Bristol Myers Squibb
manufacturing
Supervisor,Manufacturing,CellTherapy
“Supervisor, Manufacturing, Cell Therapy at Bristol Myers Squibb. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement, cGMP cell therapy manufacturing, bioprocessing manufacturing, cGMP, cGMP requirements, leading a team. leading a team that executes cell therapy manufacturing processes. managing all aspects of the manufacturing unit operation team including, but not limited to, written procedures”
What You'll Achieve.
compliance performance; Ensure that operating and storage areas are compliant, efficient, effective and safe; prevent deviations and maintain a compliant environment; Drives right-first time initiatives
Industry & Context.
process troubleshooting; strategic and operational issues; deviations; investigations; corrective and preventative actions; deviation responses
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 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)
What They're Looking For.
Must Have
minimum of 3+ years leading a team
Nice to Have
7+ years of experience in cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience, Cell therapy manufacturing, Aseptic processing in ISO 5 biosafety cabinets and universal precautions for handling human derived materials in BSL-2 / ML-1 containment areas, Cell expansion using incubators and single use bioreactors, Cell washing processes, Cell separation techniques and cryopreservation processes and equipment
What You'll Do.
leading a team that executes cell therapy manufacturing processes
managing all aspects of the manufacturing unit operation team including
patient and intermediate materials
and environment of the production area
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)
assign and oversee daily operational activities associated with assigned areas of responsibility
Maintain operating and storage areas to ensure that they are compliant
Initiates change controls
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
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
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
How You'll Work.
Team & Collaboration
cross-functional coordination; stakeholder management; coordinate, communicate, and provide Operations project information and activities status to all stakeholders; Create an environment of teamwork, open communication
Communication Scope
open communication; communicate Operations project information and activities status to all stakeholders
Process & Methodology
resource planning, implementation, timelines
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