Senior Clinical Manufacturing Associate, Cell Therapy Manufacturing
Bristol Myers Squibb
Summary
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, with a good understanding of good manufacturing practices to support Clinical Manufacturing Start Up activities and direct manufacturing operations for Clinical Cell Therapy.
Job description
Responsibilities
- Performing Clinical patient process unit operations and supporting operations described in standard operating procedures and batch records
- Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records
- Solving simple problems and identifying innovative solutions
- Performing tasks consistent with safety policies, quality systems, and cGMP requirements
- Completing training assignments to ensure necessary technical skills and knowledge
- Working in a cleanroom environment and performing aseptic processing; maintaining manufacturing environmental conditions
- Referencing Batch Records, Standard Operating Procedures and Work Instructions to complete manufacturing operations
- Assisting in setting up manufacturing areas and equipment/fixtures
- Performing facility and equipment commissioning activities
- Supporting development of manufacturing operating procedures that comply with cGMP requirements
- Supporting production planning to execute daily unit operations schedule across multiple shifts
- Supporting quality event investigations
Knowledge, Skills & Abilities
- Driven and motivated individual to learn and execute Cell Therapy Manufacturing operations
- Ability to work assigned shift (Day, Night, Weekends and/or Holidays)
- Ability to work in a cleanroom environment and perform aseptic processing
- Comfortable working with human blood components
- Comfortable being in close proximity to strong magnets
- Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred
- Ability to travel to train and develop at other BMS Sites
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, cell separation, cryopreservation, cell expansion using incubators and bioreactors, and automated equipment
- Experience with aseptic processing in ISO 5 biosafety cabinets and universal precautions for handling human derived materials in BSL-2 containment areas is preferred
Requirements
- High school diploma and 3+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience
- GMP Compliance experience, knowledge of Data Integrity and ALCOA+ principles, and direct application of them
- Experience in cell therapy manufacturing, including cell washing, cell separation, cryopreservation, cell expansion using incubators and bioreactors, and automated equipment
- Ability to work in a cleanroom environment and perform aseptic processing
- Ability to work assigned shift (Day, Night, Weekends and/or Holidays)
- Comfortable working with human blood components
- Comfortable being in close proximity to strong magnets
- Ability to travel to train and develop at other BMS Sites
- Bachelors in relevant science or engineering discipline is strongly preferred
- Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred
- Experience with aseptic processing in ISO 5 biosafety cabinets and universal precautions for handling human derived materials in BSL-2 containment areas is preferred
Benefits
- Medical, Dental & Vision
- Life & Disability Insurance
- Retirement Benefits
- Flexible Time Off
- 11 Paid Company Holidays
- Paid Sick Leave
- Volunteer Days
- Summer Hours Flexibility
- 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.