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

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

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/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

Preferred Qualifications

• 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:

• 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.