Research Associate/Senior Research Associate - Process Development
About Ernexa Therapeutics:
Ernexa Therapeutics (NASDAQ: ERNA), is a preclinical stage company developing off-the-shelf, synthetic, induced pluripotent stem cell (iPSC)-derived mesenchymal stem cell (iMSC) therapies. Our mission is to transform the treatment of cancer and autoimmune disease by developing scalable, affordable, off-the-shelf cell therapies that restore hope. Our lead product candidate, ERNA-101, expresses an IL-7_IL-15 fusion cytokine, designed to activate and regulate the immune system's response to recognize and attack cancer cells. The company’s initial focus is to develop ERNA-101 in platinum-resistant ovarian cancer (PROC). The company is also investigating ERNA-201, anti-inflammatory cytokine (IL-10)-secreting iMSCs in inflammatory/autoimmune disorders like rheumatoid arthritis.
Position description:
Ernexa Therapeutics is seeking a talented and motivated Research Associate/ Senior Research Associate to join the Process Development team. The individual will work closely with team members to develop GMP-compatible processes and procedures that will lead to the effective manufacture of our cell therapy products. This position will report into a Director who is leading the technical development of a GMP-enabling cell therapy manufacturing process and associated analytical methods. The individual will also interact cross-functionally across the organization to enable the success of Ernexa Therapeutics.
What you will do:
- Support development and optimization of manufacturing processes for induced pluripotent stem cell (iPSC) therapies, focusing on cell reprogramming, differentiation, scale-up
- Perform laboratory tasks such as maintaining and culturing iPSCs, differentating iPSCs, developing and refining protocols
- Run flow cytometry analyses and functional assays, as needed
- Assist with planning, execution, analysis, and reporting on experiments and analytic assays to support the development of a GMP process to manufacture, characterize and release stem cell therapy products.
- Compile documentation (protocols, batch records, reports) to facilitate transfer of Ernexa Therapeutics’ process and methods to external CDMO
- Collaborate closely with other functions to enable effective and successful project execution
- Organize, communicate, and present complex data sets to key stakeholders and senior management
- Assist cross-functional activities including hand-offs to various teams, compiling data, and presenting at project meetings
What you will bring:
- Bachelors or Masters degree in Cell Biology, Immunology or the biological sciences
- 0-2+ years of relevant research experience in cellular therapeutics and/or immunotherapy
- Prior experience in cell therapy, industry, and process development experience preferred
- Expertise in cell handling, cell expansion, and mammalian cell culture techniques preferred
- Experience in multi-color flow cytometry analyses, including panel design and data analysis preferred
- Expertise in cell functional assays including proliferation assessment, cytotoxicity, cytokine/chemokine
- Ability to quickly adapt and learn new skills for changing research priorities
- Flexible mind with the ability to think outside the box, creative approach to problem-solving
- Demonstrated ability to work well in a highly collaborative team environment, coordinate tasks across multiple projects to meet deadlines