Manufacturing Associate, Manufacturing Operations - Summit West, NJ
VetJobs, Summit, NJ, United States
Manufacturing Associate, Cell Therapy
At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
Our Manufacturing Associate, Cell Therapy team manufactures human blood-derived components per Batch Record and Standard Operating Procedures 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: Wednesday - Saturday (with e/o Wednesday off), Onsite Overnight Shift, 5 p.m. - 5:30 a.m.*Start and end times are subject to change based on business demands.
Responsibilities:
Learn and execute Cell Therapy Manufacturing operations compliantly.
Execute operations as outlined in Source Governing Documents (including but not limited to: Standard Operating Procedures, Work Instructions, Batch Records, Forms).
Executes transactions and process in all electronic systems and adheres to business continuity processes.
Prioritizes safety of self and others.
Reports safety events within 24 hours.
Immediately escalates any/all issues that may impact compliance or safety of self and/or others.
Complete documentation required by Source Governing Documents contemporaneously.
Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements including ALCOA+.
Complete training assignments prior to assigned due date to ensure necessary technical skills and knowledge.
Train for proficiency in process systems and some supporting business systems.
Execute the daily unit operations schedule, that includes people, product, and material flow across multiple shifts.
Work within a control cleanroom environment and execute aseptic processing procedures (as assigned).
Maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.
Continues to refine and improve manufacturing process technique to improve individual operational times.
Verifies training completion prior to performing any GxP tasks.
Author Manufacturing operating procedures that are technically sound, promote effective and efficient operations and comply with cGMP requirements.
At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
Our Manufacturing Associate, Cell Therapy team manufactures human blood-derived components per Batch Record and Standard Operating Procedures 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: Wednesday - Saturday (with e/o Wednesday off), Onsite Overnight Shift, 5 p.m. - 5:30 a.m.*Start and end times are subject to change based on business demands.
Responsibilities:
Learn and execute Cell Therapy Manufacturing operations compliantly.
Execute operations as outlined in Source Governing Documents (including but not limited to: Standard Operating Procedures, Work Instructions, Batch Records, Forms).
Executes transactions and process in all electronic systems and adheres to business continuity processes.
Prioritizes safety of self and others.
Reports safety events within 24 hours.
Immediately escalates any/all issues that may impact compliance or safety of self and/or others.
Complete documentation required by Source Governing Documents contemporaneously.
Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements including ALCOA+.
Complete training assignments prior to assigned due date to ensure necessary technical skills and knowledge.
Train for proficiency in process systems and some supporting business systems.
Execute the daily unit operations schedule, that includes people, product, and material flow across multiple shifts.
Work within a control cleanroom environment and execute aseptic processing procedures (as assigned).
Maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.
Continues to refine and improve manufacturing process technique to improve individual operational times.
Verifies training completion prior to performing any GxP tasks.
Author Manufacturing operating procedures that are technically sound, promote effective and efficient operations and comply with cGMP requirements.