Associate Director, Quality Control- Analytical Tech Services
We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.Job DescriptionEveryone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!We are seeking a highly motivated individual to join us as an Associate Director, to lead Quality Control Analytical Tech Services group, reporting to the Senior Director, Quality Control in Frederick, MD. In this role, you will lead a group and work closely with the Senior Director and other Associate Directors on supporting commercial operations in CAR-T technology.You will work on complex projects involving qPCR/ddPCR, Flow cytometry and cell-based bioassays and lead efforts in automation development for analytical assays. You will have cross-functional interaction with personnel from other groups such as Quality Assurance, Analytical Development, Manufacturing, Material Management (MM) and Corporate teams.Position Responsibilities (include but not limited to):Provide technical support, process trending and procedural updatesLead method validation and method transfers support continuous improvement, to support method/product/invalid trending, and to investigate laboratory/assay related findings.Lead and support method development, validations, and transfersSupport laboratory investigations, deviations, CAPAs, change control as neededAssist in investigation, identify root cause for critical deviations and determine CAPA for QC as neededEstablish data analytics to serve as metrics for monitoring trends in methods, products, and invalidsSupport incoming tech transfers from AD/PD as neededAuthor technical reports and protocols in support of cGMP activitiesSupervise, train, and mentor junior staffCreate and/or revise procedures, SOPs, and test methods as neededSupport equipment and software lifecyle processLIMS development and integrationProvide techni...