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Director/Senior/Executive Director, Process Development

Company: CRISPR Therapeutics
Location: Somerville
Posted on: January 12, 2021

Job Description:

Company OverviewAt CRISPR Therapeutics, we are focused on developing transformative gene-based medicines for serious human diseases.We are rapidly translating our specific, efficient and versatile CRISPR/Cas9 gene-editing platform into therapies to treat hemoglobinopathies, cancer, diabetes and other diseasesOur multi-disciplinary team of world-class researchers and drug developers works every day to translate our CRISPR/Cas9 technology into breakthrough human therapeutics. Our lead program targeting the blood diseases ---thalassemia and sickle cell disease has entered clinical testing, and our immuno-oncology programs, focused on CRISPR/Cas9-edited allogeneic CAR-T cell therapies, have the potential to deliver a new generation of cancer therapies to patients.Position SummaryThe primary focus of the Head of Hemoglobinopathies Process Developmentwill be to drive execution of CRISPR---s process development objectives in support of our Hemoglobinopathies program. The Head of Hemoglobinopathies Process Development will also work closely with R&D colleagues to support lifecycle management of the heme products, and also work in close collaboration with our process development colleagues at our partner Vertex.The Head of Hemoglobinopathies Process Development will be required to develop effective organizational development strategies and have a keen sense and demonstrated ability to work at the bench or in the manufacturing plant. The Heme development team, a collaborative team staffed by engineers and scientists at CRISPR Tx and Vertex, is growing very fast. A well-structured, flexible approach is required to support organization changes and growth as clinical development direction and timelines shift. Combining strong leadership skills, strong technical skills and an ability to lead by example is a must.We are looking for a demonstrated leader with the breadth of professional experience and the drive to work with internal partners and Vertex to define and implement our shared vision to assure robust supply of CRISPR cell therapy products for treatment of Sickle Cell Anemia and Beta Thalassemia. The ideal candidate will be strategic, highly knowledgeable in cell and gene therapy, have a solid technical operations background, and understand the challenges and impact of managing a collaborative effort, from early-stage through late stage development and into GMP manufacturing. We need someone who is able to work effectively in a rapidly growing company against tight and changing deadlines. ResponsibilitiesProvide leadership for execution of Heme Process Development activities at CRISPR. Develop and grow the Heme Process Development team to support registration filings in multiple jurisdictions in the near future.Provide Hemoglobinopathies process development team of scientists and engineers to optimize Drug Product process technology for Sickle-Cell and Beta Thalassemia cGMP manufacturingWork in partnership with CRISPR Tx partner, Vertex, to execute Heme process development program across companies.Oversee long-range development of the Heme development team. Hire, mentor and retain staff for process development, tech transfer processes to cGMP manufacturing and support process validation.Design and execute process development studies to develop a detailed understanding of operating and performance parameters.Define Critical Quality Attributes and optimize Critical Process Parameters in support of IND and BLA filings, during process development.Write and review technical documentation. Draft documentation for regulatory filings.Provide cross-functional leadership at CRISPR, working with Analytical Development, R&D, Quality, Manufacturing and Supply chain to ensure commercial success of Heme Development program.QualificationsPhD degree in Life Sciences discipline appropriate to gene editing and cell and gene therapy programs at CRISPR TX (immunology, cell biology, biochemical engineering, etc.). 10 years of experience working in biopharmaceutical process development, cGMP manufacturing, and technical operations. Fluent in cGMP requirements.Practical demonstration of hands on process development including use of statistical design of experiments.Experience leading process development functional groups.Demonstrated ability to lead matrix teams.Demonstrated experience in management of external partners.Ability to influence executive management.Ability to expresses self clearly and concisely to key stakeholders; document issues and/or concerns concisely and comprehensively; and articulate well-reasoned recommendations for leadership endorsement; adjust style, language and/or terminology appropriate for the audience across the breadth of and through the depth of the organization.Strong leadership and an innate ability to collaborate and build relationships is critical.Experience of driving and motivate teams to meet aggressive timelines and deliverables.Flexible and comfortable working with ambiguity as the program priorities follow the science and clinical outcomesPassion for innovation and problem-solving.SummaryLocation: Cambridge, MA, United StatesType: Full TimeExperience: ExecutiveDepartment: Process Development

Keywords: CRISPR Therapeutics, Somerville , Director/Senior/Executive Director, Process Development, Executive , Somerville, Massachusetts

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