Senior Manager, QC Analytical-1

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.

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 verbal communication and interpersonal skills; advanced 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.
• Proficient with Excel, Visio, PowerPoint, and other common software applications.

Education/Experience/Licenses/Certifications:

• Bachelor's degree or equivalent required, preferably in science. Advanced degree preferred. An equivalent combination of education and experience may substitute.
• 10+ years of relevant laboratory work experience, preferably in a regulated environment.
• 4+ years of management and people leader experience.
• Demonstrated success working in a high-performing and results-driven environment.

Job Safety Requirements & Essential Physical Demands

• Ability to perform lifting tasks up to 20 lbs (9 kg) at floor and waist height.
• Ability to lift up to 10 lbs (4.5 kg) overhead as well as push or maneuver carts to transport materials between locations.
• 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 personal protective equipment such as but not limited to lab coat/frock, gloves, safety glasses/face shield for prolonged periods while performing laboratory work.
• Ability to safely handle and use chemical disinfectants, flammable materials, and hazardous chemicals.
• Work may involve handling of dry ice, liquid nitrogen, and cryogenically cooled materials.
• Ability to use step stools while reaching and handling materials.
• Ability to work in a Biosafety Level 2 (BSL-2) environment.
• The laboratory employee is responsible for performing work safely in accordance with EHSS procedures. This includes identifying and controlling risks, proper use of personal protective equipment (PPE), safe handling of chemicals and biological agents, compliance with waste and emergency procedures, and active participation in training and safety programs.