Principal Scientist, Analytical Development - Gene Therapy
Eli Lilly and Company
2 months ago
On-site
Boston, MA
Operations
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).
Basic Qualifications:
- 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.
Preferred Qualifications / Skills:
- 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 (HEK293 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).
Work Authorization:
- Must be authorized to work in the U.S. full-time; no visa sponsorship.
Compensation/Benefits (eligible employees):
- 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.
- 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).
Basic Qualifications:
- 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.
Preferred Qualifications / Skills:
- 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 (HEK293 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).
Work Authorization:
- Must be authorized to work in the U.S. full-time; no visa sponsorship.
Compensation/Benefits (eligible employees):
- 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.