Aseptic Manufacturing Associate, Liso-cel CAR-T, Manufacturing Operations

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 Associates perform a crucial role in driving our novel cell therapy programs by supporting routine manufacturing operations. We are searching for innovative, intellectually curious individuals with a general understanding of Good Manufacturing Practices (GMPs) to support routine manufacturing operations for Cell Therapy. Successful candidates must be goal-oriented and flexible, with the ability to work effectively and efficiently on a team while demonstrating safety, quality, and GMP compliance at all times.

Shift Available:

• Sunday - Wednesday (with e/o Wednesday off), Onsite Day Shift, 5 a.m. - 5:30 p.m.

• Wednesday-Saturday (with e/o Wednesday off), Onsite Day Shift, 5 a.m. - 5:30 p.m.

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

Knowledge & Skills:

• Proven experience working on teams where collaboration and results were expected

• Proficiency in common computer tools such as word processing, spreadsheet and web-based applications

• Meticulous attention to detail and personal accountability is critical to success

• Possess excellent interpersonal skills, is attentive and approachable

• Maintain a professional and productive relationship with area management and co-workers

• Basic understanding of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred

Minimum Requirements:

• A minimum high school diploma. Associate or bachelor's degree in related field is preferred.

• 0-1 years 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.

• Must be able to work in a cleanroom environment and perform aseptic processing in ISO 5 biosafety cabinets (as assigned), which require gowning and personal protective equipment (PPE), including by not limited to: safety shoes, safety glasses, aprons, face shields, powered air purifying respirators (PAPR), lab coats, full body gowns, hairnets, gloves, and hearing protection.

• 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 materials.

• Work in areas that may have strong magnets.

• Must be able to work in a BSL2 / ML1 work environment handling human blood components.

• Work in areas with exposure to vapor phase liquid nitrogen.

• Must be able to work assigned shift (Day, Evening, Night, Weekends and/or Holidays).

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