Lead Manufacturing Associate CAR T Weekend Shift

Req #: 1900033
Location: Summit, New Jersey, United States
Job Category: Technical Development
Work Location: 556 Morris Avenue 07901
Organization: Manufacturing
Employee Status: Full-time
Job Type: Regular

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. This position is for the Weekend Shift: Friday, Saturday and Sunday. Weekend Day Shift coverage is 7:00am - 7:30pm and Weekend Night Shift coverage is from 7:00pm - 7:30am. 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
• 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
• Sufficient vision and hearing capability to work in job environment.

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.
• Trainer for manufacturing staff upon completion of all proficient tasks.
• Other duties may be assigned, as necessary.
• Performs other tasks as assigned.

Required Education and Experience:
Bachelor's degree plus 4 years of experience
OR Associate/ Medical Technical degree and 5 years of Manufacturing or Operations experience
OR High School diploma/GED and 6 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.
• 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.

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About Us

COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.