Manufacturing Associate - CAR-T
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Responsibilities
- Create inclusive culture that builds relationships with support groups
- 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
- Knowledge & Skills:
- Knowledge of cGMP/FDA regulated industry
- Basic mathematical skills
- General understanding of cGMPs
- Technical writing capability
- Proficient in MS Office applications
- Inventory control and/or management
- Background to include an understanding of biology, chemistry, medical or clinical practices
- Basic Requirements:
- A minimum high school diploma and/or equivalent is required. An associate or bachelor's degree in a related field is preferred
- 0-1 year of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education
- Working Conditions:
- Must be able to stand/walk for extended periods of time
- 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 material
Benefits
Additional Information
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . 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, CAR-T 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: Sunday - Wednesday (with e/o Wednesday off), Onsite Day shift, 5 a.m. - 5:30 pm.
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