Associate, Manufacturing Operations
Newark Metro Area, NJ
Manufacture clinical grade cellular therapeutic products to supply CCT Clinical Program.
Ensure smooth day-to-day operation of clinical production.
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
Proper handling and storage of products into designated freezer or liquid nitrogen tank
Operation of laboratory processing equipment, including Biosafety Cabinets and Clean Rooms
Maintain a clean and safe work environment in accordance with policies/procedures and OSHA safe practices
REQUIRED: B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering or related discipline with 2 - 3 years of relevant experience. Will consider entry level right out of school
Prefer work experience in Clean Room work (Mgr will give priority to such candidates).
Ability to read and interpret documents such as safety procedures/rules and standard operating procedures (SOPs). Must be able to communicate effectively with other CCT functional areas, and accrediting and regulatory agencies.
Must have excellent organization skills and ability to handle multiple tasks
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
Excellent verbal and written communication skills
A basic knowledge in computer applications including basic MS Word and Excel required.
Ability to perform frequent physical tasks with strength and mobility. Daily tasks call for extensive walking, standing and occasional lifting of heavy materials that have a weight of 30 40 lbs maximum. Frequent visual demands require macroscopic and microscopic observations.
Contractors must work in areas where posted Biological Universal Precautions must be observed and practiced. There is repeated contact with potential infectious blood products with subsequent risks of acquired infections. Associates work daily with potentially harmful and/or hazardous agents including asphyxiating gases (nitrogen), potentially carcinogenic and/or inflammable chemical reagents and sharps.