Senior Manager, Cryo Operations, Infrastructure Management

About the position

The Senior Manager, Cryo Operations, Infrastructure Management is responsible for processes associated with maintaining, procuring, and ensuring proper operation of equipment for short/long term storage of cryogenically frozen Sample vials, 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 Senior Manager interfaces with other functions of MSS such as Sample Vial Handling, 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 process documentation produced for infrastructure management as well required business records. Execute/perform LIMS, MRP or Electronic Batch Record review for inventory management documentation following ALCOA+ principles.
• Understand Cell Therapy production steps and maintenance/selection/usage of proper equipment & functionality of practices to enable production execution. Maintain hands-on expert knowledge of each Unit Operation, role model good execution and behaviors for team members.
• Responsible for providing the required site teams and site leadership with information (daily, weekly, monthly and annually) on the condition of cryogenic storage, production equipment resources and drive task execution/progression for the required strategic levers.
• Actively adjust activities as necessary to align with site and or functional priorities, measure and assess the performance/completion of the area infrastructure management tasks 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 equipment usage training requirements and assess appropriate level of training for self and team members on relevant topics, completes their training plan on time and ensures proficiency and qualification to perform the production tasks.
• Build a high performing team of Managers and Operators by helping to 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, decision making and accountability.
• 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, peers and management team 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.

Requirements

• Bachelor's degree.
• 5+ years' relevant work experience.
• 3+ years' relevant leadership experience.

Nice-to-haves

• Bachelor's degree in supply chain, engineering, life sciences, information systems, business management or related fields.
• 5+ years relevant work experience, preferably in a regulated pharmaceutical manufacturing environment working in manufacturing and supply chain areas.
• 3+ years direct supervisor / personal management experience.
• Understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.

Benefits

• Competitive benefits, services and programs that provide resources to pursue goals at work and in personal lives.