Team Lead, Patient Materials Operations

Bristol Myers Squibb • Summit, NJ

2d

About The Position

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. The Team Lead, Patient Materials Operations tactically leads a team of Associates responsible for all processes associated with Patient Materials (Apheresis Material Receipt, Drug Product Packout, Sample Retrieval, Sample Movements and Sample Storage) within CAR T clinical and commercial operations in a cGMP multicleanroom suite. This position plays a critical role in the CAR T production processes ensuring appropriate controls, complete traceability, and efficient operations. The Team Lead PMO, leads APH receipt, DP Packout and sample movements across several production areas and multiple shifts. The position assures individual and group compliance with all 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

Requirements

• Associate’s degree in supply chain, engineering, life sciences, information systems, business management or related fields
• 3+ years relevant work experience required, preferably in a regulated pharmaceutical manufacturing environment
• 1+ years’ experience in manufacturing, and supply chain areas
• 1+ years direct supervisor / personal management experience
• Understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
• An equivalent combination of education, experience and training may substitute
• Knowledge of cGMP/GDP/Pharmaceutical regulations and applications - Knowledge of material handling and logistics including best industry practices, application of principles, concepts, practices, standards, validation, and qualification
• Knowledge and application of OSHA, DEA, USP and other applicable WH regulations
• Knowledge of ERP systems / WMS Applications and analytics tools - Knowledge in MS Office applications
• Knowledge in analytical, problem-solving, critical thinking skills and strong situational decision making
• Exhibit organizational and time management skills
• Exhibit written and verbal communication skills
• Ability to adapt to changing business conditions while maintaining appropriate level of controls and compliance with regulatory requirements
• Ability to travel 5% of time

Responsibilities

• Accountable for completion of production tasks for Cell Therapy products to support product Value Stream outputs according to Current Good Manufacturing Practices (cGMP’s) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Take personal responsibility to work safely and drive accountability and process for team members to do the same. Perform regular safety Gemba walks, identify the hazards associated with team’s work and demonstrate safe behavior when operating and maintaining equipment to prevent injuries or incidents.
• Accountable for the Production Records/Process Documentation produced by the team. Perform batch record reviews (BRR) or Electronic Batch Record review by exception and ensure that all documentation produced by the team follows the ALCOA+ principles.
• Perform Cell Therapy production steps to maintain hands-on expert knowledge of each Unit Operation, role model good execution and behaviors for team members and if necessary, able to backfill execution resources to meet the production schedule.
• Responsible for providing the team leadership with tactical information (daily, weekly monthly) on the availability production resources and task execution/progression. Actively execute team priorities and adjust as necessary to align with team leadership defined site and or functional priorities, assist with measurement and assessment of the completion of the team production activities and goals. Provides data for performance metrics and goal progress daily, weekly, monthly in site/team Tier meetings.
• Enable completion, adherence to training requirements for team members, completes their training plan on time and ensures proficiency and qualification to perform the production tasks. Enforces team training due dates and informs the trained status of all team members by ensuring appropriate time is allocated to training activities.
• Support building of a high performing team of Operators and provide meaningful feedback to current and future employees/leadership and HR partners. Enable a culture of ethics and decision making. Assist with feedback within the performance review process, driving performance, giving recognition when deserved and continuous feedback to improve performance and ensure behavior aligned with the BMS values. Conduct routine 1:1 meeting with team members to mentor, develop/motivate individuals, and assist team members with their professional development.
• Execute tasks per troubleshooting activities for the team and assist with closure of deviations occurring in area, capture the relevant background information in a timely fashion. Assist with clear, concise, and factually complete description of events that led to the deviation and enter the deviation record information in the system. Report out deviation progress, assist with id of repeat causes of deviations and drive on time deviation closure.
• Help build trust and productive relationships with peers and stakeholders while driving collaboration across the company and external partners. Participate in projects, change controls and CAPAs as required to restore area performance and ensure optimal compliance levels. Identify strategic and operational issues both internally and externally, provide proposals, assist with solutions, and meet time commitments to resolve. Act as a change agent in a fast-paced environment to promote flexibility, creativity, and accountability.
• Participate on defined control of expenses for team (OT, Supplies, T&E). Lead by example, role model leadership behaviors and drives their team to adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency and Passion.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
• Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree