Bristol-Myers Squibb - Seattle, WA
posted 4 months ago
At Bristol Myers Squibb, we are reimagining the future of cell therapy. The Director, Technical Operations Validation Lead is a pivotal role within our Cell Therapy Development and Operations (CTDO) organization, reporting directly to the Executive Director of Drug Product Cell Therapy Technical Operations. This position is responsible for providing technical oversight to drug product and vector sites, ensuring that equipment and process validation for commercial cell therapy products is conducted effectively across both internal and external manufacturing sites globally. In this role, you will serve as the Global Technical Subject Matter Expert (SME) for Drug Product and Vector Validation. You will be tasked with developing global technical standards for cell therapy validation and deploying these standards to site Manufacturing Science and Technology (MS&T) teams at both internal and external sites. Your responsibilities will include creating process validation standards, establishing a process qualification strategy, and implementing a continuous process verification (CPV) strategy that is consistent across products and sites. You will ensure that these standards are integrated into the quality system, which is crucial given the expansive scope of validation required for our growing cell therapy global network. As the Cell Therapy Lead, you will oversee the validation function, ensuring that all validation activities are conducted in compliance with industry regulations and best practices. You will be responsible for guiding teams in the development of master validation plans for processes, equipment, and facilities, and you will act as a global consultant for updates to existing site validation master plans. Your role will also involve providing timely technical support for validation-related inquiries, overseeing the review and approval of site-level deliverables, and authoring CMC summaries for regulatory submissions. This position requires a strong leader who can navigate the complexities of a global and matrixed environment, fostering collaboration across various functions and developing technical talent within the organization. You will be expected to exemplify strong leadership values and act as an ambassador for the company, particularly in the areas of validation and regulatory compliance. Your expertise will be critical in ensuring that our manufacturing processes are scientifically sound and compliant with global health authority expectations, ultimately contributing to our mission of transforming patients' lives through science.