Cell & Gene Therapy Scientist

2 days ago


Boston, Massachusetts, United States Intellyk Full time $90,000 - $120,000 per year

Key Responsibilities:

  • Lead or support analytical method validation, transfer, and lifecycle activities.
  • Author and review technical protocols, reports, SOPs, and regulatory filings.
  • Serve as Subject Matter Expert (SME) for analytical troubleshooting and quality events.
  • Support deviations, CAPAs, and change controls.
  • Perform data trending, statistical analysis, and laboratory testing where applicable.
  • Collaborate with internal teams and external partners, including CTOs and CDMOs.

Qualifications:

  • Bachelor's or higher in Biology, Biochemistry, or Analytical Chemistry.
  • 8+ years in the pharma/biopharma industry, preferably GMP environment.
  • Strong knowledge of ICH, cGMP, and regulatory guidelines.
  • Hands-on experience with HPLC/UPLC, flow cytometry, mass spectrometry (MS).
  • Experience with Reference Standard and analytical method lifecycle management.
  • Excellent technical writing and communication skills.

Preferred:

  • Experience in cell/gene therapy or CRISPR-based programs.
  • Proficiency in JMP or other statistical tools.
  • Familiarity with critical reagent management and analytical QC support.

Job Type: Contract

Pay: $ $60.00 per hour

Work Location: Hybrid remote in Boston, MA 02210



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