Lead Cell Therapy Manufacturing Specialist

Bristol Myers Squibb; Harvard (MA); Presencial; USD 55.000 - 66.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Comprehensive benefits

Flexible Time Off (FTO)

11 paid company holidays

Descripción de la vacante

Bristol Myers Squibb is seeking a Specialist, Lead Manufacturing Associate for Cell Therapy in Devens, MA. This role involves working on aseptic, cGMP cell therapy operations with a night shift, ensuring quality and safety in a fast-paced bioprocessing environment.

You will operate in a cleanroom, perform batch activities, and collaborate across shifts to maintain production schedules while adhering to regulatory standards and company policies.

Formación

• 4+ years of cGMP bioprocessing or cell therapy manufacturing experience.
• Bachelors in science or engineering, or equivalent work experience.
• Knowledge of FDA guidance and cGMP relevant to biologics/cell therapy.
• Ability to work in a cleanroom and perform aseptic processing.
• Comfort around human blood components and magnets.
• Experience with cell washing, separation, cryopreservation, and bioreactors.
• Preferred: aseptic processing in ISO 5 cabinets and universal precautions.
• Cell expansion using incubators and single-use bioreactors.

Responsabilidades

• Execute operations per SOPs and batch records.
• Document activities per protocols and SOPs.
• Solve problems and apply existing GMP solutions.
• Ensure safety, quality, and GMP compliance in all tasks.
• Set up manufacturing areas and equipment; perform commissioning.
• Collaborate with support groups to resolve technical issues.
• Support cross-functional shift teamwork to meet production goals.
• Maintain pass-down communications with Shift Managers.
• Assist investigations and write manufacturing SOPs.
• Support daily unit operations planning with production and materials flow.

Conocimientos

cGMP knowledge

Aseptic processing

Cell therapy manufacturing

Shift work capability

Team collaboration

Educación

Bachelor's degree in science or engineering

Herramientas

ISO 5 biosafety cabinets

Single-use bioreactors

Automated equipment

Descripción del empleo

Bristol Myers Squibb is seeking a Specialist, Lead Manufacturing Associate for Cell Therapy in Devens, MA. This role involves working on aseptic, cGMP cell therapy operations with a night shift, ensuring quality and safety in a fast-paced bioprocessing environment.

You will operate in a cleanroom, perform batch activities, and collaborate across shifts to maintain production schedules while adhering to regulatory standards and company policies.