Position Summary:The Lead Manufacturing Associate, Cell Therapy brings enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The Lead Manufacturing Associate must be goal-oriented, flexible, and able to work efficiently with safety and quality in mind, with a good understanding of good manufacturing practices to support routine manufacturing operations for Cell Therapy.
Shifts Available:6am - 6pm, rotating schedule including holidays and weekends
Responsibilities:- 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.
- Working in a cleanroom environment and performing 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.
- Referencing Batch Records, Standard Operating Procedures and Work Instructions to successfully complete manufacturing operations.
- Demonstrating strong practical and theoretical knowledge of work.
- Solving complex problems; taking new perspectives using existing solutions
- Identifying innovation solutions
- Setting up manufacturing areas and equipment/fixtures; performing facility and equipment commissioning activities.
- Working closely with Manufacturing Managers to ensure seamless pass down and communication of operational status.
- Working with production planning and leadership to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts.
- Helping ensure the shift works effectively in a team-based, cross-functional environment to complete all production tasks required by shift schedule.
- Collaborating with support groups on recommendations and solving technical problems.
- Supporting development of manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
- Supporting quality event investigations
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.
Knowledge and Skills:- Driven and motivated 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 being exposed to 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.
Minimum Requirements:- 4+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience.
- Bachelors in relevant science or engineering discipline, or equivalent in work experience.
- Experience in cell therapy manufacturing techniques, 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.
BMSCART#LI-ONSITEWe 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: $43.84 - $53.12per hour
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We WorkWhere you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
