Clinical Manufacturing Associate CAR T

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

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. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable.

Duties and Responsibilities

Production of human cell therapy lots through cell culture, harvest, and cryopreservation.

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.

Adheres to the production schedule ensuring on-time, internal production logistics.

Records production data and information in a clear, concise, format according to proper GDPs.

Works in a team based, cross-functional environment to complete production tasks required by shift 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.

Performs other tasks as assigned.

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

Technical writing capability

Proficient in MS Office applications

Background to include an understanding of biology, chemistry, medical or clinical practices within industry

Education and Experience

Bachelor's degree in an applicable science/engineering discipline

Working Conditions

Must have the ability 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 shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.

Must be able to 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.

Must be comfortable in a clean room environment, which is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.

Must have the ability to work around laboratories and controlled, enclosed, restricted areas.

Mustbe comfortable being exposed to human blood components.

Must be able to be in close proximity to strong magnets.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. During higher times of processing these activities may increase.

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.

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 the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1520963_EN

Updated: 2020-04-16 00:00:00.000 UTC

Location: Warren,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com