality and reliability of all respective manufacturing areas, equipment, systems, and processes. You will build and effectively execute the agenda for Compounding, Filling, and Inspection operations to ensure reliable delivery for commercial products and new tech transfers. You will build and maintain strong partnerships with other Manufacturing units, Quality, MSAT, Facility, Engineering & SHE, ITOT, Material Management, People & Culture, Finance, Global Operations and other functional areas to assure site and department goals are achieved. Initially, you will perform a mix of remote and onsite work (first at the General Planner's office, later at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. (International) travel of up to 30% of the time is expected during the project phase.

Requirements

• Bachelor's degree in pharmaceutical, life sciences, physical sciences, or engineering.
• 20+ years of significant bio/pharmaceutical experience for Senior Director level and 25+ years for Executive Director level.
• Significant professional experience in steriles manufacturing, including cross-functional team management and leadership.
• Extensive professional experience with operations management in high-volume low cost device combination products or similar.
• Strong project management skills, ideally experience with ramping up new manufacturing sites or operations.
• Vast knowledge of safety, quality systems and quality assurance concepts and systems, including the application of current Good Manufacturing Practices (cGMPs).
• Strong creative leadership skills, ability to build forward looking perspectives and remove barriers.
• Ability to inspire, adopt, coach and apply lean and agile ways of working.
• A consistent track record to perform against tight timelines in a highly complex and ambiguous environment.
• Expertise and experience in organizational change management and expertise in delivering a long-term vision.

Nice To Haves

• Advanced degree (Masters or PhD).
• Post Graduate-level course work, including management training (e.g., an MBA).
• International experience at multiple sites/locations.

Responsibilities

• Lead the compounding/filling/inspection part (incl. utilities) of the User Team during the facility start-up project, prepare and transform into routine operations.
• Drive timely project execution through strategic thinking, technical and entrepreneurial understanding combined with social intelligence.
• Foster a strong mindset for safety, quality and compliance.
• Take purposeful and impactful decisions.
• Demonstrate disciplinary and professional leadership promotion and deployment of personnel including the assurance of adequate initial and ongoing training.
• Carry out employee appraisal reviews incl. performance assessment and salary responsibility.
• Define goals with employees and evaluate the achievement of goals. Support the development of employees.

Benefits

• Discretionary annual bonus based on individual and Company performance.
• Relocation benefits are provided.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees