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

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 of Experiments (DoE) and bioprocess engineering principles
• Working knowledge of GMP regulations and quality systems
• Strong ability to analyze, interpret, and communicate scientific data clearly
• Excellent written and verbal communication skills
• Strong organization, record-keeping, and data management skills
• High attention to detail with strong problem-solving and troubleshooting ability
• Proven ability to build, lead, and mentor teams in a fast-paced environment
• Experience working in a startup or high-growth environments
• Ability to work independently while collaborating effectively across teams
• Experience with targeted lipid nanoparticles (tLNPs) or ligand/antibody conjugation
• Experience with in vivo studies (e.g., rodent models)
• Prior mammalian cell culture experience
• Experience with automation and high-throughput systems
• Track record of innovation, IP filings, or publications

Benefits

Additional Information

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.

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