Senior QC/Analytical Development Consultant for Cell and Gene Therapy

Three decades of experience in analytical sciences, quality systems development, and reg-CMC biologicals.

Will be able to provide expertise for analytical activities including stability testing, release testing, and in-process testing. Will also be able to implement new analytical methods including phase appropriate qualifications and validation of methods.

Relevant Disease Areas

  • Oncology
  • Immunology
  • Metabolic diseases

Product Technologies

  • Biologic
  • Small Molecule
  • Monoclonal antibodies
  • ADC
  • Nonviral, lentiviral, and AAV viral vectors
  • CAR-T

Recent Titles

  • VP, Analytical R&D and Quality Control
  • Executive Director, Analytical Sciences and Quality Control


  • Greater New Jersey Area
  • Open to remote and in-office

Relevant Companies

  • Roche
  • Progenics Pharmaceuticals

Relevant Skills

  • Manage QC staff members
  • IND/NDA filings
  • Implement new analytical methods
  • Oversight of sample outsourcing and contract laboratories
  • Provide leadership for internal and external audits and inspections
  • Develop and review SOPs, test methods, assay qualification, and validation protocols/reports

$250 / hr