Supervisor, Manufacturing, Cell Therapy

Position Summary

The Supervisor, Manufacturing, Cell Therapy is responsible for leading a team that executes cell therapy manufacturing processes.
Team scope is organized around Cell Therapy manufacturing unit operations such as media, selection, activation, or harvest, all of which are executed in accordance with Current Good Manufacturing Practices (cGMP’s) in both a clinical and commercial setting. The Manufacturing Operations Supervisor is responsible for managing all aspects of the manufacturing unit operation team including, but not limited to, written procedures, patient and intermediate materials, equipment, and environment of the production area, while also serving as an example within their peer group.  

NOTE: please note that the BMS internal job title is: Senior Technical Lead II, Cell Therapy.

Duties/Responsibilities

 Manage the creation, implementation and compliance for all documentation, procedures and policies related to Cell Therapy operations.

 Head of Emergency Response team

 Oversee operations within the requirements of a validated manufacturing system(s)

 Plan, assign and oversee daily operational activities associated with assigned areas of responsibility

 Maintain operating and storage areas to ensure that they are compliant, efficient, effective and safe

 Initiates change controls, notice of events, deviations and investigations

 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.

 Manage implementation and maintenance of appropriate training curricula.

 Drives right-first time initiatives and holds team accountable for compliance performance

 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 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 all stakeholders in a timely manner and in accordance with schedules and define implementation timelines

 Presence in the cell therapy manufacturing facility to participate in walk throughs, provide process troubleshooting,

Qualifications:

Preferred Experience:
7+ years of experience in cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience. 

Must have minimum of 3+ years leading a team. 

Experience in the following is highly preferred:

o Cell therapy manufacturing

o Aseptic processing in ISO 5 biosafety cabinets and universal precautions for handling human derived materials in BSL-2 / ML-1 containment areas.

o Cell expansion using incubators and single use bioreactors, Cell washing processes, Cell separation techniques and cryopreservation processes and equipment

Working Conditions:
· Must be able to stand/walk for extended periods of time.
· Must be able to work in a cleanroom environment and perform aseptic processing in ISO 5 biosafety cabinets (as needed), which require gowning and personal protective equipment (PPE), including by not limited to: safety shoes, safety glasses, aprons, face shields, powered air purifying respirators (PAPR), lab coats, full body gowns, hairnets, gloves, and hearing protection.
· Required to carry and/or lift up to 30 pounds, 15 kg, several times a day, while handling production equipment and/or
materials.
· Required to push and/or pull up to 50 pounds, 25 kg, several times a day, while handling production equipment and/or
materials.
· Work is areas that may have strong magnets.
· Must be able to work in a BSL2 / ML-1 work environment
handling human blood components
· Work in areas with exposure to vapor phase liquid nitrogen
· Must be able to work assigned shift (Day, Evening, Night,
Weekends and/or Holidays)

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