Clinical Manufacturing Associate, CAR-T

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. 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:

Manufacture human blood derived cell therapies per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment of a multi-product clinical facility under the supervision of Manufacturing Management. Clinical Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team environment according to an assigned schedule. Communication of production deviations and assistance with quality investigations are required, as applicable.

This position is a member of the Cell Therapy Development and Operations (CTDO) organization.

This position is for one of the following shifts as determined by business need.

• Monday – Friday 0830-1700

Note - Start and end times are subject to change based on business demands. 

REQUIRED COMPETENCIES:  Knowledge, Skills, and Abilities:

• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
• General knowledge of cGMP/FDA regulated industry
• Basic mathematical skills
• General understanding of cGMPs
• Technical writing capability
• Proficient in MS Office applications
• Background to include an understanding of biology, chemistry, medical or clinical practices within industry
• Sufficient vision and hearing capability to work in job environment.

Education and Experience:

• Associate’s or Bachelor’s degree in related field is preferred
• Minimum of high school diploma and/or equivalent combination of education and experience is required
• 2-5 years of relevant GMP manufacturing experience. On the floor experience which demonstrates proficiency and compliant schedule adherence is highly desired. Extensive knowledge of SOPs and cGMPs and the know–how to work within a regulatory environment. Demonstrates aptitude for engineering principles and manufacturing systems. Adaptable to a fast paced, complex and ever-changing business environment

DUTIES AND RESPONSIBILITIES:

• Production of human cell therapy lots through cell culture, harvest, and cryopreservation.
• Perform operations utilizing Aseptic technique
• Become fully trained and qualified in all aspects of assigned processes
• Develop a high level of technical knowledge of project(s)
• Weigh and measure in-process materials to ensure proper quantities are added/removed.
• Adhere to the production schedule ensuring on-time, internal production logistics.
• Record production data and information in a clear, concise, format according to proper GDPs.
• Work in a team based, cross-functional environment to complete production tasks required by schedule.
• Assist tech transfers in and out of the clinical facility.
• Motivated, team consciousness individuals are needed to fulfill job requirements. 
• No direct reports will be assigned to this job role.
• Perform other tasks as assigned.

WORKING CONDITIONS (US Only):

• Must have the ability and flexibility to work assigned shift (Day, Night, Weekends and/or Holidays).
• Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to: safety shoe