Director, Technical Operations Validation Lead

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Title: Director, Technical Operations Validation Lead

Location: Seattle, WA, Devens, MA or Summit, NJ

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The Director, Technical Operations Validation Lead reports to the Executive Director, Drug Product Cell Therapy Technical Operations within the Cell Therapy Development and Operations (CTDO) organization. This Technical Leadership  role will provide Technical oversight to drug product and vector sites covering equipment and process validation for commercial cell therapy products manufactured globally via internal and external manufacturing sites.

This role will be serve as the Global Technical SME for Drug Product and Vector Validation. The lead will develop global technical standards for cell therapy validation and deploy the standards to site MS&T at internal and external sites. The process responsibilities include developing process validation standards, process qualification strategy and framework for cell therapy processes, continuous process verification (CPV) strategy and implementation in a consistent manner across products and sites and ensuring that these standards are reflected in the quality system. Given the broad scope of validation for the expanding cell therapy global network, this role will work across the broader CTO organization to ensure alignment of key focus areas and priorities, develop strategic vision for the groups, hire and develop the leaders for the sub-function and recruit the technical talent.

The Cell Therapy Lead will cover process, equipment and supporting elements of manufacturing validation for all cell therapy products in the portfolio, internal and external manufacturing processes/facilities for the plasmid, viral vector and drug product. The person will own the accountability for the Validation function by providing oversight of all the validation activities, including providing SME assessment for proposed process life-cycle changes. The lead will serve as the Global Point of Contact for sites and will work with the sights to provide oversight and drive activities utilizing site Personnel.

This person will also support validation activities needed during design and build of new manufacturing plants to make sure the engineering approaches consider our harmonized validation framework that is compliant with the global health authority expectations and scientifically sound.

Key Responsibilities:

• Lead, develop and implement scientifically sound and fit for purpose validation standards and procedures based on current regulations, industry standards and industry best practices for cell therapy.
• Create, maintain, deploy global cell therapy validation technical standards via quality system.
• Promote innovative and efficient approaches to validation incorporating risk-based elements and considerations unique to cell therapy production.
• Lead, develop and implement the master validation plans for process, equipment, and facilities, in collaboration with the validation and technical SME network.
• Serve as global consultant for update and revision of exiting site validation master plans.
• Develop and guide process validation, qualification and process monitoring strategies and framework.
• Guide the teams to storyboard and prese