Snr Manufacturing Associate
Edison-New Brunswick Metro Area, New Jersey
- B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering or related discipline with 2 - 3 years of relevant experience.
Prefer work experience in Clean Room work
Ability to read and interpret documents such as safety procedures/rules and standard operating procedures (SOPs).
- Highly motivated, willingness to acquire new skills and ability to work with minimal supervision
Must have strong engineering or scientific knowledge appropriate for processing clinical grade cellular therapeutics
Ability to consistently perform various manual production duties and techniques on time sensitive material with accurate and precise manipulations. Example: performing cell separations or preparation of cryopreservation.
Knowledge of cGMPs and SOP development would be advantageous
- Collaborate with members of Cell Process Development, Quality Control, and Quality Assurance to develop cellular therapeutic processes and products.
Execute/implement Clinical Production batch records for the following areas: cell culture, cell harvesting, tissue processing (placenta), cryopreservation.
Maintain and deliver sufficient supply of appropriate grade material for clinical studies in accordance with timelines, and participate in clinical supply campaigns
Perform tasks in the absence of supervisor
Coordinate daily laboratory tasks
Contributes input toward the revision of Standard Operating Procedures (SOPs)
Daily review of batch records
Prepare and maintain cell culture reagents and media
Ensure sufficient laboratory supplies for daily laboratory operations
Ensure proper operation and perform routine maintenance of all laboratory equipment
Assist other staff to complete tasks
Follow SOP s associated with processing of Clinical Grade Cellular Therapeutics.
Responsible for entering processing data into Batch Records