Bristol Myers Squibb
Sr Manager, Patient Material Operations (Manufacturing Shared Services)
Bristol Myers Squibb, Summit, New Jersey, us, 07902
Sr Manager, Patient Material Operations (Manufacturing Shared Services)
The Sr Manager, CAR T Patient Materials Operation leads a team of Managers, Team Leads and Material Handlers responsible for all processes associated with Patient Materials (Apheresis Material Receipt and Drug Product (DP) Packout to patients) within CAR T clinical and commercial operations in a cGMP multi‑cleanroom suite. The position plays a critical role in the CAR T production processes, ensuring appropriate controls, complete traceability, and efficient operations while overseeing APH receipt and DP Packout across several production areas and shifts. The role assures compliance with FDA, DEA, DOT, ISBT, CTPAT, OSHA, VAWD, cGMPs and applicable policies, regulations, and certifications, including training, documentation, standard operating procedures, and corporate policies while maintaining a culture of safety, compliance, innovation, and continuous improvement.
Shift Available: Monday – Friday, Onsite Overnight Shift, 5 p.m. – 1 a.m. (hours may change).
Responsibilities
Ensure compliant and efficient completion of production tasks for Cell Therapy products following cGMP SOPs and work instructions.
Promote safety and accountability; perform safety Gemba walks and demonstrate safe equipment operation.
Accountable for Production Records/Process Documentation; execute batch record reviews and ensure ALCOA+ principles.
Maintain hands‑on expert knowledge of each unit operation; backfill execution resources as needed.
Provide Production Scheduling team with information on resource availability and task execution.
Define team priorities, monitor performance, and report metrics in functional and site meetings.
Drive completion of training requirements; maintain trained status of all team members.
Build a high‑performing team, recruit and interview candidates, and provide ongoing feedback.
Manage Workday profiles for new hires and administer performance reviews.
Conduct regular 1‑on‑1 and skip‑level meetings for mentorship and development.
Lead troubleshooting for deviations, documenting root causes, and ensuring timely resolution.
Foster trust and collaboration with peers and stakeholders.
Define strategic projects, CAPAs, and change controls to restore area performance.
Control expenses within scope (OT, supplies, T&E).
Model BMS values of Inclusion, Accountability, Innovation, Urgency, and Passion.
Knowledge & Skills
Advanced knowledge of cGMP/GDP/Pharmaceutical regulations.
Advanced knowledge of cryopreservation, material handling, and logistics.
Strong knowledge of OSHA, DEA, USP and other relevant regulations.
Proficiency in ERP/WMS systems and analytics tools; MS Office.
Analytical, problem‑solving, critical thinking, and decision‑making skills.
Organizational and time‑management proficiency.
Strong written and verbal communication; intermediate presentation skills.
Adaptability to changing business conditions while maintaining compliance.
Ability to travel up to 15 % of the time.
Basic Requirements
Bachelor’s degree in supply chain, engineering, life sciences, information systems, business management, or related fields (equivalent experience acceptable).
5+ years in manufacturing or supply chain in a cGMP environment.
3+ years of direct supervisory or management experience.
3+ years of COI, COC, and drug product shipment understanding.
Knowledge of cell culture, cryopreservation, purification, aseptic processing or lab techniques.
Working Conditions
Requires intermittent walking and sitting; ability to sit or stand for extended periods.
Requires physical dexterity for computer use and documentation.
Vision and hearing capability to work in lab environment.
Lift up to 25 pounds.
Work in laboratories and controlled, enclosed, restricted areas.
Wear required cleanroom garments and PPE.
Prohibition on makeup, gum, nail polish, or other potential microbial sources in restricted areas.
Exposure to reagents, chemicals, sanitization agents, and human blood components expected.
Food, outside materials, cell phones, and tablets may be prohibited in restricted areas.
Compensation Overview Summit West – NJ – US $118,200 – $143,232. Additional incentive cash and stock opportunities available. Final compensation determined based on experience.
Equal Employment Opportunity Statement BMS is a diverse organization and encourages all qualified applicants regardless of color, race, religion, sex, gender identity, sexual orientation, disability, age, or any other protected class. BMS provides reasonable accommodations for qualified applicants. All hiring decisions are based on merit and job‑related criteria. All employees are required to be fully vaccinated for COVID‑19 and keep up to date with boosters. For more information, visit careers.bms.com/eeo-accessibility.
Location Summit, NJ
#J-18808-Ljbffr
Shift Available: Monday – Friday, Onsite Overnight Shift, 5 p.m. – 1 a.m. (hours may change).
Responsibilities
Ensure compliant and efficient completion of production tasks for Cell Therapy products following cGMP SOPs and work instructions.
Promote safety and accountability; perform safety Gemba walks and demonstrate safe equipment operation.
Accountable for Production Records/Process Documentation; execute batch record reviews and ensure ALCOA+ principles.
Maintain hands‑on expert knowledge of each unit operation; backfill execution resources as needed.
Provide Production Scheduling team with information on resource availability and task execution.
Define team priorities, monitor performance, and report metrics in functional and site meetings.
Drive completion of training requirements; maintain trained status of all team members.
Build a high‑performing team, recruit and interview candidates, and provide ongoing feedback.
Manage Workday profiles for new hires and administer performance reviews.
Conduct regular 1‑on‑1 and skip‑level meetings for mentorship and development.
Lead troubleshooting for deviations, documenting root causes, and ensuring timely resolution.
Foster trust and collaboration with peers and stakeholders.
Define strategic projects, CAPAs, and change controls to restore area performance.
Control expenses within scope (OT, supplies, T&E).
Model BMS values of Inclusion, Accountability, Innovation, Urgency, and Passion.
Knowledge & Skills
Advanced knowledge of cGMP/GDP/Pharmaceutical regulations.
Advanced knowledge of cryopreservation, material handling, and logistics.
Strong knowledge of OSHA, DEA, USP and other relevant regulations.
Proficiency in ERP/WMS systems and analytics tools; MS Office.
Analytical, problem‑solving, critical thinking, and decision‑making skills.
Organizational and time‑management proficiency.
Strong written and verbal communication; intermediate presentation skills.
Adaptability to changing business conditions while maintaining compliance.
Ability to travel up to 15 % of the time.
Basic Requirements
Bachelor’s degree in supply chain, engineering, life sciences, information systems, business management, or related fields (equivalent experience acceptable).
5+ years in manufacturing or supply chain in a cGMP environment.
3+ years of direct supervisory or management experience.
3+ years of COI, COC, and drug product shipment understanding.
Knowledge of cell culture, cryopreservation, purification, aseptic processing or lab techniques.
Working Conditions
Requires intermittent walking and sitting; ability to sit or stand for extended periods.
Requires physical dexterity for computer use and documentation.
Vision and hearing capability to work in lab environment.
Lift up to 25 pounds.
Work in laboratories and controlled, enclosed, restricted areas.
Wear required cleanroom garments and PPE.
Prohibition on makeup, gum, nail polish, or other potential microbial sources in restricted areas.
Exposure to reagents, chemicals, sanitization agents, and human blood components expected.
Food, outside materials, cell phones, and tablets may be prohibited in restricted areas.
Compensation Overview Summit West – NJ – US $118,200 – $143,232. Additional incentive cash and stock opportunities available. Final compensation determined based on experience.
Equal Employment Opportunity Statement BMS is a diverse organization and encourages all qualified applicants regardless of color, race, religion, sex, gender identity, sexual orientation, disability, age, or any other protected class. BMS provides reasonable accommodations for qualified applicants. All hiring decisions are based on merit and job‑related criteria. All employees are required to be fully vaccinated for COVID‑19 and keep up to date with boosters. For more information, visit careers.bms.com/eeo-accessibility.
Location Summit, NJ
#J-18808-Ljbffr