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PDS Tech Inc Senior Manufacturing Operator in Princeton, New Jersey

PDS Tech, Inc. is seeking a Senior Manufacturing Operator in Princeton, NJ

What will you do?

  • Execution of manufacturing batch records, work instructions and/or SOPs, with minimal instruction on a day-to-day basis and a focus on proactive right the first time executions. Assist with batch record reconciliation and timely documentation.

  • Performance of all manufacturing activities in clean room (ISO 7) environment with specialized sterile gowning.

  • Execution of cell manufacturing and cell processing activities in closed systems and maintaining aseptic technique during processing to ensure highest integrity, viability and sterility of cellular product until release.

  • Work as a part of the team to execute all necessary GMP runs for cell manufacturing in an accurate and timely manner

  • Perform accurate and error-free calculations of cell concentrations, cell and media dilutions and cell viability throughout the entire cell manufacturing process workflow.

  • Able to execute all Department functions, such as maintaining suite, supplies, equipment, logbooks and data in accordance with site SOPs and policies.

  • Acts as On-The-Job-Trainer for a variety of job functions

  • Documentation of all activities to meet cGMP requirements. Execute document reviews and revisions. Daily record review, tasks, and databases. Actively provide feedback.

  • Critical evaluation of processes, including foresight and thinking ahead.

  • Complete preventative maintenance and work notifications tasks on time. Perform equipment testing and routine trouble-shooting.

  • Ensure tasks are executed with a method of prioritization - interpret production schedules and complete tasks accordingly.

  • Perform timely consumption of materials and completion of quality documentation in appropriate systems

  • Identify deviations, aid in investigations/root cause analysis, and provide input on major/critical deviations.

  • Work to complete documentation of deviations and events in appropriate systems

  • Execute validation protocols with minimal supervision or direction

  • Participate in cross-functional teams to complete projects

How will you get here?

  • BS or MS in biological science or engineering discipline

  • Equivalent combinations of education, training, and relevant work experience may be considered.

  • 2-5 years of relevant cGMP experience in a manufacturing pharmaceutical/biotech environment or related areas

  • Experience in aseptic cell culture processing in IOS 5 biosafety cabinets while using universal precautions for handling of human-derived materials preferred

  • Experience in cell therapy manufacturing required

  • Experience in cell therapy automation technologies, closed system culture vessels, cell washers, cell separation technologies for autologous/allogenic product manipulation preferred

  • Experience in handling, propagation, isolation, activation and cryopreservation of human primary cells including T cells preferred

  • Strict adherence to SOPs, GMP regulations, FDA guidance and ability to accurately complete associated documentation required

Knowledge, Skills, Abilities

  • Strong written and oral communication skills

  • Understanding why and not just the how of processes and practices

  • Knowledge of cGMP practices required

  • Knowledge of deviation investigations preferred

  • Knowledge of cell culture and aseptic techniques strongly preferred

  • MS Office

  • Strong math skills

  • Strong prioritization skills

  • Detail oriented

  • Results driven

  • Strong communication skills with ability to read, write, and communicate in English

  • Effectively multi-task

  • Able to work independently and as part of a team

  • Able to recognize problems developing, not just occurring

  • Ability to travel up to 20%

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.