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

Kernal Biologics•Boston, MA

About The Position

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.

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

Nice To Haves

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

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