Process Specialist Jobs in Princeton, NJ

This system is potent against both hematologic and solid tumors, and in preclinical models is superior to current CAR-T in conferring long-term sustained anti-tumor function to overcome the challenges posed in solid cancer. With a solid pipeline built around a novel KIR-CAR platform, our technology has found a way to circumvent the barriers in solid cancer where other CAR therapies have limited success.

Work/Life Resources to help support topics such as parenting, housing, senior care, finances, pets, legal matters, education, emotional and mental health, and career development. The Process Management Specialist will be responsible for supporting the Voluntary Benefits Delivery Capability team for all voluntary products offered.

Senior PTS Specialists may be responsible for the authoring, collaborating, approving and the ownership/management of the following documentation: Quality Systems Change Control (tech transfer, process improvement, emergency etc.), Deviations / LIRs (complex manufacturing investigations), CAPAs (complete ownership), Action Items (management and execution) . a minimum of 8 years of related experience with a Bachelors degree; or 6 years and a Masters degree; or a PhD with 3 years experience; or equivalent experience (relevant hands-on operations experience for clinical or commercial production and/or process development experience) in the life sciences industry.

The Senior Specialist will collaborate with Global MSAT as well as Product and Development, Manufacturing Operations (MO), Supply Chain (SC), Quality Control (QC) and Quality Assurance (QA) departments while providing technical support for the resolution of validation related project deliverables, evaluation and implementation of process changes and continuous process improvement support to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.

• Support CAR-T manufacturing site Process Validation activities including, but not limited to, Aseptic Process Simulations/ Validations (APS/APV), Process Performance Qualifications (PPQ), Dynamic Airflow Visualization Studies, Container Closure Integrity Testing (CCIT), Continued Process Verification (CPV) programs and revalidation strategies to meet GMP deadlines, to ensure that the programs are compliant with regulatory agencies requirements.