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Volnay Therapeutics

Product Design Lead

Volnay Therapeutics, Cambridge, Massachusetts, us, 02140


Position Overview:

We are looking for a highly skilled and experienced scientist to join our team as the Product Design Lead. This role demands a deep understanding of immunology and cell therapy, as well as expertise in process biology, CAR engineering, preclinical assays, gene editing, and viral vector design. The successful candidate will lead efforts to optimize cell therapy platforms, with a focus on enhancing both potency and durability. Utilizing their expertise in immune cell biology, including gene engineering, immune cell activation, survival, proliferation, and function, they will oversee the progression of discovery projects into clinical development. This position also involves close collaboration with internal teams and external partners, including CMOs, to drive innovation and success across our therapeutic platforms.Accountabilities:This Associate Director-level role is lab-based and will oversee the design, execution, and strategic direction of cell therapy research initiatives to foster innovation. Initially, the role will primarily be laboratory-based, designing and performing experiments on a day-to-day basis to support the portfolio of projects at Volnay. The role has the potential to eventually expand in scope to manage a team of scientists.Lead the optimization and execution of cell therapy platforms by enhancing both potency and durability through advanced engineering techniques. Design and execute strategies for cell process, CAR engineering, gene editing, and viral vector design to improve therapeutic efficacy.Ensure successful integration of process biology into the design and development of scalable therapeutic products. Drive cross-functional research initiatives by coordinating efforts between scientific teams to push forward discovery and development milestones.Design, conduct, and analyze in vivo, in vitro, and ex vivo experiments to elucidate the mechanisms of action of therapies, contributing to scientific discussions that inform critical project decisions.Oversee the development and validation of preclinical assays to assess immune cell functionality, activation, survival, and proliferation. Direct discovery projects from early-stage research to clinical development, ensuring seamless transition through each phase.Collaborate with internal teams and external partners, including CMOs, to accelerate the development of innovative cell therapy platforms. Apply deep expertise in immune cell biology to guide the engineering of novel cell therapy products.Stay informed on emerging trends and advancements in immunology, gene editing, and cell therapy to incorporate the latest innovations into product design. Monitor project progress and make strategic adjustments to meet clinical development goals and timelines effectively.Author, coordinate, and review technical documents, protocols, and reports, providing subject matter expertise for regulatory submissions.Qualifications:Education:Ph.D. in Immunology, Molecular Biology, Biology, or a related field.Experience:A minimum of 7 years of relevant experience in the pharmaceutical industry, biotech or academia, specifically focused on cell therapy and related research.Extensive hands-on experience in immunology and cell therapy platforms, with a focus on process biology, CAR engineering, gene editing, and viral vector development.Proven track record of leading discovery projects from research to clinical development within biotech, pharma, or academia.Technical Skills:Expertise in various cell-based therapy assays and techniques, including CAR-T, CAR-NK, CAR- T, TCR-T, iPSC-T, and regulatory T cell therapies, with proficiency in cell culture, activation, transduction and immune cell expansion.Familiarity with process biology principles and their integration into cell therapy product development, including scalability and manufacturability is requiredExperience in preclinical assay development, immune cell functionality testing, and validation in the context of cell therapy. Proficiency in designing and executing in vivo, in vitro, and ex vivo experiments to assess immune cell functionality, potency, and persistence is essential.The individual should have significant skills in in vitro and in vivo immune cell characterization and function assessment, such as multi-color flow immunophenotyping, multiplex cytokine measurement, cytotoxicity assays, and other molecular-based assays.Detail-oriented with exceptional organizational skills and proficiency in problem-solving and decision-making processes.Core Competencies:Proven leadership capabilities, with experience overseeing scientific teams and driving project outcomes effectively.Exceptional analytical and innovative problem-solving skills with strategic project management capabilities.Strong written and verbal communication skills with an ability to articulate complex scientific concepts to diverse audiences.This role requires a candidate with a strong ability to thrive in a fast-paced biotech or startup environment, demonstrating flexibility and a willingness to take on diverse responsibilities as needed.Preferred Qualifications:A record of published research in reputable scientific journals demonstrating proficiency in related fields.Past experience collaborating with cross-functional teams and managing external partnerships.