Manufacturing Associate, CAR- T - Summit West, NJ

Military Spouse Corporate Career Network•Summit West, NJ

10d•Onsite

About The Position

Our Manufacturing Associate, Cell Therapy team manufactures human blood derived components per Batch Record and Standard Operating Procedures 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.

Requirements

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
A minimum high school diploma and/or equivalent is required.
0–1 year of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education

Nice To Haves

An associate or bachelor's degree in a related field is preferred.

Responsibilities

Perform set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.
Support deviation investigations and write ups as needed.
Support on time closure of any assigned CAPAs within the designated shift.
Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum.
Aseptic qualification is required.
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.
Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements.
Works in a team based, cross-functional environment to complete production tasks required by shift schedule.
Motivated, team consciousness individuals are needed to fulfill job requirements.
Become a SME and qualified trainer within a designated function of manufacturing.
Maintain on time completion of training assignments to maintain the necessary technical skills and process knowledge.
Performs other tasks as assigned: continuous improvement projects, inspection readiness, right first-time initiatives, etc