Manager I, Manufacturing Cell Therapy - Summit West, NJ en Bristol Myers Squibb

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Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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. 
The Manufacturing Manager I leads and drives the execution of manufacturing processes according to established electronic work instructions and production records for the manufacture of cell therapies with Current Good Manufacturing Practices (cGMP’s). The Manager I is responsible for leading a team whose primary focus is on execution of manufacturing processes, technical assessment of processes, and driving a culture of safety, compliance, and innovation within their functional group. The Manager I plays a crucial role in guiding personnel in their group with technical expertise to lead troubleshooting activities, provide investigation support, analyze process/equipment data, and identify and implement process improvements. This role also creates an environment that fosters idea generation, team and cross-functional collaboration, and execution of success, repeatability, and reliability of process and staff.

Key Responsibilities:

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.