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

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:


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Lead and scale the   CMC organization , defining strategy for mRNA drug substance and targeted LNP (tLNP) drug product from preclinical through clinical development


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Oversee development and scale-up of   mRNA IVT manufacturing , purification processes, and   tLNP formulation , ensuring robust, reproducible performance


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Build and drive   internal manufacturing capabilities , while strategically leveraging and managing   CDMOs/CROs for scale and flexibility


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Drive   process development (DOE-driven) , optimization, and tech transfer to support   GMP manufacturing campaigns   (internal and external)


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Establish and manage   analytical and bioanalytical strategies   (e.g., HPLC, qPCR, ELISA, cell-based assays) to support product characterization, potency, and release


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Define and execute   CMC regulatory strategy , including authoring IND/CTA sections and supporting agency interactions


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Partner cross-functionally with   R&D and preclinical teams , including coordination of   in vivo studies , to ensure alignment between CMC and biology


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Drive   innovation and continuous improvement , including evaluation of new technologies and   COGS reduction strategies   for in vivo CAR-T programs


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Support   IP strategy, technical reports, and publications , and present data internally and at external scientific forums


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Build, mentor, and expand a   high-performing team , fostering strong execution, data rigor, and clear communication


Requirements:


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PhD/MS/BS in Chemical Engineering, Biomedical Engineering, Chemistry, Biology, Molecular Biology, or related field


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10–15+ years of industry experience in   CMC development , including leadership experience


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5+ years of experience in   nucleic acid and/or lipid nanoparticle (LNP) manufacturing


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Demonstrated experience advancing programs from   preclinical to IND/clinical stages


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Deep expertise in   mRNA manufacturing   (IVT, purification, scale-up, characterization)


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Strong experience with   LNP formulation , preferably   targeted LNP (tLNP)   or conjugation strategies


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Experience in   process development, scale-up, and GMP manufacturing


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Strong understanding of   CQAs, CPPs, and analytical strategies   for nucleic acid therapeutics


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Familiarity with   stability, formulation, and product lifecycle management


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Experience authoring   CMC sections for IND/CTA filings   and supporting regulatory interactions


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Experience selecting and managing   CDMOs/CROs , including tech transfer and manufacturing oversight


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Exposure to building or supporting   internal manufacturing capabilities


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Experience with   analytical techniques   (HPLC/UPLC, FPLC, qPCR, ELISA, LC-MS/MS, MALDI-TOF MS, NMR, cell-based assays, flow cytometry)


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Familiarity with   nucleic acid chemistry, purification, enzyme kinetics , and biomolecule characterization


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Experience applying   Design of Experiments (DoE)   and bioprocess engineering principles


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Working knowledge of   GMP regulations   and quality systems


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Strong ability to   analyze, interpret, and communicate scientific data   clearly


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Excellent   written and verbal communication skills


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Strong   organization, record-keeping, and data management skills


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High attention to detail with strong   problem-solving and troubleshooting ability


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Proven ability to   build, lead, and mentor teams   in a fast-paced environment


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Experience working in a  startup or high-growth environments


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Ability to work independently while collaborating effectively across teams


Preferred Qualifications


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Experience with   targeted lipid nanoparticles (tLNPs)   or ligand/antibody conjugation


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Experience with   in vivo studies (e.g., rodent models)


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Prior   mammalian cell culture experience


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Experience with   automation and high-throughput systems


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Track record of   innovation, IP filings, or publications


Benefits :


• Competitive 401(k)   

• Highly competitive healthcare coverage (PPO/HMO)

• Free parking, a monthly subway pass, or a subsidized commuter rail pass  

• Free Bluebike Membership

• Gym Membership Support   

• Flexible Spending Account 

• Paid parental leave, family caregiver leave, and medical leave  

• Paid life insurance coverage 

• On-site cafeteria  

• Competitive vacation and sick days per year 

Kernal provides a diverse work environment and is committed to equal employment opportunities for all its employees and qualified applicants. We do not discriminate in employment practices for the race, color, national origin, age, gender, sexual orientation, marital or veteran status, religion, disability, or any other legally protected status. Kernal Bio will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.