Specialist, Investigations, Cell Therapy

Specialist, Investigations, Cell TherapyAt Bristol Myers Squibb, our employees often ask, "Who are you working for?"—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.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 Specialist, Investigations, Cell Therapy is responsible for leading and supporting deviation investigations within a cGMP-compliant cell therapy manufacturing environment. This role ensures timely, thorough, and scientifically sound investigations that drive effective corrective and preventive actions (CAPAs), contributing to continuous improvement and compliance with regulatory expectations.Shifts Available:Monday - Friday, 8am - 5pmResponsibilities:Conduct and manage the resolution of root cause investigations, including impact assessments, and CAPAs as a Lead InvestigatorDraft investigation reports and CAPAs, ensuring clarity, accuracy, and compliance with internal procedures.Ensure accurate and timely documentation of investigation activities in compliance with cGMP and internal procedures.Coordinate with Manufacturing, Quality Assurance, Quality Control, Engineering, and other departments to support investigation activities.Track and support the implementation of CAPAs, including scheduling, documentation, and verification of effectiveness.Participate in continuous improvement initiatives by identifying recurring issues and contributing ideas for process enhancements.Stay current with investigation procedures, regulatory expectations, and quality systems through ongoing training and development.The Specialist reports to the Senior Manager, Investigations, Cell Therapy within the site Manufacturing Science & Technology department.Knowledge & Skills:Familiarity with investigation processes, CAPA systems, and quality documentation.Strong attention to detail, organizational skills, and ability to manage multiple priorities.Effective communication and interpersonal skills to work collaboratively across teams.Proficiency in Microsoft Office and experience with electronic quality systems (e.g., Infinity, TrackWise, Veeva) is a plus.Understanding of Quality Risk Management and Operational Excellence principles.Requirements:Knowledge of science generally attained through studies resulting in a bachelor's degree in science, engineering, biochemistry or related discipline plus 1-3 years' experience in biopharmaceutical operations, or its equivalent is required.Working Conditions:Position may require working in Clean-Room manufacturing environment approximately 15% of the time. The remainder of work is performed in an office environment.We hire for skills and capabilities, not just credentials – if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.