AssociateDirector,QCOperations

Bachelor's degree in biology, chemistry, life sciences or a related field, and 10+ years of analytical experience in biologics or CGT in an industry setting (or M. S. and 8+ years of experience), At least 6 years of experience in a GMP setting, Expertise with analytical method transfer and phase appropriate validation/qualification, Familiarity with relevant FDAA and ICH regulatory guidelines relevant to gene and cell therapy, analytical development, and method validation, Experience enabling and overseeing contract test laboratories for cell and/or gene therapy products and managing quality events and investigations, Experience with late phase to commercial programs (cell therapy, gene therapy or biologics), Experience with QC analytical methods optimization and troubleshooting for cell and gene therapy products including potency assay, immunoassays/flow cytometry, PCR, etc., A clear sense of ownership and accountability to meet commitment and high standards promoting the same with CDMO partners, Ability to communicate effectively with scientific/technical colleagues in a dynamic, cross-functional environment, Excellent organizational skills, with a proven ability to manage multiple matrixed projects and tasks to completion in a fast-paced environment, anticipating risks and obstacles and adjusting to effective contingency plans, Flexibility - ability to adapt to changes and priorities to fulfill our mission, including after-hours or weekend support for batch release when required to deliver product to a patient, Systems thinking - You approach problem solving and process design with consideration of the overall system as well as its individual parts, considering interrelationships and patterns, A track record of context-based sound judgement, including when to elevate risks and issues to leadership, Collaborative and accountable – recognizes success requires interdisciplinary thinking and shares feedback and ideas, productively challenges own and others’ assumptions to facilitate better outcomes, Self-motivated, with a proven ability to work with general direction to meet objectives and timelines, managing multiple responsibilities in parallel, Curious and humble – seeks and welcomes input/expertise of others, continuous learner, Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments, Operates with urgency, adept at building buy-in and driving alignment within and across teams, senior leadership, and external partners, Seeks the data, information, and support needed (internally and externally) to make efficient and informed decisions and meet objectives, Continuous learner – actively follows innovations in area of expertise, fosters innovative thinking, and adopts novel approaches that are fit for reflective and self aware