Chief Technical Officer, CMC Manufacturing

Lyell Immunopharma, Inc. Seattle , WA 98101

Posted 7 months ago

At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founders 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 Respect, Science, Courage and Intensity, and it reflects who we are and the environment we are creating.

With offices in Seattle and South San Francisco, Lyell Immunopharma is currently seeking an exceptional leader to join our team.The Chief Technical Operations Officer will be a key leader of our management team and will coordinate the strategic direction and operational responsibilities of the CMC team with key responsibilities related to manufacturing processes of CAR-T research, clinical and commercial products for worldwide distribution. The CTO will work very closely with other functions of the company, including Regulatory, Quality, Clinical Operations, Development, Supply Chain, etc.

The ideal candidate will have extensive experience leading CMC activities and deep technical knowledge of technology transfer, process development, analytical characterization, quality control, manufacturing and supply chain activities of monoclonal antibodies and antibody conjugates. The candidate will have demonstrated knowledge of GLP and GMP and experience with early stage, clinical and commercial manufacturing, testing, and characterization of cell-based immunotherapies. The ideal candidate will have a proven track record of supporting regulatory submissions of CMC sections resulting in world-wide marketing approvals for drug products.

Lyell has innovative science that will require novel approaches to manufacturing. Experience developing new processes for biologics or cell therapy manufacturing, innovative approaches to working with health authorities and superb strategy skills are necessary to be successful in this competitive and new space.

This is an exceptional opportunity to build, lead and develop a successful CMC function in a dynamic start-up company driven by a leadership team of proven drug developers.

Essential Functions:

  • Participate in management and board discussions
  • Establish and execute overall CMC development, registrational and commercial strategy for Lyells 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 QA in the timely review of manufacturing documents, process deviations, and CMO audits.
  • Select, build and develop 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.

Requirements

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.

  • 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.
  • Proven ability to build and lead multi-disciplinary teams.
  • 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.


Preferred Education/Experience:

  • Advanced degree in biology, chemistry, engineering or related scientific field.
  • Minimum of 15 years of pharmaceutical development /manufacturing experience with at least 4 years in Biologics.
  • Thorough knowledge of manufacturing techniques, process scale-up and commercial operations.

Knowledge, Skills and Abilities:

  • Small company / pre-commercial stage company experience desirable
  • Strong collaboration and teamwork skills
  • Effective leader of others and ability to mentor/develop team members
  • High self-awareness and commitment to iterative learning and development
  • Effective communicator, verbal and written, strong interpersonal skills

Benefits

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.

Weve learned from experience that some of the best people dont always match our requirements perfectly - if youre interested and think you could fit, please dont hesitate to apply.

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.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited or unable to access or use this online application process and need an alternative method for applying, please contact us via our career website.

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Chief Technical Officer, CMC Manufacturing

Lyell Immunopharma, Inc.