Senior Vice President, Technical Operations

Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response. We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell’s product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to advance next-generation CAR T-cell therapies, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency.

POSITION SUMMARY:

This role provides strategic leadership for all CMC activities, technical knowledge transfer, process development, analytical characterization, quality control, manufacturing and supply chain activities for the organization. The role leads early stage, clinical and commercial manufacturing, testing, and characterization of cell-based immunotherapies. In addition, the role supports regulatory submissions of CMC sections resulting in world-wide marketing approvals for drug products.

KEY ROLE AND RESPONSIBILITIES:

• Establish and drive the organizations mission and strategic vision as it relates to its technical operations

• Establish and execute overall CMC development, registrational and commercial strategy for Lyell’s pipeline of cell-based immunotherapies for hematologic and solid tumor cancers.

• Provide strategic direction, tactical oversight and technical expertise for CMC functions, including Quality, Process Development, Analytical Development, Manufacturing, Supply Chain Management, and ultimately scale-up for commercialization.

• Serve as subject matter expert for all regulatory CMC submissions, including authoring (directly or via direct reports) of technical content.

• Interface with FDA and other global regulatory agencies.

• Select, build, develop and maintain a highly skilled team in alignment with Lyell’s Talent Philosophy and people practices.

• Conduct analyses and provide recommendations as to when to insource vs. outsource strategic manufacturing.

• Support team in diligence of additional assets and in licensing discussions with potential partners.

PREFERRED EDUCATION & EXPERIENCE

• BA/BSc in biology, engineering or a related scientific field with a minimum of 20 years’ experience; or

• MBA with a minimum of 15 years’ experience

• Minimum 10 years’ experience operating at an executive leadership level

• Experience within the life sciences sector is required, and relevant biopharmaceutical industry experience is strongly preferred including cell therapy

• Demonstrated experience in leading and driving manufacturing, process scale-up and commercial operations

• Significant experience and reputation as a leader and manager, both within a manufacturing function and with functional peers.

KNOWLEDGE, SKILLS AND ABILITIES:

• A seasoned leader who demonstrates sound business judgment, people leadership, while instilling best practices supported by analysis, data and metrics.

• A high level of intellectual curiosity and emotional intelligence and a track record as a strong leader

• Proven ability to work with and communicate with his/her peers across all functions (Research, Clinical Development, Information Sciences/IT, Business Development, Legal, Finance, People Team, etc.).

• Knowledge of best practices and exposure to established, well run, complex companies, ideally including recent leadership within a company that has developed new life sciences products.

• A high degree of knowledge of the value-drivers in biopharma product development, and ability to integrate this with other disciplines to develop creative and impactful strategic people plans

• Experience as a business and thought partner to senior leadership teams, with the ability to build effective peer and senior relationships, influence key business decisions and track performance against key objectives

• Demonstrated strong influencing skills, with an ability to work effectively with external stakeholders, as well as with internal colleagues

• Experienced in the capabilities and management of outside consultants and contract organizations.

• Skilled at preparing, negotiating and managing formal agreements and contracts with third parties, including supply agreements.

• Effective organizational traits with demonstrated project management, leadership, stakeholder management and influencing skills.

• Demonstrated capability in CMC regulatory affairs to support registrational strategy design, document preparation and FDA product approval.

• Extensive knowledge of cGMPs, quality systems and industry standards.