Sr Manager, Patient Material Operations (Manufacturing Shared Services)

Role Summary

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.

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.

Knowledge & Skills

• 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.

Basic Requirements

• 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.

Working Conditions

• Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
• Physical dexterity to effectively use computers and documentation.
• Vision and hearing capability to work in job environment.
• Lift maximum of 25 pounds.
• Ability to work around laboratories and controlled, enclosed, restricted areas.
• Wear required cleanroom garments and personal protective equipment in designated areas including cryo aprons, cryo gloves and face shields.
• Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
• Exposure to reagents, chemicals, exposure to sanitization agents are expected, and potential exposure to human blood components.
• Areas may prohibit food, any outside materials, cell phones, and tablets.