Kernal Bio is seeking a Vice President of Chemistry, Manufacturing & Controls (VP of CMC) with expertise in mRNA-tLNP manufacturing to contribute to the development of its mRNA 2.0 platform for therapeutic applications.
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
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
