At 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.
Position Summary
This is a hybrid role with a minimum of 50% onsite at the Cell Therapy Facility in Devens, MA, with flexible hours and occasional as-needed, off-hours support for urgent needs, typically handled remotely.
Bristol Myers Squibb is seeking a Senior Manager for QC Analytical at the Cell Therapy Facility (CTF) in Devens, MA. This role supports the QC analytical operations team, develops and reports KPIs for performance, and oversee QC projects. Maintain high team performance and drive continuous improvement initiatives using operational excellence tools. Collaborate with managers across the QC network to harmonize best practices.
Duties/Responsibilities
Lead and oversee the QC Analytical lab, ensuring effective, timely, and efficient testing and data review for in-process, release, and stability testing of clinical and commercial cell therapy drug product.
Lead by example to foster a culture of teamwork, safety, quality, and operational excellence, and embed BMS values within operational activities.
Develop, track, trend, and report KPIs for QC Analytical performance (e.g., turnaround time, right-first-time, backlog). Drive continuous improvement initiatives using operational excellence tools.
Own one or more QC programs or functional areas. Lead the team to develop, deploy, and maintain the program.
Hire, mentor, and develop team members to support business operations and career development. Provide developmental feedback and coaching, and create a collaborative environment that enhances team performance and integration across site departments.
Approve test methods, procedures, and documents to ensure operational alignment and compliance with corporate policies and procedures.
Approve change controls, investigations, deviations, and CAPAs; drive meaningful root cause analysis and effective corrective and preventive actions. Support local and network quality events and QC Analytical impact assessments.
Serve as QC Analytical representative and escalation point for cross-functional partners. Foster communication across shifts and between QC Technical Support, QC Operations, and other CTF teams.
Collaborate with managers across the QC network to harmonize best practices.
Communicate effectively with senior management regarding performance, roadblocks, risks, and resource needs.
Responsible for cGMP and data integrity compliance in all aspects of laboratory operations. Represent the department in regulatory inspections and internal/external audits.
Provide on-call and shift coverage support as needed to support QC analytica operations.
May directly manage QC analytical analysts.
Perform other tasks as assigned.
Reporting Relationship
Associate Director, QC Analytical
Qualifications
Specific Knowledge, Skills, Abilities:
Demonstrated leadership and management skills, including establishing strategic direction and goals, and guiding execution while fostering a team-based environment.
Experience with various bioanalytical techniques (cell-based assays, ELISA, qPCR, flow cytometry) and associated equipment.
Experience with laboratory LIMS, ELN, data analysis systems (e.g., DeltaV), and ERP systems (e.g., SAP) preferred.
Ability to work in a highly regulated environment and follow regulatory requirements and GMPs.
Advanced ability to work collaboratively in a high-paced team environment, meet deadlines, and prioritize work from multiple teams and projects.
Strong written and…