Cmc Analytical Scientist

GenScript USA Inc

Pennington, United States
Base: $80k - $110k; bonus/equity: not specified; b...
On-site
Lentiviral vector release testing experience
Qpcr and ddpcr assay expertise
Western blot and flow cytometry skills
The role involves supporting the set-up, development, and maintenance of a GMP QC-Analytics Lab within a global CDMO environment

Job Summary

  • The role involves supporting the set-up, development, and maintenance of a GMP QC-Analytics Lab within a global CDMO environment.
  • Candidates will generate and characterize engineered cell lines while developing molecular and cellular assays to assess vector performance.
  • The position requires ensuring compliance with BSL-2 biosafety standards, cGMP, and applicable regulatory requirements while driving continuous improvement.

Matching Summary

The role involves supporting the set-up, development, and maintenance of a GMP QC-Analytics Lab within a global CDMO environment.

Salary

Base: $80k - $110k; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Lentiviral vector release testing experience
  • qPCR and ddPCR assay expertise
  • Western blot and flow cytometry skills
  • GMP manufacturing process knowledge
  • Cell-based assay development

Nice-to-have

  • NGS-based methods for vector characterization
  • EU Annex 1 laboratory audit experience
  • FDA and ICH regulatory guidance familiarity
  • BSL-2 biosafety standards compliance

Key Requirements

  • Ph.D. with 2+ years or M.S. with 3+ years in relevant field
  • Hands-on experience in lentiviral vector release testing
  • Working knowledge of Good Documentation Practices and ALCOA+

Work Rights

Not specified

Tailored Resume

Cover Letter