Vice President, Chemistry, Manufacturing & Controls (CMC) – mRNA & Targeted LNP Therapeutics

About Kernal Biologics, Inc. 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. Job Summary: Kernal Bio is seeking a highly motivated and experienced Vice President of Chemistry Manufacturing and Controls (VP of CMC) with expertise in mRNA-tLNP 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 manufacturing, process development, and analytical development of mRNA-LNP therapeutics. Proficiency in mRNA-tLNP chemistry and biology workflows, coupled with experience in Good Manufacturing Practices (GMP) mRNA-tLNP manufacturing, is essential for this role. Responsibilities: Lead and scale the CMC organization , defining strategy for mRNA drug substance and targeted LNP (tLNP) drug product from preclinical through clinical development Oversee development and scale-up of mRNA IVT manufacturing , purification processes, and tLNP formulation , ensuring robust, reproducible performance Build and drive internal manufacturing capabilities , while strategically leveraging and managing CDMOs/CROs for scale and flexibility Drive process development (DOE-driven) , optimization, and tech transfer to support GMP manufacturing campaigns (internal and external) Establish and manage analytical and bioanalytical strategies (e.g., HPLC, qPCR, ELISA, cell-based assays) to support product characterization, potency, and release Define and execute CMC regulatory strategy , including authoring IND/CTA sections and supporting agency interactions Partner cross-functionally with R&D and preclinical teams , including coordination of in vivo studies , to ensure alignment between CMC and biology Drive innovation and continuous improvement , including evaluation of new technologies and COGS reduction strategies for in vivo CAR-T programs Support IP strategy, technical reports, and publications , and present data internally and at external scientific forums Build, mentor, and expand a high-performing team , fostering strong execution, data rigor, and clear communication Requirements: PhD/MS/BS in Chemical Engineering, Biomedical Engineering, Chemistry, Biology, Molecular Biology, or related field 10–15+ years of industry experience in CMC development , including leadership experience 5+ years of experience in nucleic acid and/or lipid nanoparticle (LNP) manufacturing Demonstrated experience advancing programs from preclinical to IND/clinical stages Deep expertise in mRNA manufacturing (IVT, purification, scale-up, characterization) Strong experience with LNP formulation , preferably targeted LNP (tLNP) or conjugation strategies Experience in process development, scale-up, and GMP manufacturing Strong understanding of CQAs, CPPs, and analytical strategies for nucleic acid therapeutics Familiarity with stability, formulation, and product lifecycle management Experience authoring CMC sections for IND/CTA filings and supporting regulatory interactions Experience selecting and managing CDMOs/CROs , including tech transfer and manufacturing oversight Exposure to building or supporting internal manufacturing capabilities Experience with analytical techniques (HPLC/UPLC, FPLC, qPCR, ELISA, LC-MS/MS, MALDI-TOF MS, NMR, cell-based assays, flow cytometry) Familiarity with nucleic acid chemistry, purification, enzyme kinetics , and biomolecule characterization Experience applying Design o