Manager , Manufacturing Operations

Position Summary

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”, a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits.

This is work that transforms the lives of patients, and the careers of those who do it.

• Manages the creation, implementation and compliance of all Source Governing Documents (including but not limited to: Standard Operating Procedures, Work Instructions, Batch Records, Forms) related to cell therapy operations for self and others
• Oversee operations within the requirements of a validated manufacturing system(s)
• Plan, assign resources and oversee daily operational activities associated with assigned areas of responsibility while controlling costs
• Maintain operating and storage areas to ensure that they are compliant, efficient, effective, safe and always inspection ready
• Drives right-first-time initiatives and holds team accountable for compliance performance. Generates solutions for compliance issues.
• Prepares, gains alignment and implements Change Controls
• Completes MRB slides and presents at MRB meetings as needed
• Initiates change controls, notice of events, deviations and investigations and drives actions to closure as assigned
• Evaluates team performance and drives continuous improvement of cost, quality, safety, culture and delivery.
• Identify strategic and operational issues to prevent deviations and maintain a compliant environment. Lead and manage the development of corrective and preventative actions, deviation responses and investigations
• Verify manufacturing associates and team leads are fully trained on respective curricula to maintain compliance prior to performance any GxP task.
• Create an environment of teamwork, open communication, and a sense of urgency. Foster a culture of safety and compliance that embraces safety in the work environment, including psychological safety, and the safety of the patients by compliance with company procedures and policies, and cGMP requirements
• Efficiently coordinate, communicate, and provide Operations project information and activities status to Planning, Manufacturing, Quality Assurance / Operations, Global Supply and other associated functions in a timely manner and in accordance with schedules and defined implementation timelines
• Presence in the cell therapy manufacturing facility to participate in walk throughs, provide process troubleshooting, participate in event triages, and have direct contact with manufacturing personnel in order to provide timely, effective coaching.
• Oversee operators on daily basis as they:
  Perform unit and support operations described in Source Governing Documents in a safe and GMP compliant manner
• Complete documentation contemporaneously required by Source Governing Documents.
• Maintain training compliance by completing all training assignments to ensure the necessary technical skills and knowledge
• Assist in the setup of manufacturing areas and equipment/fixtures, facility and equipment commissioning, and qualification and validation activities
• Write manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
• Hire, mentor and develop exceptional people. Conduct effective performance reviews with supporting documentation and identify opportunities for career growth for manufacturing associates. Immediately address performance issues through document coaching / feedback as required.

Sr. Manager or Associate Director

• Education:
  
  Bachelors in relevant science or engineering discipline, or equivalent in work experience
• Experience:
  
  5+ years of experience in cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience with 2 years leadership experience (i.e. lead or equivalent) including performance management…