Joul

Minimum 3 years relevant experience in GMP biologic/cell therapy manufacturing technical or process support.. Familiarity with cell therapy processes and cGMP is strongly preferred.. Experience working with external parties and/or cross-functional teams Responsibilities: Participation in process tech transfer and incoming process changes, communicate the changes to applicable departments, and lead the process improvement projects at the site.. Author, and approve protocol and reports in accordance with internal and external regulatory expectations (APS, Engineering, Tech Transfer).. Performs tech transfer facility fitness, gap analysis, and risk assessment when on-boarding new programs.

investigator

Title: Investigator, MS&T Location: Princeton NJ Duration: 3 months Hours: MON-FRI 8AM TO 5PM On Site Education: • BSc and/or Advanced degree in Science or Chem/Bio Engineering • Advanced degree(s) preferred Requirement: • Minimum 5 years of industry experience.  Must Have Gene/Cell Therapy Manufacturing experience • Minimum 3 years relevant experience in GMP biologic/cell therapy manufacturing technical or process support. • Scientific understanding in bioprocessing principles. Familiarity with cell therapy processes and cGMP is strongly preferred. • Experience in Process qualification, validation • Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities is a huge plus • Experience with program management software and tools are a plus • Experience working with external parties and/or cross-functional teams Responsibilities: Participation in process tech transfer and incoming process changes, communicate the changes to applicable departments, and lead the process improvement projects at the site. The MS&T Specialist works to identify and drive continuous improvements to the manufacturing process. • Functions as a technology and process subject matter expert. • Provides on-the-floor and on-site technical support to manufacturing when necessary. • Author, review and approve, as needed, various documents (eg. Batch records, SOPs). • Author, and approve protocol and reports in accordance with internal and external regulatory expectations (APS, Engineering, Tech Transfer). • Analyze and summarize manufacturing data to support impact assessments and investigations. • Owner of change controls for process and procedure changes. • Lead and executes CAPA system investigations. • Leads technology transfer efforts for new processes and product implementation. • Performs tech transfer facility fitness, gap analysis, and risk assessment when on-boarding new programs. • Applies continuous improvement tools to identify and close procedural and compliance gaps • Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts. m3

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