Operator, Upstream Manufacturing, Contractor

Job Locations US-NJ-Florham Park
ID
2021-1588
Category
Technical Operations/ Manufacturing
Type
Contract

Overview

Celularity is seeking a dynamic individual to join a motivated team of Upstream Manufacturing operators for the daily manufacture of cell stock, media, reagents, etc. for multiple cell therapy products in support of the company’s clinical stage platforms. Leveraging Celularity’s new, state-of-the-art cGMP capable facility, this position will make use of existing innovations and future technologies to meet and exceed manufacturing demand.

Responsibilities

  • Join a team of highly qualified operators to establish ongoing supply of cell stock in support of the company’s cell therapy products. Provide metrics and KPI data to management and maintain forecasted inventory to ensure supplies are available for time critical processing.

 

  • Participate in the daily preparation and maintenance of cell culture reagents and bulk media manufacturing for off the shelf/on-demand media readiness.   

 

  • Ability to operate in classified manufacturing environments with ability to gown appropriately for manufacturing activities.

 

  • Utilize equipment and associated batch records to aseptically prepare media and donor stock. Ensure the proper operation and performance of manufacturing equipment and accurately complete equipment logbooks and associated records.

 

  • Execution and daily completion of multiple batch records. Ability to adhere to Good Documentation Practices. Consistently perform various laboratory duties and techniques on time sensitive material with accurate and precise product and media manipulations. 

 

  • Work cohesively with cross-functional teams in support of operational efficiency, flexibility, and assurance of timely completion of all manufactured donor stock material and media. Maintain and deliver sufficient supply of bulk media and cell isolation products for pivotal clinical studies in accordance with company timelines and participate in clinical supply campaigns.

 

  • Engage in training activities and technical process transfers for existing and future products. Execute protocols to support and improve Upstream Manufacturing Operations. As needed, provide daily technical updates to Technical Operations management.

 

  • Participate in the manufacturing environment cleaning program and work to assure all manufacturing suites, equipment and critical environments are maintained on schedule.

Qualifications

Minimum Qualifications (Must have)

 

  • BS degree in Biology, Bioengineering or related scientific discipline
  • Experience with cells and/or tissue manufacturing. Understanding of human cell and tissue-based therapies
  • Strong organizational and time management skills
  • Capability to work well in a team environment
  • Excellent verbal and written communication skills as well as strong focus and attention to detail.
  • Ability to perform frequent physical tasks with strength and mobility. Daily tasks call for routine walking and standing in cleanroom environments and occasional lifting of heavy materials.
  • Flexible scheduling required

 

Preferred Qualifications 

  • 6 months - 2 years’ relevant experience within clinical manufacturing and operation within cGMP environments.
  • Understanding of federal regulations for Quality Systems (21CFR820) and GMP manufacturing (21CFR 210,211).
  • Demonstrated scientific creativity, technical proficiency, and knowledge of scientific concepts
  • Understanding of upstream manufacturing operations and related gowning
  • Knowledge of GxP regulations (GTP, GDP, cGMP)
  • Experience in a fast-paced, scientific start-up environment
  • Dynamic individual with the ability to communicate and engage others
  • Independent and self-starting
  • Eager and adaptable

 

Working Conditions

 

  • Position primarily operates for extended periods of time in classified laboratory environments. Daily gowning in company provided scrubs, PPE and laboratory attire.
  • Fast paced, start-up environment, which may periodically require work beyond standard business hours and may include weekend work.
  • Must be able to lift and transport at least 25 pounds
  • Handling of potentially biohazardous material (human cells, tissues, etc.).

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