Lead Cell Therapy Specialist

AstraZenecaLos Angeles, CA
Onsite

About The Position

In this role, you will lead and coordinate daily manufacturing execution, ensuring personnel, materials, equipment, documentation, and cleanroom areas are ready before operations begin. You will drive right first time execution by providing real-time technical mentorship, coaching, and troubleshooting support during production runs. This position also plays a significant role in maintaining schedule adherence, supporting shift handovers, advancing risks in real time, and partnering cross-functionally with Manufacturing, Quality, MSAT, Process Development, Supply Chain, and Facilities and Engineering. You’ll also support training, deviation investigations, CAPAs, process documentation updates, and continuous improvement efforts that help strengthen operational readiness and future commercial success.

Requirements

  • High School Diploma with at least 5 years of relevant cell therapy, pharmaceutical, biotech, or GMP manufacturing experience, OR a Bachelor’s degree with at least 3 years of relevant experience
  • Experience working in a cGMP manufacturing environment
  • Experience with aseptic technique, cleanroom behavior, cell culture operations, and single-use technologies
  • Proven ability to lead work on the manufacturing floor and guide team members during execution
  • Strong understanding of SOPs, batch records, production records, and quality systems
  • Ability to recognize deviations from accepted practice and advance appropriately
  • Strong written and verbal communication skills
  • Strong attention to detail, accountability, and ability to thrive in a regulated, fast-paced, and changing manufacturing environment
  • Skilled at working effectively across Manufacturing, Quality, MSAT, Process Development, Supply Chain, and Facilities and Engineering
  • Ability to work in a cleanroom environment requiring gowning
  • Ability to stand for extended periods and perform repetitive movements, reaching, bending, and careful handling of materials or equipment
  • Required to carry and lift up to 30 pounds daily and push or pull up to 50 pounds daily
  • May work around strong magnets, niche manufacturing equipment, human blood products, biological materials, vapor phase liquid nitrogen, or cryogenic materials
  • Ability to work assigned shifts, weekends, holidays, and overtime as the need arises by the manufacturing schedule
  • Must follow all safety, contamination control, gowning, documentation, and cGMP requirements

Nice To Haves

  • Priority experience in cell therapy manufacturing
  • Experience supporting technology transfer and GMP clinical or commercial manufacturing operations
  • Experience training or mentor team members in GMP processes
  • Experience supporting deviation investigations, CAPAs, change controls, SOP revisions, or batch record improvements
  • Experience with paper and electronic batch records, manufacturing execution systems, inventory systems, or quality management systems
  • Proven ability to make timely decisions, manage competing priorities, and know when to intensify
  • Able to work with minimal direction while setting daily priorities for self and others

Responsibilities

  • Lead and coordinate daily manufacturing execution
  • Ensure personnel, materials, equipment, documentation, and cleanroom areas are ready before operations begin
  • Provide real-time technical mentorship, coaching, and troubleshooting support during production runs
  • Maintain schedule adherence
  • Support shift handovers
  • Advance risks in real time
  • Partner cross-functionally with Manufacturing, Quality, MSAT, Process Development, Supply Chain, and Facilities and Engineering
  • Support training, deviation investigations, CAPAs, process documentation updates, and continuous improvement efforts

Benefits

  • Eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles
  • Qualified retirement programs
  • Paid time off (i.e., vacation, holiday, and leaves)
  • Health, dental, and vision coverage
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