Edison-New Brunswick Metro Area, NJ
Bachelors in a biologic science or engineering discipline, or relevant work experience including 3-6+ years of experience in cGMP biologics cell culture manufacturing. Experience in cell therapy manufacturing, or knowledge of the liso cell process is highly preferred.
Day Shift -and Night Shifts avaialble 4 / 12 hour days (5A to 5P) including 1 weekend day
- Oversee and lead a team of associates in the manufacture of human blood derived components per Batch Records and Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment. Shift Supervisors 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, review of executed batch records and assistance with quality investigations are required, as applicable.
- Knowledge/ Skills, and Abilities: - 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 - Sufficient vision and hearing capability to work in job environment.
Duties and Responsibilities: - Performance manage, train and oversee a team of associates in the production of blood component lots through any of the following areas: selection, activation, cell culture, harvest, and cryopreservation. - Aseptic technique is required for most activities: tube welding, connections, and transfers, at minimum. - Weigh and measure in-process materials to ensure proper quantities are added/removed. - Perform and oversee process unit operations described in standard operating procedures and batch records. - Complete and review documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. - Ensure the shift performs tasks in a manner consistent with the safety policies, quality systems, and GMP requirements. - Ensure all associates on the shift complete training assignments to ensure the necessary technical skills and knowledge. Serve as a trainer to maintain the shift at an acceptable qualification standard. - Lead deviation investigations and support on-time closure of deviations and CAPAs. - Write manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements - Work with production planning and area Management to establish daily unit operations schedule that includes people, product, and material flow across multiple shifts. - Ensure associates execute scheduled activities on-time, in accordance with the production schedule. - Ensure the batch records for production data and all information are in a clear, concise, format according to proper GDPs. - Ensure the shift works effectively in a team based, cross-functional environment to complete all production tasks required by shift schedule. - Collaborates closely with other Shift Supervisors to ensure seamless pass down and communication of operational status. - Other duties may be assigned, as necessary.
Required Education and Experience:
Bachelors in a biologic science or engineering discipline, or relevant work experience including 3-6+ years of experience in cGMP biologics cell culture manufacturing. Experience in cell therapy manufacturing, or knowledge of the liso cell process is highly preferred. Experience in any of the following areas is required: i. Aseptic processing in ISO 5 biosafety cabinets. ii. Universal precautions for handling human derived materials in BSL-2 containment areas. iii. Cell expansion using incubators and single use bioreactors. iv. Cell washing processes and automated equipment. v. Cell separation techniques and automated equipment. vi. Cryopreservation processes and equipment. Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. Must have the ability to work assigned shift (Day, Night, Weekends and/or Holidays).