Manufacturing Associate, liso cel CAR T, Manufacturing Operations

Bristol Myers Squibb • Summit, NJ

2d • $28 - $34 • Onsite

About The Position

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. Quad 3, 5 am-5:30 pm, Wednesday through Saturday. Start and end times are subject to change based on business demands.

Requirements

• 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
• Prior experience in Manufacturing and/or scientific/engineering education
• Bachelor’s degree
• Associate / Medical Technical degree and 2 years of Manufacturing Operations experience
• High School diploma/GED and 3 years of Manufacturing or Operations 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.
• 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.
• Performs other tasks as assigned: continuous improvement projects, inspection readiness, right first-time initiatives, etc.

Benefits

• Medical, pharmacy, dental, and vision care.
• Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees