Director/Assoc. Director of Process Development

<p><strong>Director/Assoc. Director of Process Development</strong></p> <p><strong>About Kernal Biologics, Inc. </strong></p> <p>Kernal Bio is a venture-backed therapeutics company engineering cells inside the body using AI-designed, selective mRNA and targeted LNP technology. By developing in vivo CAR-T therapies, Kernal Bio is advancing precision treatments for autoimmune diseases and blood cancers. The company was founded by experts from MIT, Harvard, Merck, and BMS, and its leadership team brings a track record of three FDA-approved therapies and over 120 patents. With support from leading investors, including Hummingbird Ventures, Amgen Ventures, Y Combinator, and HBM. Kernal Bio is transforming the future of cell therapy design and delivery.</p> <p> </p> <p><strong>Job Summary:</strong></p> <p>Kernal Bio is seeking a highly motivated and experienced Director/Associate Director of Process Development with expertise in mRNA manufacturing to contribute to the development of its mRNA 2.0 platform for therapeutic applications. The successful candidate will inspire and lead a team responsible for the process development of mRNA-targeted LNP therapeutics. Proficiency in mRNA-tLNP chemistry, analytics, and biology workflows, coupled with experience in antibody-decorated lipid nanoparticle scale-up is essential for this role.</p> <p><strong>Responsibilities:</strong></p> <ul> <li>Lead the process development team and guide the company’s drug substance and drug product process development.</li> <li>Work with senior management to expand the company’s CMC team</li> <li>Stay up-to-date on pertinent literature and prepare technical reports and white papers for internal use</li> <li>Oversee the synthesis, purification, and formulation of routine mRNA-tLNP products for preclinical studies</li> <li>Establish and optimize the company’s mRNA-tLNP manufacturing scale-up capability </li> <li>Help develop scalable strategies for downstream product purification </li> <li>Conduct process development studies using the design of experiments (DOE) approach.</li> <li>Help with routine analytical and bioanalytical tasks such as HPLC, qPCR, ELISA, fragment analysis, cell-based assays, fluorescence, and flow cytometry.</li> <li>Coordinate <em>in vivo</em> studies in rodents for process quality validation </li> <li>Collaborate with the RD teams and support experiments on Kernal Bio’s RD pipeline</li> <li>Assist in IP filings and manuscript preparations</li> <li>Select and manage CROs and CDMOs (with some travel if/when needed).</li> <li>Finalize and transfer the process for IND enabling studies and GMP manufacturing campaigns</li> <li>Collaborate with academic partners for external preclinical studies</li> <li>Prepare CMC sections for regulatory filings</li> <li>Oversee the COGS reduction strategy for in vivo CAR-T product</li> <li>Present scientific findings internally and externally at critical scientific conferences and industry events</li> <li>Analyze, summarize, and present experimental results to team members and management</li> <li>Contribute to technical discussions intellectual property related to the development and application of Kernal’s proprietary technologies</li> <li>Explore new technologies and methods to optimize current processes in a fast-paced research environment </li> <li>Maintain up-to-date records and communicate results to team members in written technical reports and oral presentations</li> <li>Participate in experimental design and troubleshooting efforts</li> <li>Interpret, summarize experimental data and maintain excellent laboratory notebooks</li> </ul> <p><strong>Requirements:</strong></p> <ul> <li>PhD/MS/BS in Chemical Engineering, Biomedical Engineering, Chemistry, Biology, Molecular Biology, or a similar field</li> <li>8 years of industry experience in CMC field with 5 years of academic or industry experience in nucleic acid and/or lipid nanoparticle manufacturing</li> <li>Attention to detail, ability to multi-task, a ... (truncated, view full listing at source)