Vice President, Chemistry, Manufacturing, and Controls (CMC)
About Kernal Biologics, Inc.
Kernal Bio is a venture-backed therapeutics company engineering cells inside the body using AI-designed, selective mRNA and targeted lipid nanoparticle (tLNP) 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 Bristol Myers Squibb. Its leadership team brings a track record that includes three FDA-approved therapies and more than 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) to lead the development and manufacturing of its mRNA 2.0 platform for therapeutic applications. This leader will build, inspire, and guide the team responsible for manufacturing, process development, and analytical development of mRNA-tLNP therapeutics.
The successful candidate will bring deep expertise in mRNA-tLNP chemistry and biology workflows, along with hands-on experience in Good Manufacturing Practice (GMP) manufacturing of mRNA-tLNP products.
Responsibilities
- Lead and scale the CMC organization, defining the strategy for mRNA drug substance and targeted LNP (tLNP) drug product from preclinical through clinical development.
- Oversee the development and scale-up of mRNA in vitro transcription (IVT) manufacturing, purification processes, and tLNP formulation to ensure robust, reproducible performance.
- Build and advance internal and external manufacturing capabilities while strategically selecting and managing contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs) for scale and flexibility.
- Lead design of experiments (DoE)-driven process development, optimization, and technology transfer to support internal and external GMP manufacturing campaigns.
- Establish and manage analytical and bioanalytical strategies—including HPLC, qPCR, ELISA, and cell-based assays—to support product characterization, potency assessment, and release testing.
- Define and execute the CMC regulatory strategy, including authoring IND and CTA sections and supporting interactions with regulatory agencies.
- Partner cross-functionally with research and development and preclinical teams, including coordinating in vivo studies, to align CMC activities with biology and program objectives.
- Drive innovation and continuous improvement, including evaluating new technologies and implementing cost-of-goods (COGS) reduction strategies for in vivo CAR-T programs.
- Support intellectual property strategy, technical reports, and publications, and present data at internal meetings and external scientific forums.
- Build, mentor, and expand a high-performing team that values strong execution, data rigor, and clear communication.
Required Qualifications
- PhD, MS, or BS in chemical engineering, biomedical engineering, chemistry, biology, molecular biology, or a related field.
- 10+ years of industry experience in CMC development, including leadership experience.
- At least five years of experience in nucleic acid and/or lipid nanoparticle manufacturing.
- Demonstrated experience advancing programs from preclinical development through IND submission and clinical-stage development.
- Deep expertise in mRNA manufacturing, including IVT, purification, scale-up, and characterization.
- Strong experience in LNP formulation; targeted LNP or conjugation experience is preferred.
- Experience in process development, scale-up, technology transfer, and GMP manufacturing.
- Strong understanding of critical quality attributes (CQAs), critical process parameters (CPPs), and analytical strategies for nucleic acid therapeutics.
- Familiarity with stability programs, formulation development, and product lifecycle management.
- Experience authoring CMC sections for IND or CTA filings and supporting regulatory interactions.
- Experience selecting and managing CDMOs and CROs, including technology transfer and manufacturing oversight.
- Experience building internal and external manufacturing capabilities.
- Experience with relevant analytical techniques, such as HPLC/UPLC, FPLC, qPCR, ELISA, LC-MS/MS, MALDI-TOF MS, NMR, cell-based assays, and flow cytometry.
- Familiarity with nucleic acid chemistry, purification, enzyme kinetics, and biomolecule characterization.
- Experience applying DoE and bioprocess engineering principles.
- Knowledge of GMP regulations and quality systems.
- Ability to analyze, interpret, and clearly communicate scientific data.
- Excellent written and verbal communication skills.
- Strong organization, record-keeping, and data-management skills.
- High attention to detail, with strong problem-solving and troubleshooting abilities.
- Proven ability to build, lead, and mentor teams in a fast-paced environment.
- Experience working in a startup or high-growth environment.
- Ability to work independently and collaborate effectively across teams.
Preferred Qualifications
- Experience with targeted lipid nanoparticles or ligand/antibody conjugation.
- Experience conducting or supporting in vivo studies, including rodent models.
- Mammalian cell culture experience.
- Experience with automation and high-throughput systems.
- A track record of innovation, intellectual property filings, or scientific publications.
Benefits
- Competitive 401(k) plan.
- Highly competitive healthcare coverage, including PPO and HMO options.
- Free parking, a monthly subway pass, or a subsidized commuter rail pass.
- Free Bluebikes membership.
- Gym membership support.
- Flexible and health Spending account.
- Paid parental, family caregiver, and medical leave.
- Employer-paid life insurance coverage.
- On-site cafeteria.
- Competitive vacation and sick leave.
Equal Employment Opportunity
Kernal Bio is committed to providing a diverse and inclusive work environment and equal employment opportunities to all employees and qualified applicants. We do not discriminate in employment practices based on race, color, national origin, age, sex, gender, sexual orientation, marital or veteran status, religion, disability, or any other status protected by applicable law. Kernal Bio provides reasonable accommodations to qualified individuals with known disabilities in accordance with applicable law.