Bristol-Myers Squibb - Summit, NJ

posted 2 months ago

Full-time - Mid Level
Hybrid - Summit, NJ
Chemical Manufacturing

About the position

The Senior Manager, Business Operations Lead at Bristol Myers Squibb is a pivotal role responsible for overseeing the performance management and scheduling of all processes associated with Manufacturing Support Services (MSS) operations. This includes In-Process Materials Management, Patient Materials Management, GMP Cleaning, and Environmental Monitoring Sampling within the CAR T clinical and commercial operations in a cGMP multi-cleanroom environment. The position is critical in ensuring that the CAR T production processes are executed with appropriate controls, complete traceability, and efficient operations, thereby transforming the lives of patients through innovative cell therapy solutions. In this role, the Senior Manager will be tasked with scheduling, planning, and maintaining Key Performance Indicators (KPIs) while ensuring adherence to Service Level Agreements (SLAs) for various tasks within the MSS organization. Responsibilities include managing EM Sampling, GMP Cleaning, APH receipt, DP Packout, sample retrieval, sample movement, and sample storage within cryo tanks across multiple production areas and shifts. The Senior Manager will ensure compliance with all relevant regulations and policies, including FDA, DEA, DOT, ISBT, CTPAT, OSHA, VAWD, and cGMPs, while fostering a culture of safety, compliance, innovation, and continuous improvement. The position requires a proactive approach to drive timely and compliant completion of production tasks, ensuring that all activities align with the current Good Manufacturing Practices (cGMPs) and approved Standard Operating Procedures (SOPs). The Senior Manager will also be responsible for building and leading a high-performing team, conducting regular performance reviews, and mentoring team members to support their professional development. This role is essential in maintaining operational excellence and ensuring that Bristol Myers Squibb continues to lead in the field of cell therapy.

Responsibilities

  • Drive timely, 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).
  • Take personal responsibility to work safely and drive accountability and process for team members to do the same.
  • Accountable for the Process Documentation produced by the team, including executing batch record reviews and ensuring compliance with ALCOA+ principles.
  • Understand Cell Therapy production steps and sequence for each Unit Operation, role model good execution and behaviors for team members.
  • Provide the Production Scheduling team with information on the availability of production resources and task execution/progression.
  • Define team priorities and adjust as necessary to align with site and functional priorities, establishing team goals and monitoring performance.
  • Drive completion and adherence to training requirements for team members, ensuring proficiency and qualification to perform production tasks.
  • Build a high-performing team, conduct interviews, and provide feedback to current and future employees.
  • Conduct regular 1:1 meetings with team members to mentor and develop individuals.
  • Lead troubleshooting activities for the team and manage deviations, ensuring timely reporting and resolution.
  • Build trust and productive relationships with peers and stakeholders while driving collaboration across the company.
  • Define strategic projects, change controls, and CAPAs to restore area performance and ensure compliance levels.
  • Effectively control expenses within their influence.

Requirements

  • Bachelor's degree in supply chain, engineering, life sciences, information systems, business management or related fields.
  • 5+ years relevant work experience required, preferably in a regulated pharmaceutical manufacturing environment.
  • 5+ years' experience in manufacturing and supply chain areas.
  • 3+ years direct supervisor/personal management experience.
  • Advanced knowledge of cGMP/GDP/Pharmaceutical regulations and applications.
  • Strong knowledge and application of OSHA, DEA, USP and other applicable WH regulations.
  • Proficiency in ERP systems/WMS Applications, Scheduling and analytics tools.
  • Proficiency in MS Office applications.
  • Strong written and verbal communication skills.
  • Ability to adapt to changing business conditions while maintaining compliance with regulatory requirements.

Nice-to-haves

  • Experience in cell culture, cryopreservation, purification, and aseptic processing or lab techniques.
  • Intermediate presentation development and delivery skills.
  • Proficiency in analytical, problem-solving, and critical thinking skills.

Benefits

  • Competitive salary and performance-based bonuses.
  • Comprehensive health insurance plans.
  • 401(k) retirement savings plan with company matching contributions.
  • Paid time off and holidays.
  • Tuition reimbursement for further education.
  • Employee wellness programs and resources.
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