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/CROsfor 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 evaluat