Clinical Manufacturing Associate II

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

PURPOSE AND SCOPE OF POSITION:

BMS Cell Therapy Manufacturing seeks an Associate II within Clinical Manufacturing 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 Clinical Manufacturing Start Up activities, and direct manufacturing operations for Clinical Cell Therapy.

**Monday - Friday, core business hours**

DUTIES AND RESPONSIBILITIES:

• Performing patient process unit operations and support operations described in standard operating procedures and batch records. 
• Demonstrates strong practical and theoretical knowledge in their work
• 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. 
• Collaborates with support groups on recommendations and solving technical and operational problems.
• Identifies innovative solutions
• Assisting in setting up manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities. 
• Training others on SOPs, Work Instructions to successfully complete manufacturing operations. 
• Executing 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 (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. 
• Any related tasks as required to contribute to a new startup facility.

REQUIRED COMPETENCIES:  Knowledge, Skills, and Abilities:

Education:

• High school diploma and 2+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience
• Bachelors in relevant science or engineering discipline and relevant experience is preferred

Experience

• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.
• 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 being exposed to human blood components.
• Must be able to be in close proximity to strong magnets.
• Must be open to travel.

Preferred Qualifications:

• Experience in cell therapy manufacturing, including Cell washing processes and automated equipment. Cell separation techniques and automated equipment. Cryopreservation processes and equipment.
• Aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human derived materials in BSL-2 containment areas.

PHYSICAL DEMANDS: 

• 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 - Requir