Senior Manager, QC Analytical-1

Bristol Myers Squibb • Devens, MA

2d • $124,590 - $150,977 • 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 position requires at least 50% onsite work and supports QC analytical operations, performance reporting, and QC projects. The role leads continuous improvement and operational excellence initiatives and collaborates with managers across the QC network to harmonize best practices.

The Senior Manager oversees laboratory testing and data review for in-process, release, and stability testing of clinical and commercial cell therapy drug products. The role promotes a culture of teamwork, safety, quality, and operational excellence; manages QC programs; develops team members; and supports compliant, effective laboratory operations. The position serves as an escalation point and representative for QC Analytical with cross-functional partners, senior management, and during inspections and audits. On-call, shift coverage, and occasional urgent off-hours support may be required; urgent support is typically handled remotely.

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 setting strategic direction and goals and guiding execution in 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 in a high-performing, results-driven environment.
• Ability to lift up to 20 lbs (9 kg) at floor and waist height; lift up to 10 lbs (4.5 kg) overhead; and push or maneuver carts.
• Ability to perform frequent pipetting and related laboratory tasks in a biological safety cabinet, including extended seated work.
• Ability to independently don, doff, and wear required PPE for prolonged periods while performing laboratory work.
• Ability to safely handle 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.
• Responsibility for safe work in accordance with EHSS procedures, including risk control, PPE use, safe handling of chemicals and biological agents, waste and emergency procedures, and participation in training and safety programs.

Nice To Haves

• Advanced degree.
• 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 to ensure effective, timely, and efficient testing and data review for in-process, release, and stability testing of clinical and commercial cell therapy drug products.
• Foster a culture of teamwork, safety, quality, and operational excellence, and embed BMS values in operational activities.
• Develop, track, trend, and report QC Analytical performance KPIs, such as turnaround time, right-first-time, and backlog; drive continuous improvement 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 promote collaboration 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 root cause analysis and effective corrective and preventive actions; and support 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 laboratory operations and represent the department in regulatory inspections and internal and external audits.
• Provide on-call and shift coverage 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.
• Eligible U.S.-based exempt employees may receive Flexible Time Off without a set accrual limit, subject to manager approval, and 11 paid company holidays annually.
• Eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation for new hires, 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, additional time-off benefits may include 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.
• Eligible employees may be offered discretionary incentive cash and stock opportunities.

What This Job Offers

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