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
Pre-requisites: Prior experience in Manufacturing and/or scientific/engineering education
Education:
Bachelor's degree
Associate / Medical Technical degree and 3 years of Manufacturing
Operations experience
High School diploma/GED and 2 years of Manufacturing or Operations experience.
Working Condition (US Only):
Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
Must be comfortable working with contained human blood components.
Physical dexterity sufficient to use computers and documentation.
Sufficient vision and hearing capability to work in job environment.
Ability to lift 25 pounds.
Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
Flexibility to don clean room garments and personal protective equipment (PPE).
Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions.
Reagents, chemicals, and exposure to sanitization agents are expected.
Routine exposure to human blood components. Exposure to strong magnets is likely.
Designated areas may p
Benefits
Vision insurance
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 .
Position Summary
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. Day shift structures are Quad 1 or Quad 3, 5 am-5:30 pm, Sunday through Wednesday or Wednesday through Saturday. Night shift structures are Quad 2 or Quad 4, 5 pm to 5:30 am, Sunday through Wednesday or Wednesday through Saturday. Start and end times are subject to change based on business demands.
Duties/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.
Reporting Relationship
This position reports to the Manufacturing Manager.
Bristol-myers Squibb · Summit West, NJ