yoinka

Senior Manufacturing Associate, Liso-cel CAR-T, Manufacturing Operations • Value Stream CAR-T Manufacturing

Bristol-Myers Squibb

Summit West, NJFull TimeMidH-1B sponsor company
Sign in to applyVerified
Location
Summit West, NJ
Employment
Full Time
Work model
On-Site
Level
Mid
H-1B history
57 approvals (FY2023)
Posted

About this role

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. 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.   The Senior Manufacturing Associate 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: Quad 3 Wednesday - Saturday (with every other Wednesday off), Onsite Day Shift, 5 a.m. - 5:30 p.m.

Responsibilities

Execute operations as outlined in Source Governing Documents (including but not limited to: Standard Operating Procedures, Work Instructions, Batch Records, Forms) compliantly Executes transactions and process in all electronic systems and adheres to business continuity procedures Role models and leaders for the culture of compliance, safety, and team dynamics Controlled document & Deviation authoring, change impact assessment and action owner Demonstrate a strong practical and theoretical knowledge in their work Can represent department in cross-functional department collaborations May be assigned Team Lead duties as needed / delegated Complete documentation required by Source Governing Documents contemporaneously Solve complex technical problems; takes new perspectives using existing solutions Perform all tasks in a manner consistent with the safety policies, Source Governing Documents, Quality Systems, and GMP requirements including ALCOA+ Complete training assignments prior to assigned due date to ensure the necessary technical skills and knowledge Trains for proficiency in process systems and some supporting business systems, and maintains trainer qualifications Train others on Source Governing Documents to successfully complete manufacturing operations Identify and propose innovative solutions • Continues to refine and improve manufacturing process technique and improve individual operational times. Work within a controlled cleanroom environment and perform aseptic processing (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 Cross-trained into multiple manufacturing processes (as assigned) Verifies training completion prior to performing any GxP tasks Knowledge & Skills: Extensive knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing Peer-level on the floor leadership experience which demonstrates proficiency and compliant schedule adherence is highly desired Demonstrated aptitude for engineering principles and manufacturing systems Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based