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This position is based at our Juno Manufacturing Plant (JuMP) in Bothell, Washington.
The primary focus of the Manufacturing Associate role will be cellular therapeutic manufacturing at JuMP during process transfers, routine production, and technology improvements. The key deliverables for this role are (1) helping to establish the JuMP manufacturing operations and (2) completing production assignments with a high quality and timely output.
- Performing patient process unit operations and support operations described in standard operating procedures and batch records.
- Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
- Performing tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.
- Completing training assignments to ensure the necessary technical skills and knowledge.
- Assisting in setting up manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities.
- Writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
- Working with production planning, Sr. Manufacturing Manager, and lead associates to establish daily unit operations schedule that includes people, product, and material flow across multiple shifts.
- Bachelors in relevant science or engineering discipline, or equivalent in work experience.
- 0-2 years of experience in cGMP biologics cell culture manufacturing, experience in cell therapy manufacturing preferred.
- 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).
- Must be able to work in a cleanroom environment and perform aseptic processing; 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.
- Must be comfortable in a clean room environment, which is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.
- Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
- Must be comfortable being exposed to human blood components.
- Must be able to be in close proximity to strong magnets.
- Must be willing to work 5:00 am - 5:30 pm or 5:00 pm - 5:30 am three to four times a week.
- Experience in cell therapy manufacturing
- Experience in the following preferred:
- 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.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. During higher times of processing these activities may increase.
- Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time, throughout the day.
- Carrying weight, Pushing, Pulling Lifting - Required to carry, lift, push, and/or pull up to 50 pounds several times a day while handling production equipment and/or materials.
- 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.
- Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.