Manufacturing Associate, CAR-T

Celgene Corporation - Summit, NJ (30+ days ago)4.0

Other Locations:
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

1.Purpose and Scope of Position:
Manufactures human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment 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.

Required Competencies: Knowledge/ Skills, and Abilities:
Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
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

Duties and Responsibilities:
Production of blood component lots through cell culture, harvest, and cryopreservation.
Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum.
Weighs and measures 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.
Motivated, team consciousness individuals are needed to fulfill job requirements.
Leads a team within a designated function of manufacturing, however, supervision will be managed by the shift Supervisor.
No direct reports will be assigned to this job role.
Performs other tasks as assigned.

Education and Experience:
Bachelor’s degree

or Associate/ Medical Technical degree and 2 years of Manufacturing or Operations experience

or High School diploma/GED and 4 years of Manufacturing or Operations experience.

Working Conditions:
Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
Physical dexterity sufficient to use computers and documentation.
Sufficient vision and hearing capability to work in job environment.
Ability to lift up to 25 pounds.
Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
Flexibility to don clean room garments and personal protective equipment (PPE).
Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.
Routine exposure to human blood components.
Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.