Location: Raleigh,NC, USA
Who 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 ResponsibilitiesHas 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 characterizationResponsible for the Environmental Monitoring programDevelops functional capabilities within the department to keep pace with advances in technology and company growthDevelops cooperative and strong working relationships with Manufacturing, Quality Assurance, Analytical Development, and MSAT to achieve company objectivesDevelops 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 productEnsures the proper investigation into the root cause of OOS/OOT results and assists in determining appropriate product disposition and/or method improvementsEnsures that any internal and external laboratories comply with GMP standardsCollaborates with MSAT and/or outside contract labs to ensure seamless method validation and transferParticipates in business sub-teams as a Subject Matter Expert (SME) to provide input on timeliness and to address analytical/microbiological related issuesSuch other responsibilities and duties as the company may from time to time assignEducation And ExperienceBachelor's Degree in Chemistry, Biology or related sciencesMinimum 12 years of experience in pharmaceutical testing laboratory8+ years of direct supervisory experienceUnderstanding and experience with relevant analytical and microbiological testing, methods development/validation, and environmental monitoring programs required to meet all regulatory requirementsThe ideal candidate should have experience designing and implementing QC laboratories and establishing standard operating proceduresTechnical Skills / Core CompetenciesComprehensive knowledge of biological and microbial analysis, manufacturing operations, GMP's and the theories and general principles behind themComprehensive knowledge of compliance with cGMP regulationsUnderstanding of laboratory equipment such as qPCR, Flow Cytometer, UV/Vis Spectrophotometer, Densitometer, Gel Imager, pH, Osmometer, etc.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 buildingGood critical thinking, deductive reasoning, and decision-making skills are essential.#J-18808-Ljbffr