About this role
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
The Senior Clinical Manufacturing Associate brings enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The Senior Associate must be goal-oriented, flexible, and able to work efficiently with safety and quality in mind. The Senior Associate must be enthusiastic, and innovative individuals with a good understanding of good manufacturing practices to support Clinical Manufacturing Start Up activities, and direct manufacturing operations for Clinical Cell Therapy.
Shifts Available
6am – 6pm, rotating schedule including holidays and weekends
Responsibilities will include, but are not limited to the following:
Performing Clinical patient process unit operations and supporting operations described in standard operating procedures and batch records.
Demonstrating strong practical and theoretical knowledge of work
Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
Solving simple problems; taking new perspectives using existing solutions
Identifying innovative solutions
Performing tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
Completing training assignments to ensure the necessary technical skills and knowledge.
Working in a cleanroom environment and performing aseptic processing; maintaining 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.
Referencing Batch Records, Standard Operating Procedures and Work Instructions to successfully complete manufacturing operations.
Assisting in setting up manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities.
Supporting development of manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
Supporting production planning to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts.
Supporting quality event investigations
Any related tasks as required to contribute to a new startup facility.
Additional Qualifications/Responsibilities
Knowledge, Skills & Abilities
Driven and motivated individual to learn and execute Cell Therapy Manufacturing operations.
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
Must be comfortable working with human blood components.
Must be able to be in close proximity to strong magnets.
Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.
Must be able to travel to train and develop at other BMS Sites. Travel durations typically a week or less.
Minimum Requirements
High school diploma and 3+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience
Bachelors in relevant science or engineering discipline is strongly preferred
GMP Compliance experience, knowledge of Data Integrity and ALCOA+ principles, and direct application of them.
Experience in cell therapy manufacturing, including cell washing processes, cell separation processes, cryopreservation processes, cell expansion processes using incubators and bioreactors, and automated equipment.
Experience with aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human derived materials in BSL-2 containment areas is preferred.
Working Conditions
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.
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We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview
Devens - MA - US: $33.51 - $40.61per hour