Senior Cell Therapy Specialist I, Manufacturing and MSAT

ArcellxRedwood City, CA
53dOnsite

About The Position

As a Sr. Cell Therapy Specialist (Manufacturing and MSAT), your mission is to deliver to patients every time! Our potentially life-saving treatments would not exist without the work of our cell therapy team. Your work will have a tremendous impact on our ability to deliver our transformative cell therapy to the patients who need it most.

Requirements

  • Bachelor’s degree in in relevant scientific field and 8+ years of industry experience preferably in cell therapy manufacturing
  • Excellent aseptic techniques and experience with cell processing equipment
  • Ability to operate within a clean room environment for long durations
  • Prior experience mentoring or training team members
  • Strong problem-solving and decision-making capability
  • Strong understanding of cGMP quality principles
  • Excellent organizational and prioritization skills
  • Exceptional collaboration, communication, and interpersonal skills
  • Flexibility to work weekends, holidays, or shift schedules as required

Responsibilities

  • Independently execute complex cell therapy manufacturing activities with high proficiency:
  • Operation of manufacturing equipment for batch production
  • Media preparation, reagent handling, buffer preparation
  • Aseptic processing in controlled cleanroom environments
  • Serve as point-of-contact for troubleshooting manufacturing issues in real time
  • Lead and train junior specialists / associates in aseptic techniques and the manufacturing process
  • Provide technical support for T-cell manufacturing process changes, process validation, discrepancy / deviation, and investigation evaluation
  • Document all activities in accordance with Good Documentation Practices (GDPs)
  • Author and review documents including MBRs, protocols, deviation reports, change controls, and SOPs.
  • Participate in risk assessments, gap/facility fit analysis, deviation investigations, change controls, CAPAs, and root-cause analysis.
  • Ensure compliance with internal and regulatory standards
  • Partner closely with MSAT, QA, QC, Supply Chain, and Facilities teams

Benefits

  • 100% coverage for medical, dental and vision for team members and dependents, unlimited vacation, a 3-day weekend every month, fully-paid parental leave for up to 6 months, tuition reimbursement, 401k employer contribution and more.
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service