Principal Scientist, Analytical Development - Gene Therapy

Job Responsibilities:

• Follow relevant business, compliance, regulatory, quality, environmental, and safety policies; make sound technical decisions and communicate them to others.
• Manage project deliverables across multiple projects/phases; may serve as project lead.
• Execute and assess analytical methods; set up, operate, and troubleshoot instruments (AUC, bioassay, ELISA, vector genome titer).
• Perform routine analytical and in vitro bioassays to characterize product quality, strength, and potency.
• Document results using good documentation practices (e.g., ELN, test data worksheets).

• BS with 10+ years OR MS with 8+ years in analytical development/molecular biology/biochemistry/chemistry/biotech/chemical engineering or related field.
• Experience leading analytical method development, qualification, validation, transfer, and lifecycle management in regulated environments (e.g., GMP) for gene therapy/advanced modalities.
• Track record supporting early/late-stage development, comparability, regulatory submissions, and/or commercial readiness for viral vector/gene therapy.

• Potency and functional assay development/execution (cell-based; MOA-relevant).
• Hands‑on ELISA, cell‑based assays, AUC; qPCR/ddPCR, vector genome quantification, capsid/impurity analysis (highly preferred).
• AAV knowledge; production models (HEK
  293 or Bac/SF9); critical quality attributes; phase-appropriate analytical strategy; leadership in technical strategy/risk.
• Experience with CRO/CDMO/testing lab collaborations; data integrity/compliance; mammalian cell culture/aseptic techniques (preferred).

Must be authorized to work in the U.S. full‑time; no visa sponsorship.

Anticipated base pay: $71,250–$187,000; possible company bonus; 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, leave benefits, and well‑being benefits.