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.
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 evaluation of new technologies and COGS reduction strategiesfor 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 innucleic 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 inprocess development, scale-up, and GMP manufacturing
Strong understanding of CQAs, CPPs, and analytical strategiesfor nucleic acid therapeutics
Familiarity withstability, formulation, and product lifecycle management
Experience authoring CMC sections for IND/CTA filingsand 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 withnucleic acid chemistry, purification, enzyme kinetics, and biomolecule characterization
Experience applying Design of Experiments (DoE)and bioprocess engineering principles
Working knowledge of GMP regulationsand quality systems
Strong ability toanalyze, interpret, and communicate scientific dataclearly
Excellentwritten and verbal communication skills
Strongorganization, record-keeping, and data management skills
High attention to detail with strongproblem-solving and troubleshooting ability
Proven ability to build, lead, and mentor teamsin 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 within vivo studies (e.g., rodent models)
Priormammalian cell culture experience
Experience withautomation and high-throughput systems
Track record ofinnovation, IP filings, or publications
Benefits
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.
