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Sr. / Lead Manufacturing Associate, CAR-T

Req #: 1800334
Location: Summit, Summit US
Job Category: Manufacturing/Technical Operations
Work Location: 556 Morris Avenue CELSUMWEST 07901
Organization:
Schedule: 0
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:US- NJ- Summit West

Description

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.

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
  • 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.

#LI-POST

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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