Vice President of Chemistry Manufacturing and Controls ...

Vice President of Chemistry Manufacturing and Controls (VP of CMC)VP of CMCAbout 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.Job Summary:Kernal Bio is seeking a highly motivated and experienced Vice President of Chemistry Manufacturing and Controls (VP of CMC) or Director of Process Development with expertise in mRNA 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 the manufacturing, process development, and analytical development of mRNA LNP therapeutics. Proficiency in mRNA LNP chemistry and biology workflows, coupled with experience in Good Manufacturing Practices (GMP) mRNA LNP manufacturing, is essential for this role.Responsibilities:Lead the CMC team and guide the company’s drug substance and drug product manufacturing strategyWork with senior management to expand the company’s CMC teamStay up-to-date on pertinent literature and prepare technical reports and white papers for internal useOversee the synthesis and purification routine mRNA LNP products for preclinical studiesEstablish and optimize the company’s mRNA IVT manufacturing scale-up capabilityCarry out process development studies using the design-of-experiments (DOE) approachOversee routine analytical and bioanalytical tasks such as HPLC, qPCR, ELISA, fragment analysis, cell-based assays, fluorescence, and flow cytometryCoordinate in vivo studies in rodents for quality validationCollaborate with the R&D teams and support experiments on Kernal Bio’s R&D pipelineAssist in I.P. filings and manuscript preparationsSelect and manage CROs and CDMOs (with some travel if/when needed)Oversee GMP manufacturing campaignsCollaborate with academic partners for external preclinical studiesPrepare CMC sections for regulatory filingsOversee COGS reduction strategy for in vivo CAR-T productPresent scientific findings internally and externally at critical scientific conferences and industry eventsAnalyze, summarize, and present experimental results to team members and managementContribute to technical discussions and intellectual property related to the development and application of Kernal’s proprietary technologiesExplore new technologies and methods to optimize current processes in a fast-paced research environmentMaintain up-to-date records and communicate results to team members in written technical reports and oral presentationsParticipate in experimental design and troubleshooting effortsInterpret, summarize experimental data and maintain excellent laboratory notebooksRequirements:PhD/MS/BS in Chemical Engineering, Biomedical Engineering, Chemistry, Biology, Molecular Biology, or a similar field10 years of industry experience in CMC field with 5 years of academic or industry experience in nucleic acid and/or lipid nanoparticle manufacturingAttention to detail, ability to multi-task, and trouble-shootStrong written and verbal communication skillsExcellent record keeping and data management skillsThe ideal candidate is adaptable, enthusiastic about new challenges, has an innate curiosity, and a passion for learningExperience working in fast-paced startup environmentsExcellent organization skills, approaching tasks with efficiencyAbility to analyze, summarize, and communicate scientific dataAbility to work independently while effectively interacting and collaborating in a team environmentPreferred: Experience with targeted lipid nanoparticlesPreferred: Experience with automationPreferred: Prior mammalian cell culture experiencePreferred: Familiarity with nucleic acid purification and chemistry, enzyme kinetics, and analytical characterization of biomoleculesPreferred: Experience with analytical techniques HPLC/UPLC, FPLC, MALDI-TOF MS, LC-MS/MS, NMRPreferred: Experience with bioprocess engineering principles, process modeling, and Design of Experiment (DoE) statistical tools and GMP regulationsNice to have: Prior in vivo experience with miceCompetitive 401(k)Highly competitive healthcare coverage (PPO/HMO)Free parking, a monthly subway pass, or a subsidized commuter rail passFree Bluebike MembershipFlexible Spending AccountPaid parental leave, family caregiver leave, and medical leavePaid life insurance coverageOn-site cafeteriaCompetitive vacation and sick days per yearKernal 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. #J-18808-Ljbffr

Created: 2025-09-25