About this job
Marker Therapeutics is seeking a Scientist or Research Associate in its Process Development group to support its ongoing efforts to develop immunotherapies for the benefit of patients with cancer. Depending on previous experience and qualifications, this individual will be expected to either lead or support the process development and process characterization of scale-up/scale-down cell manufacturing processes, including optimizing process parameters, cell concentrations and therapeutic product fill and finish technologies to advance our therapeutic programs. The successful candidate must be a team player with strong expertise in process development and must have the ability to communicate and collaborate within an interdisciplinary environment.
- Perform aseptic cell growth and manipulation procedures, such as cell isolation or enrichment, culture, cryopreservation and cell product thaw/wash.
- Perform error-free calculations to determine cell viability, dilutions, and cell concentrations.
- Possess strong experience with immunological techniques, including multi-parameter flow cytometry and ELISpot.
- Perform procedures and maintain accurate documentation in compliance with FDA’s Good Laboratory Practices as well as familiarity with Good Manufacturing Practices.
- Prepare and participate in technology transfers to CMOs and contract testing laboratories.
- Participate in the preparation of CMC sections for regulatory submissions (IND, Annual Reports, and BLA), invention disclosures, progress reports, and publications.
- Communicate research and development findings with internal and external partners
Minimal Experience and Skills
- BS, MS in Biology or a related science with 5+ years of relevant industry/academia experience.
- Ph.D. in Biology or a related science with 2+ years of relevant industry/academia experience.
- Expertise in process development and process characterization of scale-up/scale-down cell manufacturing processes, including optimizing process parameters, cell concentrations and therapeutic product fill and finish required.
- Experience with T cell-based therapies preferred.
- Attention to detail, ability to problem-solve, manage workflow, meet deadlines, communicate and work in a fast-paced team environment required.