Manufacturing Associate, CAR-T
Bristol-Myers Squibb
Manufacturing Associate, CAR-T
Job Description
Perform set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation. Support deviation investigations and write ups as needed. Support on time closure of any assigned CAPAs within the designated shift. Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum. Aseptic qualification is required. Weighs and measures in-process materials to ensure proper quantities are added/removed. Adheres to the production schedule ensuring on-time, internal production logistics. Records production data and information in a clear, concise, format according to proper GDPs. Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements. Works in a team based, cross-functional environment to complete production tasks required by shift schedule. Motivated, team consciousness individuals are needed to fulfill job requirements. Become a SME and qualified trainer within a designated function of manufacturing. Supervision will be managed by the shift Supervisor or designated Team Lead. Maintain on time completion of training assignments to maintain the necessary technical skills and process knowledge. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Supporting People with Disabilities 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. Bachelor's degree and no prior Manufacturing Operations experience. Or Associate/ Medical Technical degree and 2 years of Manufacturing Operations experience. Or High School diploma/GED and 4 years of Manufacturing Operations experience. Ability to lift 25 pounds.
About the Role/Company
- The company supports people with disabilities
Key Responsibilities
- Perform set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation
- Support deviation investigations and write ups as needed
- Support on time closure of any assigned CAPAs within the designated shift
- 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 GDPs
- 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
- Become a SME and qualified trainer within a designated function of manufacturing
- Maintain on time completion of training assignments to maintain the necessary technical skills and process knowledge
Required Qualifications
- Bachelor's degree and no prior Manufacturing Operations experience
- Associate/Medical Technical degree and 2 years of Manufacturing Operations experience
- High School diploma/GED and 4 years of Manufacturing Operations experience
- 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
- Background to include an understanding of biology, chemistry, medical or clinical practices
- Aseptic qualification
Skills Required
- Aseptic technique for tube welding, connections, and transfers
- Technical writing capability
- Proficient in MS Office applications
- Motivated and team-conscious attitude
- Ability to lift 25 pounds
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Additional Requirements
- Supervision managed by the shift Supervisor or designated Team Lead
Locations
- Summit West NJ, United States
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
50,000 - 80,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Aseptic technique for tube welding, connections, and transfersintermediate
- Technical writing capabilityintermediate
- Proficient in MS Office applicationsintermediate
- Motivated and team-conscious attitudeintermediate
- Ability to lift 25 poundsintermediate
Required Qualifications
- Bachelor's degree and no prior Manufacturing Operations experience (experience)
- Associate/Medical Technical degree and 2 years of Manufacturing Operations experience (experience)
- High School diploma/GED and 4 years of Manufacturing Operations experience (experience)
- Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique (experience)
- Knowledge of cGMP/FDA regulated industry (experience)
- Basic mathematical skills (experience)
- General understanding of cGMPs (experience)
- Background to include an understanding of biology, chemistry, medical or clinical practices (experience)
- Aseptic qualification (experience)
Responsibilities
- Perform set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation
- Support deviation investigations and write ups as needed
- Support on time closure of any assigned CAPAs within the designated shift
- 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 GDPs
- 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
- Become a SME and qualified trainer within a designated function of manufacturing
- Maintain on time completion of training assignments to maintain the necessary technical skills and process knowledge
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Manufacturing Associate, CAR-T
Bristol-Myers Squibb
Manufacturing Associate, CAR-T
Job Description
Perform set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation. Support deviation investigations and write ups as needed. Support on time closure of any assigned CAPAs within the designated shift. Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum. Aseptic qualification is required. Weighs and measures in-process materials to ensure proper quantities are added/removed. Adheres to the production schedule ensuring on-time, internal production logistics. Records production data and information in a clear, concise, format according to proper GDPs. Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements. Works in a team based, cross-functional environment to complete production tasks required by shift schedule. Motivated, team consciousness individuals are needed to fulfill job requirements. Become a SME and qualified trainer within a designated function of manufacturing. Supervision will be managed by the shift Supervisor or designated Team Lead. Maintain on time completion of training assignments to maintain the necessary technical skills and process knowledge. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Supporting People with Disabilities 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. Bachelor's degree and no prior Manufacturing Operations experience. Or Associate/ Medical Technical degree and 2 years of Manufacturing Operations experience. Or High School diploma/GED and 4 years of Manufacturing Operations experience. Ability to lift 25 pounds.
About the Role/Company
- The company supports people with disabilities
Key Responsibilities
- Perform set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation
- Support deviation investigations and write ups as needed
- Support on time closure of any assigned CAPAs within the designated shift
- 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 GDPs
- 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
- Become a SME and qualified trainer within a designated function of manufacturing
- Maintain on time completion of training assignments to maintain the necessary technical skills and process knowledge
Required Qualifications
- Bachelor's degree and no prior Manufacturing Operations experience
- Associate/Medical Technical degree and 2 years of Manufacturing Operations experience
- High School diploma/GED and 4 years of Manufacturing Operations experience
- 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
- Background to include an understanding of biology, chemistry, medical or clinical practices
- Aseptic qualification
Skills Required
- Aseptic technique for tube welding, connections, and transfers
- Technical writing capability
- Proficient in MS Office applications
- Motivated and team-conscious attitude
- Ability to lift 25 pounds
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Additional Requirements
- Supervision managed by the shift Supervisor or designated Team Lead
Locations
- Summit West NJ, United States
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
50,000 - 80,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Aseptic technique for tube welding, connections, and transfersintermediate
- Technical writing capabilityintermediate
- Proficient in MS Office applicationsintermediate
- Motivated and team-conscious attitudeintermediate
- Ability to lift 25 poundsintermediate
Required Qualifications
- Bachelor's degree and no prior Manufacturing Operations experience (experience)
- Associate/Medical Technical degree and 2 years of Manufacturing Operations experience (experience)
- High School diploma/GED and 4 years of Manufacturing Operations experience (experience)
- Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique (experience)
- Knowledge of cGMP/FDA regulated industry (experience)
- Basic mathematical skills (experience)
- General understanding of cGMPs (experience)
- Background to include an understanding of biology, chemistry, medical or clinical practices (experience)
- Aseptic qualification (experience)
Responsibilities
- Perform set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation
- Support deviation investigations and write ups as needed
- Support on time closure of any assigned CAPAs within the designated shift
- 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 GDPs
- 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
- Become a SME and qualified trainer within a designated function of manufacturing
- Maintain on time completion of training assignments to maintain the necessary technical skills and process knowledge
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
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