Lyellimmunopharma

Senior Director, Manufacturing

Bothell, Washington, United States. Posted 15 days ago

The role

The Senior Director of Manufacturing leads the cell therapy manufacturing organization through the transition from clinical-stage to commercial operations. This person owns GMP manufacturing execution across the product lifecycle and builds a scalable commercial manufacturing organization.

What you will do

  • Lead manufacturing readiness for BLA filing, PLI, and commercial launch.
  • Develop and execute the manufacturing strategy, including capacity planning and site expansion.
  • Partner with Supply Chain, Quality, and Commercial to ensure reliable vein-to-vein performance.
  • Direct day-to-day clinical and commercial manufacturing.
  • Drive right-first-time execution, batch record quality, and on-time batch disposition.
  • Own deviations, CAPAs, and change controls arising from manufacturing.
  • Maintain a continuous state of inspection readiness and serve as a senior representative during audits.
  • Partner with Process Development and MSAT to ensure process transfer, scale-up, and lifecycle management.
  • Lead manufacturing success rate, cost of goods, and cycle-time improvement.
  • Build, scale and mentor a high-performing organization.

Required qualifications

  • BA/BSc in Molecular Biology, Immunology, Biotechnology or related discipline with a minimum of 20 years' experience
  • MBA or MSc in Molecular Biology, Immunology, Biotechnology or related discipline with a minimum of 15 years' experience
  • Excellent oral and written communication skills
  • Ability to work independently and collaboratively among cross-functional teams
  • Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities
  • Excellent analytical skills and scientific/technical expertise

Nice to have

  • Minimum of 15+ years of experience in biotechnology bioprocessing, GMP manufacturing and/or CMC development
  • Experience in GMP manufacturing setting, technology transfer and implementation of new technologies in a regulated environment
  • Experience with the assessment of new technologies in a fast-paced, learning organization
  • Prior experience in either design, qualification, start-up of manufacturing facilities
  • Cell therapy experience

Benefits

  • Annual bonus
  • Lyell’s Equity Incentive Plan

About the company

Lyell is a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. The company is fully integrated, capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients.

Senior Director, Manufacturing at Lyellimmunopharma | JobZoey