Liam Kapilow-Cohen

About Liam Kapilow-Cohen

Strategic CMC & Quality Leader | Advancing Pharmaceutical DevelopmentAccomplished CMC, Quality Control, and Quality Operations Senior Manager with 17+ years of experience in cGMP/GLP pharmaceutical development and manufacturing, spanning cell and gene therapy, small and large molecules. Dedicated to improving patient outcomes by ensuring high-quality, compliant, and efficient pharmaceutical processes.Expertise in: Process Excellence & QMS: Architecting risk-based quality management systems (QMS), ensuring compliance, and driving continuous improvement. Certified Six Sigma Green Belt with expertise in FMEA, CAPA, RCA, and KPI tracking. Analytical Method Development & Validation: Specialized in developing, qualifying, validating, and transferring bioassays, potency, content, and purity methods using cell-based (flow cytometry), chromatography (HPLC/UPLC), ligand binding (ELISA/MSD), and qPCR/ddPCR platforms. Quality Control & Manufacturing: Extensive experience in sterile DP manufacturing, aseptic processing, QC analytical testing, batch record review, supplier quality management, sample and critical reagent management, and regulatory compliance. SME & Person-in-Plant for complex QC and manufacturing operations. Regulatory & Compliance Leadership: Deep knowledge of cGMP, GLP, ICH, USP, and GDP. Lead author of IND, NDA, BLA, and MAA submissions. Successfully managed FDA inspections (three with zero findings) and led aseptic processing/warning letter remediation. LIMS & Data Systems: Spearheaded LIMS/ELN implementation, statistical modeling (JMP), process validation, CPV, shelf-life prediction, and digital quality management tools (Trackwise, Veeva, BMR). Cross-Functional Leadership: Proven ability to align supply chain, manufacturing, MSAT, quality, and regulatory teams, ensuring seamless collaboration with external CMO/CDMOs, CTLs, and regulatory agencies. Project & Stakeholder Management: Strong program leadership in fast-paced environments, standardizing communication and ensuring alignment. Leadership & Mentorship: Committed to developing talent, fostering high-performing teams, and driving operational excellence.Focused on ensuring compliance with global regulatory standards while delivering high-quality, timely results to accelerate pharmaceutical innovation.

Experience

1. Associate Director, Quality Control

   Celldex

   Apr 2025 — Present

Education

• Virginia Tech

  BS, Biochemistry

Skills

• Cmc Development
• Vaccines
• U.s. Food and Drug Administration (Fda)
• CRO
• CRO Management
• Standard Operating Procedure (Sop)
• Antibodies
• Analytical Method Validation
• High-Performance Liquid Chromatography (Hplc)
• Quality Control
• Small Molecules
• Gmp
• Assay Development
• Fda Gmp
• Risk Management
• Management
• Pharmaceutical Industry
• Fda
• Biotechnology
• Oligonucleotides
• Hplc
• Glps
• Spectroscopy
• Analytical Methods Development
• Analytical Chemistry
• Drug Development
• Biopharmaceuticals
• Ind
• Validation
• Mass Spectrometry
• Process Improvement
• Pharmaceutics
• Glp
• Good Laboratory Practice (Glp)
• Formulation