Bristol Myers Squibb
Manufacturing Team Lead, Liso-cel CAR-T, Manufacturing Operations
Bristol Myers Squibb, Summit, New Jersey, us, 07902
Manufacturing Team Lead, Liso‑cel CAR‑T, Manufacturing Operations
Manufactures human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable.
Shift Available
Sunday - Wednesday (with e/o Wednesday off), Onsite Night Shift, 5 p.m. - 5 30 a.m.
Responsibilities
Oversee set‑up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.
Lead deviation investigations and write‑ups as needed.
Accountable for on‑time closure of any assigned CAPAs within the designated shift.
Perform aseptic technique for tube most activities welding, connections, and transfers, at minimum.
Maintain aseptic qualification.
Weigh and measure in‑process materials to ensure proper quantities are added/removed.
Adhere to the production schedule ensuring on‑time, internal production logistics.
Record production data and information in a clear, concise format according to proper GMPs.
Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements.
Work in a team‑based, cross‑functional environment to complete production tasks required by shift schedule.
Motivated, team‑conscious individuals are needed to fulfill job requirements.
Is a SME and qualified trainer within a designated function of manufacturing.
Team Lead is responsible for the designated area within the shift.
Shift supervision will be managed by the shift Supervisor, but Team Lead will act as Supervisor when needed.
Maintain on‑time completion of training assignments and those of the associates in the designated area to ensure the necessary technical skills and process knowledge required to execute operations in a GMP compliant manner.
Knowledge & Skills
Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.
Knowledge of cGMP/FDA regulated industry.
Basic mathematical skills.
General understanding of cGMPs.
Technical writing capability.
Proficient in MS Office applications.
Background to include an understanding of biology, chemistry, medical or clinical practices.
Pre‑requisites Senior Associate in Manufacturing.
Basic Requirements
Bachelor's degree and 4 years of experience in cell therapy in Biopharmaceutical operations.
Or Associate / Medical Technical degree and 6+ years of Manufacturing Operations experience.
Or High School diploma/GED and 8+ years of Manufacturing or Operations experience.
Working Conditions
Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
Must be comfortable working with contained human blood components.
Physical dexterity sufficient to use computers and documentation.
Sufficient vision and hearing capability to work in job environment.
Ability to lift 25 pounds.
Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
Flexibility to don clean room garments and personal protective equipment (PPE).
Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions.
Reagents, chemicals, and exposure to sanitization agents are expected.
Routine exposure to human blood components. Exposure to strong magnets is likely.
Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.
Compensation Overview Summit West - NJ - US $38.12 - $46.20 per hour. The starting compensation range for this role is listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings include medical, pharmacy, dental, vision care and wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well‑being resources and a 401(k) are also available. Work‑life programs include paid national holidays, optional holidays, up to 120 hours of paid vacation, and flexible hours.
For full EEO statement, refer to our Equal Employment Opportunity statement at https://careers.bms.com/eeo-accessibility.
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Shift Available
Sunday - Wednesday (with e/o Wednesday off), Onsite Night Shift, 5 p.m. - 5 30 a.m.
Responsibilities
Oversee set‑up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.
Lead deviation investigations and write‑ups as needed.
Accountable for on‑time closure of any assigned CAPAs within the designated shift.
Perform aseptic technique for tube most activities welding, connections, and transfers, at minimum.
Maintain aseptic qualification.
Weigh and measure in‑process materials to ensure proper quantities are added/removed.
Adhere to the production schedule ensuring on‑time, internal production logistics.
Record production data and information in a clear, concise format according to proper GMPs.
Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements.
Work in a team‑based, cross‑functional environment to complete production tasks required by shift schedule.
Motivated, team‑conscious individuals are needed to fulfill job requirements.
Is a SME and qualified trainer within a designated function of manufacturing.
Team Lead is responsible for the designated area within the shift.
Shift supervision will be managed by the shift Supervisor, but Team Lead will act as Supervisor when needed.
Maintain on‑time completion of training assignments and those of the associates in the designated area to ensure the necessary technical skills and process knowledge required to execute operations in a GMP compliant manner.
Knowledge & Skills
Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.
Knowledge of cGMP/FDA regulated industry.
Basic mathematical skills.
General understanding of cGMPs.
Technical writing capability.
Proficient in MS Office applications.
Background to include an understanding of biology, chemistry, medical or clinical practices.
Pre‑requisites Senior Associate in Manufacturing.
Basic Requirements
Bachelor's degree and 4 years of experience in cell therapy in Biopharmaceutical operations.
Or Associate / Medical Technical degree and 6+ years of Manufacturing Operations experience.
Or High School diploma/GED and 8+ years of Manufacturing or Operations experience.
Working Conditions
Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
Must be comfortable working with contained human blood components.
Physical dexterity sufficient to use computers and documentation.
Sufficient vision and hearing capability to work in job environment.
Ability to lift 25 pounds.
Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
Flexibility to don clean room garments and personal protective equipment (PPE).
Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions.
Reagents, chemicals, and exposure to sanitization agents are expected.
Routine exposure to human blood components. Exposure to strong magnets is likely.
Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.
Compensation Overview Summit West - NJ - US $38.12 - $46.20 per hour. The starting compensation range for this role is listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings include medical, pharmacy, dental, vision care and wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well‑being resources and a 401(k) are also available. Work‑life programs include paid national holidays, optional holidays, up to 120 hours of paid vacation, and flexible hours.
For full EEO statement, refer to our Equal Employment Opportunity statement at https://careers.bms.com/eeo-accessibility.
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