Lisa Lundberg

About Lisa Lundberg

Over 30 years of extensive experience in immunoassay and bioassay development, optimization, validation, and transfer to internal and external laboratories in government, CRO, and pharmaceutical, biotech and gene therapy industries• In depth knowledge and experience in cGxP/ICH/FDA guidelines and practices • Extensive experience in the translation of immunoassays and cell-based assays from research to the QC laboratory, including feasibility and optimization studies, qualification and transfer to QC laboratory, and validation• Development of new testing procedures, methods and systems, including cell-based assays and ELISA / immunoassay systems for Potency (functional, gene expression, and infectivity) and Characterization, PK and Immunogenicity (ADA/NAb) for GMP release and stability testing • Extensive experience in virus-based assays including the development, optimization, and validation of viral neutralization assays• Extensive oversight and successful collaborations with CROs/CTLs for commercial testing• Significant experience in all aspects of cGxP laboratory management and maintenance, including laboratory audits, documentation review, statistical analysis of results, equipment maintenance and calibration, laboratory testing oversight, and SOP / technical report writing • Strong trouble shooting and problem solving abilities, including “Six Sigma-Green Belt” statistical methodologies• Proven communication, planning and organizational skills, demonstrated by successfully managing multiple clinical trial projects and technical staff

Experience

1. Vice President, Analytical Development and Quality Control

   Vintabio

   Aug 2025 — Present · Philadelphia, PA, US

   Analytical Development• Lead the design, development, and optimization of robust and reliable methods and specifications for in-process controls, material/product release, and stability assessments to support the product development life cycle• Ensure that methods are developed in compliance with regulatory standards and guidelines• Lead phase-appropriate analytical method implementation, qualification, and validation for raw materials, viral vectors, and cell lines• Responsible for experimental/project execution and summary reports• Collaborate with cross-functional teams to support product development• Participate in data mining to enhance analytical and process optimization of VintaProcess™Operational Management• Responsible for ensuring employees are trained on SOP’s, equipment, all unit operations, and systems with a focus on data integrity• Develop and maintain GxP compliant processes, documentation, and systems that are utilized by the team in executing daily responsibilities• Support regulatory submissions both internally and for Clients including INDs and regulatory inspections and auditsQuality Control• Manage QC activities including raw material testing, in-process testing, stability studies, and release testing of products• Ensure QC operations are compliant with cGMP and other applicable regulations• Address and resolve quality issues, deviations, and non-conformances• Oversight of cGMP activities to support manufacturing operations, e.g. gown qualification and environmental monitoringExternal Engagement• Act as primary contact for Client analytical requirements including methods, sampling plans, and stability studies• Align with Client on audit strategy, plan, and execution for analytical and sterility-focused audit activities• Oversee 3rd party testing organizations executing analytical methods including sourcing, qualifying, and managing the labs to support VintaBio process development and production testing needs

Education

• Case Western Reserve University

  BS, Biochemistry

Skills

• Good Laboratory Practice (Glp)
• Drug Discovery
• Protein Chemistry
• V&V
• Clinical Trials
• Elisa
• Laboratory Skills
• Technology Transfer
• Analytical Chemistry
• Quality Control
• Gmp
• Vaccines
• Laboratory
• Bioanalysis
• Method Development
• Standard Operating Procedure (Sop)
• Chromatography
• Cell Biology
• Immunology
• Immunoassays
• Validation
• Glp
• Bioassay
• Sop