AS&T Scientist

5 days ago


Boston, Massachusetts, United States JMD Technologies Inc. Full time $200,000 - $250,000 per year

Role Overview:

Join a global biopharmaceutical organization supporting
late-stage and commercial Cell & Gene Therapy programs
. This position provides technical leadership for analytical method lifecycle management, regulatory documentation, and GMP quality investigations to ensure product consistency and compliance.

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
    .

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