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Clinical Manufacturing Associate - Trenton, United States - System One Holdings, LLC
Description
Job Title :
Clinical Manufacturing Associate
Location :
Warren, NJ
Type:
Contract
Responsibilities
Production of blood component lots through cell culture, harvest, and cryopreservation.
Aseptic technique
Become fully trained and qualified in all aspects of assigned processes
Develop a high level of technical knowledge of project(s)
Weigh and measure in-process materials to ensure proper quantities are added/removed.
Adhere to the production schedule ensuring on-time, internal production logistics.
Record production data and information in a clear, concise, format according to proper GDPs.
Work in a team based, cross-functional environment to complete production tasks required by shift schedule.
Assist tech transfers in and out of the clinical facility.
Requirements
Bachelors degree in an applicable science or engineering field and a minimum of 2 years relevant experience
Advanced understanding of cell culture
Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
Experience within cGMP/FDA regulated industry
Basic mathematical skills
Technical writing capability
Proficient in MS Office applications
Background to include an understanding and application within industry of biology, chemistry, medical or clinical practices
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
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