Sr. Manager, CAR T Warehouse Operations

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The Senior Manager, CAR T Warehouse Operations leads a high performing team responsible for all processes associated with material receipts, movement, storage, and distribution within CAR T clinical and commercial operations. This position plays a critical role in the CAR T warehousing processes ensuring appropriate controls, complete traceability, and efficient operations. The Senior Manager leads different operations across multiple warehouse locations and multiple shifts while providing strategic and operational efficiencies, cost savings, inventory accuracy and leadership actions. The position assures individual 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. The Senior Manager will maintain a compliant, effective, and efficient operation that meets or exceeds site goals and objectives.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

• Advanced knowledge of warehouse operations including best industry practices, application of principles, concepts, practices, standards, validation, and qualification
• Advanced knowledge of cGMP/GDP/Pharmaceutical regulations
• Advanced knowledge of Quality systems
• Advanced knowledge of OSHA, DEA, USP and other applicable WH regulations
• Advanced proficiency in ERP systems / WMS Applications and analytics tools
• Advanced analytical, problem-solving, and critical thinking skills
• Advance project management experience handling multiple projects simultaneously
• Advanced organizational and time management skills
• Advanced proficiency in data analytics and process mapping applications (Excel, Visio, SharePoint)
• Advanced proficiency in MS Office applications
• Excellent interpersonal, verbal, presentation, and written communication skills
• Lead continues improvement and innovation opportunities within the GMP Warehouse and 3rd Party Warehouse, providing input into broader materials management improvement opportunities
• Advanced problem-solving aptitude with attention to detail
• Understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
• Ability to work independently
• Ability to work collaboratively as a team member
• Ability to interpret / write technical documents
• Ability to travel 5% - 10% of time

Education and Experience:

• Bachelor’s degree in supply chain, engineering, life sciences, information systems, business management or related fields.
• 10+ years of relevant work experience required, preferably in the pharmaceutical or related industry.
• 10+ years’ experience in warehousing, manufacturing, and supply chain areas.
• 10+ years direct supervisor / personal management experience
• 5+ years of leadership experience preferred.
• Understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.
• An equivalent combination of education, experience and training may substitute

DUTIES AND RESPONSIBILITIES:

• Operating within the requirements of a validated warehouse management system, manage daily operational activities associated with the receiving of Apheresis and PBMC shipments, all inbound movement / receipt and storage of materials through the CAR T supply chain network, kitting operations along with the preparation of drug product shipments
  
  • Maintain shipping, receiving, staging, kitting and storage areas that are compliant, efficient, effective, and safe.
  • Engage with various groups to manage and expedite receipt along with ensuring appropriate sampling / inspection of incoming materials
  • Manage the creation, implementation and compliance for all documentation, procedures and policies
  • Identify strategic and operational issues both internally and externally, develop proposals, outline solutions, and provide time commitments and resources
  • Lead and manage the development of corrective and preventative actions, deviation responses and investigations for warehouse operations

• Oversee a team of Managers and Supervisors daily including all training, performance evaluations and personnel career development
  
  • Manage implementation and maintenance of appropriate training curricula
  • Build a collaborative environment that fosters decisive decision making and accountability
  • Fosters a culture of high ethics and compliance
  • Create an environment of teamwork, open communication, and a sense of urgency
  • Provide a safe and healthy work environment for staff within areas and ensure compliance with all appropriate policies and regulations
  • Promote and engage team in safety training program

• Efficiently coordinates, communicates, and provides essential Warehouse Operations project information and activities status to Development, Clinical, Planning, Manufacturing, Quality Assurance / Operations, Global Supply, and other associated functions in a timely manner in accordance with schedules and defined implementation timelines
• Build trust and productive relationships with peers and stakeholders
• Drive collaboration across the company and external partners
• Manage cycle counting process
• Interface with Cost Accounting and Internal Audits to coordinate, manage and perform regular physical inventory counts as scheduled
• Lead multi-functional and multi-location teams through project identification and implementation for both short and long-term projects
• Identify strategic and operational issues both internally and externally, develop proposals, outline solutions, and provide time commitments and resources
• Act as a change agent in a fast-paced environment to promote flexibility, creativity, and accountability
• Deliver business results through timely and quality decision making

CAPA & Deviation Management

• Collaborate with cross-functional system partners and represent Warehouse Operations in all CAPA & Deviation reviews and communication.
• Investigate events and effectively prepare communication to address questions and issues.
• Leads internal organization and project teams to advance departmental quality matters (including but not limited to deviations, CAPAs, change control evaluations).
• Critically review investigations, interpret results and work with SMEs to generate conclusions consistent with quality risk management principles.

Process Mapping

• Develop business process models, process maps, process outlines and documentation to assist in evaluating and optimizing business operations.
• Seek and support continuous process improvement projects both within the department and across site collaborative initiatives.
• Collaborate with site and departmental management to develop business requirements for business process improvements within site operations.
• Manage projects across all of site supply chain operations.
• Performs business impact assessment on changes to business systems (ERP, MES, boundary systems) and processes.
• Understand manufacturing processes and the implementation within the global ERP and boundary systems (i.e., configuration and master data, including, but not limited to, items, recipes, routings, formulas, process instructions and process variables).
• Collaborate internal and external departments to gather business requirements, prioritize, develop, design, create data source definitions and deliver reports from ERP or Ad Hoc reporting tool(s).

Communication

• Collects, analyzes, and reports key information impacting the site supply chain operations.
• Collaborate with departmental leads to create, manage, and publish KPIs and metrics.
• Lead the development of a communication plan that keeps internal stakeholders appropriately informed of departmental initiatives and progress reports.
• Create and manage departmental SharePoint sites to facilitate collaboration and communication across Cellular Therapy Organizations.

WORKING CONDITIONS (US Only):

• Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
• Physical dexterity sufficient to use computers and documentation.
• Sufficient vision and hearing capability to work in job environment.
• Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
• Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
• Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
• Flexibility to don clean room garments and personal protective equipment (PPE).
• Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.
• Routine exposure to human blood components.
• Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.

BMSCART

VETERAN

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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