Cell & Gene Therapy Scientist
2 days ago
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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