Senior Manager, QC Analytical-1

Bristol Myers Squibb • Devens, MA

1d • Hybrid

About The Position

Bristol Myers Squibb is seeking a Senior Manager for QC Analytical at its Cell Therapy Facility in Devens, Massachusetts. This hybrid role requires a minimum of 50% onsite work and provides flexible hours, with occasional as-needed off-hours support for urgent needs, typically handled remotely. The position supports QC analytical operations, develops and reports performance KPIs, oversees QC projects, maintains high team performance, and drives continuous improvement. The role also collaborates with managers across the QC network to harmonize best practices.

The Senior Manager leads the QC Analytical laboratory and ensures effective, timely, and efficient testing and data review for in-process, release, and stability testing of clinical and commercial cell therapy drug products. The role develops team capability, promotes teamwork, safety, quality, and operational excellence, and owns one or more QC programs or functional areas. It is responsible for laboratory cGMP and data integrity compliance, quality documentation and event approvals, and representing the department during regulatory inspections and audits. The position reports to the Associate Director, QC Analytical and may directly manage QC analytical analysts.

Requirements

• Bachelor's degree or equivalent required, preferably in science; an equivalent combination of education and experience may substitute.
• 10 or more years of relevant laboratory work experience, preferably in a regulated environment.
• 4 or more years of management and people-leader experience.
• Demonstrated leadership and management skills, including establishing strategic direction and goals and guiding execution while fostering a team-based environment.
• Experience with bioanalytical techniques such as cell-based assays, ELISA, qPCR, and flow cytometry, and associated equipment.
• Ability to work in a highly regulated environment and follow regulatory requirements and GMPs.
• Ability to collaborate in a fast-paced team environment, meet deadlines, and prioritize work across multiple teams and projects.
• Strong written, verbal, and interpersonal communication skills, including the ability to communicate effectively and concisely with peers, department management, and cross-functional partners.
• Ability to apply Lean, Six Sigma, and Risk Management concepts and tools.
• Excellent organizational and critical-thinking skills, problem-solving, and decision-making abilities.
• Proficiency with Excel, Visio, PowerPoint, and other common software applications.
• Demonstrated success working in a high-performing, results-driven environment.
• Ability to lift up to 20 lbs (9 kg) at floor and waist height and up to 10 lbs (4.5 kg) overhead; push or maneuver carts to transport materials.
• Ability to perform frequent pipetting and related laboratory tasks within a biological safety cabinet, including extended periods of seated work.
• Ability to independently don, doff, and wear required PPE, such as a lab coat or frock, gloves, and safety glasses or face shield, for prolonged periods.
• Ability to safely handle and use chemical disinfectants, flammable materials, and hazardous chemicals; work may involve dry ice, liquid nitrogen, and cryogenically cooled materials.
• Ability to use step stools while reaching and handling materials and to work in a Biosafety Level 2 (BSL-2) environment.
• Perform work safely in accordance with EHSS procedures, including identifying and controlling risks, using PPE properly, safely handling chemicals and biological agents, following waste and emergency procedures, and participating in training and safety programs.

Nice To Haves

• Advanced degree preferred.
• Experience with laboratory LIMS, ELN, data analysis systems such as DeltaV, and ERP systems such as SAP.

Responsibilities

• Lead and oversee the QC Analytical laboratory, ensuring effective, timely, and efficient testing and data review for in-process, release, and stability testing of clinical and commercial cell therapy drug products.
• Promote teamwork, safety, quality, operational excellence, and BMS values in operational activities.
• Develop, track, trend, and report QC Analytical performance KPIs, such as turnaround time, right-first-time performance, and backlog.
• Drive continuous improvement initiatives using operational excellence tools.
• Own one or more QC programs or functional areas and lead their development, deployment, and maintenance.
• Hire, mentor, and develop team members; provide developmental feedback and coaching and foster a collaborative environment.
• 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.
• Represent QC Analytical and serve as an escalation point for cross-functional partners.
• Foster communication across shifts and among QC Technical Support, QC Operations, and other CTF teams.
• Collaborate with managers across the QC network to harmonize best practices.
• Communicate performance, roadblocks, risks, and resource needs to senior management.
• Ensure cGMP and data integrity compliance in all aspects of laboratory operations.
• Represent the department in regulatory inspections and internal and external audits.
• Provide on-call and shift coverage support as needed for QC Analytical operations.
• May directly manage QC analytical analysts.
• Perform other tasks as assigned.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to plan terms and eligibility.
• Flexible Time Off (FTO) without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
• Paid vacation for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico; new hires receive 160 hours annually, subject to manager approval.
• 11 paid company holidays each year; eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico also receive 3 optional holidays.
• Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• May be eligible for additional discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior