Location: Raleigh,NC, USA
Job DescriptionWho We Are:Cellectis is a clinical-stage biopharmaceutical company focused on developing a new generation of cancer immunotherapies to target and eradicate cancer cells. Cellectis utilizes gene-edited T-cells (UCART) to create cost-effective off-the-shelf products from healthy donors that can be immediately made available to patients across all geographies.By capitalizing on our 21 years of expertise in gene editing and built on our flagship trademark technology and pioneering electroporation system, we seek to use the power of the immune system to address unmet therapeutic needs. Using life-science-focused, pioneering genome engineering technologies, our goal is to create innovative products in multiple fields and with various target markets.Cellectis is on an incredible journey and we are looking for passionate individuals to join us on this important mission and in our commitment to a cure.Who We Are Looking For: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 Quality Control group, managing the 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. This position is also part of the Global Cellectis Quality Leadership team actively contributing to the overall global Quality strategy and initiatives.Position Responsibilities Has responsibility for Method transfer, optimization, Qualification and Validation within BioAssay, Microbiological, Raw Material laboratories as well as Outside Testing Laboratories. Responsible for routine testing of products for release, stability, and characterization Responsible for the Environmental Monitoring program 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, Analytical Development, 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, starting materials, in-process materials, and final product Ensures the proper investigation into the root cause of OOS/OOT results and assists in determining appropriate product disposition and/or method 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 assignEducation And Experience Bachelor's Degree in Chemistry, Biology or related sciences Minimum 12 years of experience in pharmaceutical testing laboratory 8+ years of direct supervisory experience Understanding and experience with relevant analytical and microbiological testing, methods development/validation, and environmental monitoring programs required to meet all regulatory requirements The ideal candidate should have experience designing and implementing QC laboratories and establishing standard operating proceduresTechnical Skills / Core Competencies 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. Strong project management skills Demonstrated 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.