Our client is a privately held, clinical-stage, pre-IPO biotechnology company pioneering the development of vaccines through its investigational proprietary technology platform. 

The Process Development Scientist, Cell Therapy Operations will be responsible for development of manufacturing processes of cell therapy products at ITI. This position requires a highly motivated scientist with good laboratory skills, who will work on process development initiatives, process characterization, data recording, management of process technical documents, and technology transfer activities to GMP manufacturing. Prior experience in cell therapy process automation technologies will be preferred. The successful candidate will have competency in the application of statistical methods, tools for data analysis, writing technical reports, and data presentation in internal and external meetings. The candidate will report to Associate Director, Cell Therapy Operations.

Essential Functions

• Support the establishment of the Process Development Laboratory, including identification, evaluation, and installation of equipment.
• Design and execute process automation and support tech transfer of processes to GMP manufacturing.
• Critically analyze data from processes and author technical reports and standard operating procedures.
• Summarize and present data in group meetings and contribute to group discussions.
• Drive continuous improvement activities. Evaluate new technologies and innovate novel approaches to improve existing methods.
• Author and review technical and regulatory documents in support of CMC regulatory submissions (IND, BLA, etc.).
• Engage with both internal and external partners in the support of Process Development, preclinical, and clinical development of cell and gene therapies.
• Will interact directly with R&D, Quality, Regulatory Affairs and Project Management as an integral part of the product development team.
• Will interact with external organizations (e.g., Contract Manufacturing, Contract Testing, Contract Development, Equipment vendors)
• May have direct supervisory responsibilities of Research

Experience

• Scientist I: Ph.D. in appropriate discipline (e.g., molecular biology, biochemistry, immunology) with 1-3 years of work experience (Scientist I) preferably in cell therapy.
• Scientist II: Ph.D. in appropriate discipline (e.g., molecular biology, biochemistry, immunology) with 3-5 years of work experience preferably in cell therapy.
• D. requirement may be offset with significant appropriate and directly relevant experience
• Understanding of immunology and cellular biology with application to development of cellular processing methods.
• Experience and competency with the cell therapy process automation technologies such as Sepax, Lovo, CliniMACS, Prodigy.
• Experience using transfection techniques.
• Experience working with human immune cells is preferable.
• Competency in the application of statistical methods and tools for data analysis.
• Ability to work independently or as a team member to meet goals and commitments.
• Strong written and verbal communication skills are required. Experience translating complex scientific concepts and data into reports, presentations and CMC filings is required.