• Ownership of all necessary processing/verification steps for patient derived clinical and commercial cellular immunotherapy products with the highest level of aseptic technique• Assist with training new personnel on aseptic practices and processing through operator qualifications and trainings• Ability to gown aseptically and work in a clean room environment (ISO 8, 7 and 5 areas) for extended periods of time• Responsible for operation on all processing days with the ability to work with automated equipment such as the Cell Saver 5 (CS5), tube welders, Dynamags, and Sepax• Verification of intermediate process days which include expertise with the wave bioreactor, and in process environmental monitoring• Maintain and prepare equipment/environment for use • Proficient in the use of production related IT systems such as SAP, Oracle EBS, Celdox,, LIMS and Syncade MES• Document all steps in the assigned Batch record in line with GMP requirements• Assist on Deviation Investigations and Inspections, and participate in qualification/ validation activities• Successful on time completion of required training curriculum comprising of the necessary Global Operating Procedures (GOPs), Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training including HSE • Perform other duties alone or in collaboration with other departments, ie. batch record review, SOP updates, process streamline improvements, safety walk-thrus, and maintenance of an “audit ready” module

• Downstream processing in the following areas: Component Prep and Buffer Prep • Setup and sterilization of components and process equipment. Monitoring equipment parameters and adjusting operational settings.• Making Buffers, Detergent, Polysorbate and Triton-X. Transfers and CIP’s involving Buffer Prep tanks, mobile tanks and pallet tanks. Ultrafiltration and Diafiltration processes.• Experienced in Fedegari Sterilization Autoclave, Girton washer equipment, ITU filter testing and calibration/operation of PH-Conductivity unit.• Record data, log activities and monitor processes according to cGMP standards.• Assist in the review of batch records for completeness and accuracy.• Certified Lilly OTJ trainer for new employees.• Organize Buffer Prep and Component Prep rooms per 5S methodology.• Adhere to all safety, environmental and quality standards according to company policy.• Participant of site Safety Team

• Trained in cGMP environments.• Monitor operations to ensure proper processing of water to meet local, State and Federal regulations.• Adjusted treatment processes and chemicals as necessary to ensure proper water quality.• Maintained logbooks, daily plant data and other operational records.• Operated water treatment plant facilities including disinfection, coagulation, and filtration equipment including pumps, valves, motors, chemical feed systems, and related equipment.• Collected water samples and tested for quality of raw, partially treated, and treated water samples using a variety of laboratory instruments.

• Maintained a database indicating the usage of equipment and tracking inspection dates• Implemented testing procedures to ensure that equipment remained operational.• Tested calibrated inspected and maintained fire protection equipment.• Developed a regular schedule for the testing of fire equipment.

• Accomplished service goals of 200+ accounts per month representing $20,000 in Revenue• Maintained standard cancelation rate by effectively communicating with clients.• Inspected property, determined the nature of problems, and implemented the most effective solutions.

• Supervised a staff of 25 officers• Set Schedules for security and parking staff• Responded to all emergency code calls, radio dispatch, mobile and foot patrols• Corresponded with Elizabeth police department during emergency situations