Newark Metro Area, New Jersey
This individual is a general contributor to the manufacturing operations team, primarily focused on producing CAR-T cell therapy products to support clinical and commercial endeavors. This broad position requires a basic understanding of GMP regulations, ability to interpret instructions, and commitment to quality. Additionally, this position requires candidates to be available for weekend work (Sat and/or Sun) at least once per month. Occasional overtime may also be required.
Responsibilities will include, but are not limited to, the following:
Manufacture clinical grade cellular therapeutic products to supply the Clinical Program:
o Execute/Implement batch records in ISO 7 & 8 clean room environments.
o Observe, practice, and promote all aspects of the GMP & GDP requirements.
o Complete and maintain aseptic processing and sterile gowning qualifications.
o Communicate with Quality Control to ensure proper handoff of process samples.
Maintain laboratory and equipment for cleanliness and compliance.
o Complete room activity, maintenance, cleaning, and equipment usage logs.
o Run daily calibration checks on equipment where appropriate, and escalate deviations.
o Perform daily, weekly, and extended cleaning of laboratory areas and equipment.
o Ensure sufficient laboratory supplies for daily laboratory operations.
Assists with development of Standard Operating Procedures (SOPs) and/or production batch records associated with new processes that are transferred from Development into Manufacturing Operations
Interact with Supply Chain, Facilities, and Development as needed to ensure smooth operation, and escalate any issues involving safety or product quality up the appropriate channels.
Collaborate with members of internal teams to drive process improvements and assist with implementation of changes by utilizing quality systems.
Reports and initiates non-conformances, and participates in follow up investigation when necessary.
B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering or related discipline with 1-3 years of relevant experience in a clinical laboratory or blood/cell culture processing environment.
Ability to work in an aseptic environment requiring successful completion of qualification program.
A basic knowledge in various computer applications. Ability to work with Microsoft Word and Excel required. Understanding of Microsoft Access or database entry is preferred.
Ability to perform frequent physical tasks with strength and mobility. Daily tasks call for extensive walking, standing and occasional lifting of heavy materials. Frequent visual demands require macroscopic and microscopic observations.
Employees must work in areas where posted Universal Precautions must be observed and practiced. Associates work daily with potentially harmful and/or hazardous agents including asphyxiating gases (nitrogen), potentially carcinogenic and/or inflammable chemical reagents and sharps.
Able to work in a team environment with several operators to complete routine tasks.
Must be flexible with work schedule as extended shift or weekend work is required.
Responds to challenges and additional projects in an understanding, positive, and objective manner.
Adaptable to dynamic conditions, work practices, and project timelines