Kernalbio

Kernalbio

Vice President, Chemistry, Manufacturing & Controls (CMC) – mRNA-tLNP Therapeutics

Boston, MA · Exec

Sponsorship not specifiedDetected 1 day ago
Product ManagementIntellectual PropertyGMPFDA RegulatoryqPCRMolecular BiologyCell CultureResearchMass SpectrometryProtein AnalysisAnimal StudiesLeadershipCommunicationProblem SolvingGxP

About the role

  • 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.
  • 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.
  • 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.

Requirements

  • 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.
  • 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 with relevant analytical techniques, such as HPLC/UPLC, FPLC, qPCR, ELISA, LC-MS/MS, MALDI-TOF MS, NMR, cell-based assays, and flow cytometry.

Nice to have

  • 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.
  • targeted LNP or conjugation experience is preferred.
  • Strong experience in LNP formulation

Benefits

  • Highly competitive healthcare coverage, including PPO and HMO options.
  • Free parking, a monthly subway pass, or a subsidized commuter rail pass.
  • Gym membership support.
  • Flexible and health Spending account.
  • Paid parental, family caregiver, and medical leave.
  • Employer-paid life insurance coverage.
  • Competitive vacation and sick leave.

Equal 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.
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This listing is sourced directly from Kernalbio's careers page and normalized into a canonical job model.