Sr Manager, Patient Material Operations (Manufacturing Shared Services)

Celgene • Summit, NJ

65d • Onsite

About The Position

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 . At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. 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. This position plays a critical role in the CAR T production processes ensuring appropriate controls, complete traceability, and efficient operations. The Sr Manager leads APH receipt and DP Packout across several production areas and multiple shifts (future 12hr/7d Operation). 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. Shift Available: Monday - Friday, Onsite Overnight Shift, 5 p.m. - 1 a.m. Hours are subject to change due to business needs.

Requirements

• Advanced knowledge of cGMP/GDP/Pharmaceutical regulations and applications.
• Advanced knowledge of cryopreservation, material handling and logistics including best industry practices, application of principles, concepts, practices, standards, validation, and qualification.
• Strong knowledge and application of OSHA, DEA, USP and other applicable WH regulations.
• Proficiency in ERP systems / WMS Applications and analytics tools.
• Proficiency in system and application use for business operations.
• Proficiency in MS Office applications.
• Proficiency in analytical, problem-solving, critical thinking skills and strong situational decision making.
• Proficient organizational and time management skills.
• Strong written and verbal communication skills.
• Intermediate presentation development and delivery skills.
• Ability to adapt to changing business conditions while maintaining appropriate level of controls and compliance with regulatory requirements.
• Ability to travel 15% of time.
• Bachelor's degree in supply chain, engineering, life sciences, information systems, business management or related fields. An equivalent combination of education, experience and training may substitute.
• 5+ years' experience in manufacturing and/or supply chain areas within a cGMP environment.
• 3+ years direct supervisor / personal management experience.
• 3+ years of understanding COI, COC, and drug product shipment.
• Understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.

Responsibilities

• Ensure compliant and efficient 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.
• Execute/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 Production Scheduling team with information (daily, weekly monthly) on the availability production resources and task execution/progression.
• Actively define team priorities and adjust as necessary to align with site and or functional priorities, establish the team goals and monitor, measure and assess the performance/completion of the team production activities and goals.
• Reports out performance metrics and goal progress daily, weekly, monthly in functional and site Tier meetings and the site metric control plans.
• Drive completion, adherence to training requirements and assess appropriate level of training for team members, completes their training plan on time and ensures proficiency and qualification to perform the production tasks.
• Monitors team training due dates and maintains the trained status of all team members by ensuring appropriate time is allocated to training activities.
• Building of a high performing team of Managers, Operators and helps recruit exceptional people, conducts interviews/reviews candidate suitability, and provides meaningful feedback to current and future employees/leadership, Talent Acquisition and HR partners.
• Build a culture of ethics and decision making.
• Responsible for creating/managing Workday profiles for all new hired staff and administering the performance review process, differentiating performance, giving recognition when deserved and continuous feedback to improve performance and ensure behavior not aligned with the BMS values.
• Conduct regular 1:1 meetings/skip levels with team members to mentor, develop/motivate individuals, and enable team members with their professional development.
• Lead troubleshooting activities for the team and provide ownership of Deviations occurring in area, capture the relevant background and potential causal factor information in a timely fashion.
• Author 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, helps maintain proper deviation metrics, identify repeat causes of deviations and closes out all deviations on time.
• Build trust and productive relationships with peers and stakeholders while driving collaboration across the company and external partners
• Define strategic 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, develop proposals, outline solutions, and provide time commitments and resources to resolve.
• Act as a change agent in a fast-paced environment to promote flexibility, creativity, and accountability.
• Effectively control expenses within their influence (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

• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
• Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
• Parental, caregiver, bereavement, and military leave.
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
• Other perks like tuition reimbursement and a recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees