Director, Quality Control

Raleigh, USA

The Director, Quality Control will be responsible for the organization and administration of all quality control functions of the Cellectis Raleigh facility, including ensuring that the company's products meet all relevant quality standards and specifications, leading and overseeing the company's Quality Control group, managing the company's quality control program, including internal and external analytical testing of raw materials and products, and establishing and maintaining appropriate Quality Control processes, policies and standard operating procedures.

Published on October 08, 2019

RESPONSIBILITIES:

  • Designs and implements labs at the manufacturing facility
  • Has responsibility for Method Development, Qualification and Validation
  • Responsible for routine testing and generation of Certificate of Analysis
  • Develops functional capabilities within the department to keep pace with advances in technology and company growth
  • Develops cooperative and strong working relationships with Manufacturing, Quality Assurance and MSAT to achieve company objectives
  • Develops and coordinates the Quality Control laboratory activities and capabilities to provide timely, accurate and cGMP compliant testing of raw materials, in-process materials, final product and contract manufactured materials
  • Ensures the proper investigation into the root cause of product failures, and assists in determining appropriate product disposition and/or process improvements
  • Ensures that any internal and external laboratories comply with GMP standards
  • Collaborates with MSAT and/or outside contract labs to ensure seamless method validation and transfer
  • Participates in business sub-teams as a Subject Matter Expert (SME) to provide input on timeliness and to address analytical/microbiological related issues
  • Such other responsibilities and duties as the company may from time to time assign.

QUALIFICATIONS:

  • The Director of QC must demonstrate ability to lead in a collaborative environment with a positive leadership style and a hands-on approach that emphasizes team work, collaboration, influencing, motivating, and consensus and team building. Good critical thinking, deductive reasoning, and decision-making skills are essential. The ideal candidate should have experience designing and implementing QC laboratories and establishing standard operating procedures.

REQUIREMENTS:

  • Bachelor's Degree in Chemistry, Biology or related sciences
  • Minimum 12 years of experience in pharmaceutical testing laboratory
  • 8+ years of direct supervisory experience
  • Comprehensive knowledge of biological and microbial analysis, manufacturing operations, GMP's and the theories and general principles behind them
  • Comprehensive knowledge of compliance with cGMP regulations
  • Understanding of laboratory equipment such as qPCR, Flow Cytometer, UV/Vis Spectrophotometer, Densitometer, Gel Imager, pH, Osmometer, etc.
  • Understanding and experience with relevant analytical and microbiological testing, methods development/validation, and environmental monitoring programs required to meet all regulatory requirements
  • Strong project management skills