Director, Technical Operations Validation Lead

$182,000 - $228,000/Yr

Bristol-Myers Squibb - Seattle, WA

Full-time - Senior

Seattle, WA

Chemical Manufacturing

About the position

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.

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 existing site validation master plans.
• Develop and guide process validation, qualification and process monitoring strategies and framework.
• Guide the teams to storyboard and present cell therapy global validation framework, standards, and approaches during major health authority inspections.
• Ensure timely technical support for validation related questions for routine manufacturing, lifecycle process changes, quality audits and health authority inspections.
• Provide oversight via review and approval of network site level deliverables, including Validation Master Plans, process validation protocols, impact assessments and risk assessments.
• Author and review CMC summaries of validation for worldwide regulatory submissions for initialization and life-cycle changes.
• Design qualification strategies to support novel applications of fill, filtration, sterilization and single-use disposable technologies.
• Facilitate cell therapy harmonization for existing manufacturing sites and adoption of industry best practices.
• Work with process development and analytical development to ensure early pipeline assets have a robust process for future validation when in pivotal trials.

Requirements

• B.S/MS.S/Ph. D in Chemical Engineering or Life Science
• 12+ years of relevant experience in the biopharmaceutical company with most of that experience demonstrating progression of leadership responsibilities and scope.
• Previous experience should be a combination of technical operation functions such as manufacturing, quality, MS&T or Technical Development.
• At least 10 years of direct experience in GMP environment is necessary.
• Ability to define the right processes for the team's maturity level, balancing agility and discipline.
• Career track record and industry reputation should be competitive at the highest level among industry peers.
• Demonstrated skill to lead large, complex technical organizations with global scope and build people, processes, and technology in a growing organization.
• Strong leadership track record especially in the areas of leading in a global and matrix environment, working cross functionally and developing strong technical talent.
• Excellent communication skills and ability to strategically influence the direction of the company in the scope areas mentioned above.
• Experience leading regulatory inspections regarding validation and extensive knowledge of regulations, current industry practices, and experience with interpretation and application of guidelines and regulations.
• Experience with Quality Management System.
• 2-3 years of experience in cell therapy process development and or manufacturing preferred.
• Combination of experience in process development, MSAT and quality, experience with manufacturing automation systems/platform, preferred.

Nice-to-haves

• Experience in cell therapy process development and manufacturing.
• Experience with manufacturing automation systems/platform.

Benefits

• Medical, pharmacy, dental and vision care
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP)
• Financial well-being resources and a 401(K)
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support
• Work-life programs including paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility
• Parental, caregiver, bereavement, and military leave
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources
• Tuition reimbursement and a recognition program