Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
This position will be a member of the Global Manufacturing Sciences and Technologies group within the Cell Therapy Development & Operations organization at Bristol-Myers Squibb (BMS). This position has responsibilities that include leading/supporting scale-out, technology transfers, process validation, optimization and continuous improvement activities for new and existing cell therapy products. The position is also responsible for ownership of the process control strategy and providing specialized expertise in support of manufacturing related critical investigations and change control activities.
Responsibilities will include, but are not limited to, the following:
Own and lead process control strategy to enable seamless and robust Tech Transfer to commercial manufacturing sites, and support commercial drug product manufacturing operations including such as isolation, cell culture, harvest and formulation activities for cellular therapies
Lead and support technical evaluation of Change Notifications and assist with implementation at multiple sites
Troubleshoot issues with drug product processing technologies and equipment
Design of protocols, execution, reporting and approval of qualification and validation reports that support life cycle maintenance
Develop process and product monitoring plans, master data and documentation management, compliance to BMS quality systems, and other readiness operational support activities.
Provide assistance to sites globally to resolve significant quality events and manage complex change controls
Develop and implement process improvement strategies
Coordinate internal and external resources to produce empirical data
Review and co-author sections of the CMC filings
Foster strong inter-team relationships to achieve common project goals
B.S., M.S. or Ph.D in Engineering or life science with 8-15 years of relevant technical experience in technical development, manufacturing science or other disciplines in technical operations.
Strong understanding of bioprocess unit operations, especially cell culture.
Excellent written and verbal communication skills. Ability to convey complex technical issues to diverse audiences including internal teams, external partners, and health authorities.
Demonstrated experience developing and/or transferring drug products within a pharmaceutical environment.
Proficient in project management and team leadership skills, with a thorough understanding of critical unit operations involved in drug product manufacturing.
Experience in technical supervision, coaching and mentoring or leading small matrixed teams of people or scientific projects.
Evidence of strong communication skills and of building good relationships with cross functional team members and customers.
Established scientific professional with track record of technical and cultural leadership and globally-recognized accomplishments that include advancing projects. Influences site and global strategy. Visible contributions to external scientific community, including regulatory settings.
Experience in product/process CMC life cycle management including pre-approval, launch and post-approval stages.
Strong analytical, problem-solving, and critical thinking skills.
Sound experience of data handling and applied statistics.
Experience with Quality Management System (e.g. Deviations, CAPAs, Change Management)
In managing technical interactions with CMOs, manufacturing of cell therapies, or product life cycle management is highly desirable
Previous experience in managing direct technical staff is highly desirable
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.