NIGHT SHIFT: Senior Manufacturing Associate, Cell Therapy
Bristol Myers Squibb
Summary
BMS Cell Therapy Manufacturing is seeking a Senior Manufacturing Associate, Cell Therapy that brings enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The candidate must be goal-oriented, flexible, and able to work efficiently with safety and quality in mind. We are searching for enthusiastic, and innovative individuals with a good understanding of good manufacturing practices to support routine manufacturing operations for Cell Therapy.
Job description
Shifts Available: 6pm - 6am, rotating shift including holidays and weekends, onsite
Responsibilities
- Execute operations described in standard operating procedures and batch records
- Demonstrates strong practical and theoretical knowledge in their work
- Complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records
- Solves simple problems; takes new perspectives using existing solutions
- Performs 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
- Training others on SOPs, Work Instructions to successfully complete manufacturing operations
- Supports investigations
- Identifies innovative solutions
- 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 to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts
- Work in a cleanroom environment and perform aseptic processing; maintain manufacturing environmental conditions by performing area disinfection regimen as required to meet global Health Authority requirements
Knowledge and Skills
- 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
- Must be comfortable being exposed to human blood components
- Must be able to be in close proximity to strong magnets
- Experience in cell therapy manufacturing, including cell washing processes and automated equipment, cell separation techniques and automated equipment, cryopreservation processes and equipment
- 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
Basic 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 and relevant experience is strongly preferred
Working Conditions
- Stand and walk while operating manufacturing/computer equipment for several hours at a time
- Carry, lift, push, and/or pull up to 50 pounds several times a day
- Climb (use of stepladders or stairwells) several times a day
- Bend and kneel several times a day
- Perform overhead reaching up to 25 pounds several times a day
- Repetitive use of arms/wrists/hands
- Wear personal protective equipment (PPE) and clean room garments daily
Requirements
- High school diploma and 3+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience
- Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
- Ability to work assigned shift (Day, Night, Weekends and/or Holidays)
- Ability to work in a cleanroom environment and perform aseptic processing
- Comfortable being exposed to human blood components
- Comfortable being in close proximity to strong magnets
- Experience in cell therapy manufacturing, including cell washing processes and automated equipment
- Experience in cell separation techniques and automated equipment
- Experience in cryopreservation processes and equipment
- Bachelors in relevant science or engineering discipline and relevant experience strongly preferred
- Experience with aseptic processing in ISO 5 biosafety cabinets preferred
- Experience with universal precautions for handling human derived materials in BSL-2 containment areas preferred
- Experience with cell expansion using incubators and single use bioreactors preferred
Benefits
- Wellbeing Support
- Retirement Benefits
- Financial Protection Benefits
- Medical, Dental & Vision
- Life & Disability Insurance
- Flexible Time Off
- 11 Paid Company Holidays
- Paid Sick Leave
- Volunteer Days
- Summer Hours Flexibility
- Leaves of Absence
- Annual Global Shutdown
Company overview
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Founded in 1887 and headquartered in Princeton, New Jersey, the company operates with a unique BioPharma strategy that combines the reach and resources of a major pharmaceutical company with the entrepreneurial spirit and agility of a biotech firm. BMS focuses on transformative therapies in key therapeutic areas including oncology, hematology, immunology, cardiovascular disease, and fibrosis. The company has built a sustainable pipeline of potential therapies and leverages translational medicine and data analytics to deliver the right medicine to the right patient at the right time. With over 10,000 employees worldwide, Bristol Myers Squibb maintains a strong commitment to scientific excellence, patient-centric innovation, and global health equity through its foundation. The company's portfolio includes groundbreaking treatments such as Opdivo (nivolumab) for cancer, Eliquis (apixaban) for cardiovascular conditions, and Orencia (abatacept) for autoimmune diseases, among others.