Cell Therapy Experts – Full Time

4 weeks ago


ireland Lachman Consultant Services, Inc. Full time

Cell Therapy Experts: Lachman Consultants, the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic, and dietary supplement industries, is seeking accomplished Cell Therapy Regulatory and Compliance experts to add to its team of full-time & per diem consultant professionals. The professional must have a strong background and demonstrable hands-on experience and skills.

Key Responsibilities:
  • Deep knowledge of cell therapy; CAR T cell therapy and adoptive cell therapy
  • Demonstrated understanding of ATMs
  • Understanding of analytical and bioanalytical testing methods including multi-flow cytometry, dose determination assay, cell-based analysis, gene expression profiling
  • CAR-T strategies, direct experience with CAR-T programs
  • Scientific expertise and leadership to CAR-T teams
  • Quality Operations / Quality Systems – implementation of QMS and processes for cell therapy products
  • Regulatory requirements pertaining to cell therapy and biologics
  • Knowledge of FDA, EU, and International regulations, and industry best practices regarding documentation systems, design control, change control, product specifications, and applicable GxPs
  • Filing requirements for cell therapy products
  • Novel cellular therapies based on CAR and/or Engineered T Cell Receptor (eTCR) technologies
  • Cell biology and high-content data analysis subject matter expertise
Educational / Experience Requirements:
  • M.S. (Ph.D. Preferred) in immunology or molecular and cell biology, bioengineering, or related field
  • 10+ years of experience in the biopharma industry
Apply to:

https://lachmanconsultants.ie/career-opportunities/

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