Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Serve as a lead associate in the manufacture of human blood derived components per Batch Records and Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment. Lead Manufacturing Associate adheres 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, review of executed batch records and assistance with quality investigations are required, as applicable. The Lead Manufacturing Associate works closely with the Shift Supervisor and serves to supervise the shift when the supervisor is not available. This position is for one of the following shifts, Quad 1 (Sunday – Every other Wednesday 5:00 am - 5:30 pm), Quad 2 (Sunday – Every other Wednesday 5:00 pm - 5:30 am), Quad 3 (Every other Wednesday - Saturday 5:00 am - 5:30 pm) or Quad 4 (Every other Wednesday - Saturday 5:00 pm - 5:30 am). Start and end times are subject to change based on business demands.
Duties and Responsibilities:
Production of blood component lots through any of the following areas: selection, activation, cell culture, harvest, and cryopreservation. Provide training and guidance to manufacturing associates as required.
Aseptic technique is required for most activities: tube welding, connections, and transfers, at minimum.
Weigh and measure in-process materials to ensure proper quantities are added/removed.
Perform and oversee process unit operations described in standard operating procedures and batch records.
Complete and review documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
Ensure the shift performs tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.
Serve as a trainer to maintain the shift at an acceptable qualification standard.
Lead deviation investigations and support on-time closure of deviations and CAPAs.
Work with Shift Supervisor to schedule daily unit operations that includes people, product, and material flow across multiple shifts.
Ensure associates execute scheduled activities on-time, in accordance with the production schedule.
Ensure the batch records for production data and all information are in a clear, concise, format according to proper GDPs.
Help to ensure the shift works effectively in a team based, cross-functional environment to complete all production tasks required by shift schedule.
Collaborates closely with Shift Supervisors to ensure seamless pass down and communication of operational status.
Other duties may be assigned, as necessary.
Knowledge/ Skills, and Abilities:
Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
Knowledge of cGMP/FDA regulated industry
Basic mathematical skills
Thorough understanding of cGMPs
Technical writing capability
Proficient in MS Office applications
Background to include an understanding of biology, chemistry, medical or clinical practices
Sufficient vision and hearing capability to work in job environment.
Education and Experience:
Bachelors in a biologic science or engineering discipline, or relevant work experience including a minimum 3 - 4 years of experience in cGMP biologics cell culture manufacturing. Experience in cell therapy manufacturing, or knowledge of the liso cell process is highly preferred.
Experience in any of the following areas is required:
Aseptic processing in ISO 5 biosafety cabinets.
Universal precautions for handling human derived materials in BSL-2 containment areas.
Cell expansion using incubators and single use bioreactors.
Cell washing processes and automated equipment.
Cell separation techniques and automated equipment.
Cryopreservation processes and equipment.
Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
Must have the ability to work assigned shift (Day, Night, Weekends and/or Holidays).
Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
Physical dexterity sufficient to use computers and documentation.
Climb - Required to climb (use of stepladders in production areas, or stairwells) several times a day.
Bend and Kneel - Required to bend or kneel several times a day.
Overhead work - Required to perform overhead reaching during handling of production materials/files/supplies up to 25 pounds several times a day, throughout the day.
Moving Head and Neck – Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day, throughout the day.
Twisting - Required movement of twisting waist while setting up equipment several times a day, throughout the day.
Repetitive Use - Required repetitive use of arms/wrists/hands while setting up equipment and processing several times a day, throughout the day.
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.
Must be comfortable being exposed to human blood components.
Must be able to be near strong magnets
Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.
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 the resources to pursue their goals, both at work and in their personal lives.