Senior QC/Analytical Development Consultant for Cell and Gene Therapy

Three decades of (bio)analytical development and CMC from preclinical programs to commercial launch. Has ample managerial and implementational experience with Biologics including gene therapy, vaccines, monoclonal antibodies, and recombinant proteins.

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

  • Vaccines
  • Inflammatory diseases
  • CNS
  • Oncology
  • Metabolic diseases

Product Technologies

  • Biologic
  • Small Molecule
  • Monoclonal antibodies

Recent Titles

  • Senior Director, Analytical Development
  • Group Leader, Process Analytics, Bioprocess Development, and Manufacturing


  • Greater Philadelphia Area
  • Open to remote and in-office

Relevant Companies

  • Shire
  • Johnson & Johnson

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

$350 / hr