Lead Manufacturing Associate, CAR T

Job Description

Req #: 1901735
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

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. This position is for the Weekday Shift Monday through Thursday.  Shift coverage is 7:00 am to 5:00 pm.   Start and end times are subject to change based on business demands.

2. 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.

3. 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. Acts as Shift Supervisor when Supervisor is not available.
  • Other duties may be assigned, as necessary. 
  • Performs other tasks as assigned.

4. 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.

5. 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.
  • Must be comfortable being exposed to human blood components.
  • Must be able to be in close proximity to strong magnets.
  • Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.

6. 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 and/or lift to 30 pounds several times a day while handling production equipment and/or materials
    • Required to 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.
     
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.



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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.