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The Director, Cell Therapy Analytical Development, Characterization and Quality Control - Biologics Product Development in the Division of Therapeutic Discovery is a key talent reporting to the Vice President. After decades of unrealized potential, cell therapies are at the precipice of a revolution in impacting oncology treatment. MDACC is well-positioned to play a pivotal role by bringing together world-leading innovative academic scientists with experts in industrial development. An appropriate analytical approach to assessing product quality is essential to product development. The Director will combine an understanding of the biology of the cellular therapies with analytical technology capabilities in the context of developing a pharmaceutical. Developing a robust approach to CQAs, matching appropriate analytical methods to attributes and then executing that release panel in the GMP QC lab is the core of this role. The opportunity is to pair a candidate's experience in industrial assay development and execution with academic labs who are world-leaders in understanding the science. In this way we will not merely meet Health authority expectations, but inform and influence them. In order to achieve this, the Director will define an organizational structure, recruit talent, develop a team and lead their execution. They will be a key member of the Biologics Product Development senior staff, which defines the strategy and oversees selecting and developing Biologics at MDACC. Therapeutics Discovery and Development Division MD Anderson Cancer Center (MDACC), the largest research-based cancer center in the nation, is taking a unique approach in the battle against cancer. It is well-known that MDACC is home to an esteemed academic faculty that cover all aspects of cancer research, publish prolifically in leading journals and present extensively at all major conferences. In addition MDACC boasts a vast oncology clinic that runs more clinical trials than any other institution and has created unparalleled capabilities is cell therapy trials. In between the basic science and the translation, MDACC has created a powerful engine driving the future of new targeted, immune- and cell-based therapies: the Therapeutics Discovery and Development (TDD) Division. TDD eliminates the bottlenecks that hamper traditional drug discovery, with a multidisciplinary team of dedicated researchers, doctors, drug developers and scientific experts working together to develop small-molecule drugs, biologics and cellular therapies. Our unique structure and collaborative approach allows the team to work with agility, bringing novel medicines from concept to clinic quickly and efficiently all under the same roof. Biologics Product Development Biologics, be it monoclonal antibodies (mAbs) or cell therapies are complex therapeutics that are revolutionizing the treatment of cancer and yet are difficult to robustly develop and manufacture. To unlock the potential of these modalities MDACC is investing in Biologics Development capabilities within TDD accelerate the results we have already achieved, with multiple programs currently in clinical development. The goal will be to develop industrial biologics with a commercial horizon within the innovative environment of an academic cancer center. The group will be a composite of industry veterans who are interested in applying their experience to develop innovative therapeutics and see them impact patients, as well as academics looking to turn science into products. We work in a fast-paced, milestone-driven environment with a focus on team science and interdisciplinary research. Our unique approach has created a biotech-like engine within the walls of the nation's leading cancer center to bring life-saving medicines to our patients more quickly and effectively. Qualifications PhD in scientific field with 10+ years of experience in biologics development, with emphasis on cell therapies and viral vectors Experience in overseeing clinical phase GMP release and stability testing Leadership capabilities to define, populate, manage and develop a team Demonstrated ability to collaborate effectively in a multi-disciplinary team Demonstrated strong communication skills, interpersonal skills and a superior drive for results Excellent written, oral, interpersonal and presentation skills and the ability to effectively interface with senior management and staff Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills Ability to operate as an effective tactical, as well as strategic thinker Demonstrated ability to craft Regulatory filings to clearly define CQAs, control strategy and characterization knowledgeown the science. 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Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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