At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder’s world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Science, Respect, Collaboration and Courage, and it reflects who we are and the environment we are creating.
The individual in this role provides strategic leadership for all CMC activities, the 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 individual supports regulatory submissions of CMC sections resulting in world-wide marketing approvals for drug products.
KEY ROLE AND RESPONSIBILITIES:
- Establish and drive the organization’s 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 solid tumor cancers
- Provide strategic direction, tactical oversight and technical expertise for CMC functions, including Process Development, Analytical Development, Manufacturing (including contract manufacturing for plasmids, vector and cells), 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
- Collaborate with Quality Assurance in the timely review of manufacturing documents, process deviations, and CMO audits.
- Select, build, develop and maintain a highly skilled team
- 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 pharmaceutical 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 of 10 years in management-level positions with increasing responsibilities including significant executive level experience
- Experience within the life sciences sector, and relevant biopharmaceutical industry experience
- 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
- 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 C-Level and cross-functional peers in a variety of departments (Research, Clinical Development, Information Sciences/IT, Business Development, Legal, Finance, People Team, etc.)
- Demonstrated 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
- Proven 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
At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees.
Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company’s facilities and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.”
We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.