Associate Director/Director, Quality Control

Position Summary

The Director of Quality Control will oversee the Quality testing efforts within the company maintaining compliance with FDA CFR parts 210 and 211, ICH Q series, and EU GMPs.  Processes will initially be focused on viral vector and nucleic acid based cancer vaccine products.   The Director of Quality Control supports the Gritstone drug product manufacturing process with the following responsibilities:

  • Develop, implement, and manage appropriate QC personnel and systems to support drug product manufacturing and release
  • Set up and manage a Quality Control Laboratory including equipment identification, method validation (ICH Q2 (R1)) and staffing
  • Develop and manage a QC equipment program including calibrations, qualifications, and equipment change control
  • Use of analytical methods for in process, final product and stability testing
  • Establish and manage a raw material testing program in collaboration with Development and Manufacturing groups
  • Establish and manage an Environmental Monitoring and Personnel Monitoring Program at Gritstone manufacturing facilities
  • Partner with the Analytical Development group to ensure successful transfer, qualification, and validation of analytical methods to QC
  • Establish and manage stability programs for intermediates, drug substances, and drug products
  • Prepare and technically review QC documentation such as Certificates of Analysis (COAs), specifications, analytical method procedures, qualification/validation protocols/reports
  • Provide oversight of outsourced QC activities at Contract Test Labs including review of supplier documents and COAs
  • Investigate Out of Specification(OOS) results and perform impact assessments and corrective actions in collaboration with Manufacturing and Quality Assurance

Minimum Education/Experience

  • BA/BS degree in technical discipline (e.g. Chemistry/Microbiology) required; advanced degree preferred
  • 10 years of experience in QC or analytical development in the biotechnology of pharmaceutical
  • 5 years of QC laboratory management
  • In-depth experience and working knowledge in biologics analytical test methodologies (vaccine therapy and plasmid analytical therapies preferred) and regulatory/pharmacopeia requirements for biologic testing
  • Experience in molecular biology and gene therapy/viral vector methods including qPCR, ELISA, virus titer assays, particle size assays, cell based potency assays
  • Experience with analytical test method qualification and validation
  • Experience with incoming raw material testing and release systems
  • Experience with clean room environmental monitoring and personnel monitoring programs

Other Qualifications

  • Strong organizational skills and attention to detail
  • Able to work effectively in a fast-paced, small start-up company environment
  • Self-motivated, self-disciplined and able to function independently as well as part of a team
  • Strategic agility, strong critical and logical thinking with ability to analyze problems
  • Strong ability to prioritize, multi-task, and work in an evolving environment.
  • Excellent presentation and written/verbal communication skills
  • Excellent computer proficiency (MS Word, Excel, PowerPoint)