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

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.

Requirements

• 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.