Senior Director/Executive Director, Manufacturing Sciences and Technology, Holly Springs

Roche • South San Francisco, CA

19h • Hybrid

About The Position

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: As a member of the Holly Springs Site Leadership Team (SLT), you will be accountable for the Product Lifecycle (Technical Risk Assessment, Product Control Strategies, Continued Process Verification, Process Robustness Assessment) to include the Process Engineering program and Process Validation program, New Product Introductions (NPIs), Technical Transfers and new technology introduction of this facility through plant start-up in 2028 and ongoing commercial manufacturing. In the start-up and development phase of the project you will work closely with Global Product Development teams as the molecules go through clinical development and operational readiness, taking site ownership for the entire lifecycle of the medicines. You will lead, inspire and influence a highly proficient and engaged team of engineers, scientists and manufacturing experts in technical fit assessments, product introductions, process design and development, and qualification and validation activities through licensure. The team is also responsible for the internal or external product transfers to commercial operations. This includes strategic long-range planning and operational planning. Together with the SLT, you will be accountable for setting a high performance site culture. You will create an environment embracing Innovation to continuously improve the product for efficient production throughout its lifecycle You will collaborate with peers, removing silos to balance requirements and remove barriers within and across functions You will ensure new medicines are launched as planned and that technical support is provided to the commercial operation to maintain strong product supply You will be fully accountable for the management of the discretionary functional budget You will ensure “right-first-time” and a short order lead-time by implementing a customer-oriented lean end-to-end mindset You will collaborate with network and external partners to ensure the site receives the highest level of technical and process expertise and partnership in all aspects of manufacturing

Requirements

• BS/BA degree in life sciences, physical sciences, or engineering. Post graduate-level training (e.g., Ph.D., MSc or MBA) is preferred
• Visionary, an effective Architect, Coach and Catalyst (VACC), with a proven record developing people and their technical capabilities
• Technical expert in many areas of biotech drug product launch and manufacturing, with fifteen plus (15+) years biotech/pharmaceutical experience with five plus (5+) years in the biotech drug product and finished goods manufacturing environment
• Strong business acumen with a solid knowledge of key performance indicators (safety, quality, delivery, engagement and cost) at a drug product/finished goods manufacturing site
• Fundamental understanding of quality systems and the application of current Good Manufacturing Practices (cGMPs)
• Lean mindset and end-to-end thinking with a focus on continuous improvement
• Excellent communication skills at both global and local levels, including presenting highly technical concepts to regulatory authorities
• Demonstrated ability to perform at a high level in an environment that exhibits significant ambiguity and absence of precedent
• Able to create clarity and focus and remove barriers for execution
• Able to challenge principles and assumptions, listen actively and provide a safe environment for expressing different and alternative ideas

Responsibilities

• Accountable for the Product Lifecycle (Technical Risk Assessment, Product Control Strategies, Continued Process Verification, Process Robustness Assessment) to include the Process Engineering program and Process Validation program, New Product Introductions (NPIs), Technical Transfers and new technology introduction of this facility through plant start-up in 2028 and ongoing commercial manufacturing.
• Work closely with Global Product Development teams as the molecules go through clinical development and operational readiness, taking site ownership for the entire lifecycle of the medicines.
• Lead, inspire and influence a highly proficient and engaged team of engineers, scientists and manufacturing experts in technical fit assessments, product introductions, process design and development, and qualification and validation activities through licensure.
• Responsible for the internal or external product transfers to commercial operations. This includes strategic long-range planning and operational planning.
• Accountable for setting a high performance site culture.
• Create an environment embracing Innovation to continuously improve the product for efficient production throughout its lifecycle
• Collaborate with peers, removing silos to balance requirements and remove barriers within and across functions
• Ensure new medicines are launched as planned and that technical support is provided to the commercial operation to maintain strong product supply
• Fully accountable for the management of the discretionary functional budget
• Ensure “right-first-time” and a short order lead-time by implementing a customer-oriented lean end-to-end mindset
• Collaborate with network and external partners to ensure the site receives the highest level of technical and process expertise and partnership in all aspects of manufacturing

Benefits

• Relocation benefits are provided
• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director