Andrea Bertolotti-Ciarlet
Vice President - Head of Vaccine Bioanalytical Development @Takeda
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WORK HISTORY
Vice President - Head of Vaccine Bioanalytical Development @Takeda
Lead the newly formed Vaccine Bioanalytical Development organization, encompassing Serology, Clinical Assay Development, Analytical Development, Analytical Services, Critical Reagents, and Research in support of Takeda’s vaccine portfolio. o Provide strategic and operational leadership for all bioanalytical activities supporting regulatory filings, post approval commitments, and life cycle management of the QDenga dengue vaccine. o Oversee bioanalytical strategy and execution for regulatory commitments and life cycle management of the QDenga dengue vaccine, ensuring continued global supply and compliance. o Own the long-term roadmap for quality control assay modernization, including selection and deployment of robotics and automation platforms, and incorporation of advanced data analytics and machine learning to enhance assay robustness and throughput. o Partner cross-functionally with Manufacturing Sciences and Technologies, Drug Substance and Drug Product Development, Regulatory Affairs, Quality, and Clinical teams to align priorities and integrate bioanalytical strategies across the vaccine value chain. o Coordinate end-to-end implementation of new assays with Regulatory Affairs, Supply Chain, and Quality Control to de-risk technology transfer and maintain uninterrupted commercial vaccine supply. o Ensure robust support for ongoing clinical and surveillance studies through disciplined sample management, risk‑based laboratory auditing, and proactive clinical assay readiness to meet regulatory and GCP expectations. o Identify, structure, and govern strategic external collaborations to access cutting-edge technologies and maintain state-of-the-art scientific capabilities. o Provide program inputs to annual budget and MRP processes, ensuring all internal and external activities are appropriately scoped, resourced, and financially managed. o Lead and develop a high-performing team of 50+ scientists and researchers.
EDUCATION
Universidad de los Andes (VE)
Bachelor's degree, Biology, General
Baylor College of Medicine
Ph.D., Molecular Virology
Instituto Venezolano de Investigaciones Científicas
Master's degree, Microbiology and Immunology
SKILLS
ABOUT ANDREA BERTOLOTTI-CIARLET
Research, Drug Discovery, and Development Professional25+ years of expertise spanning research, drug discovery, and biopharmaceutical development. Proven leader in driving innovation, operational excellence, and cross-functional collaboration. Key highlights include:Scientific Expertise• In-depth knowledge of cell and molecular biology, with specialized expertise in virology and microbiology.• Skilled in biochemical and cell-based assay development for both small and large molecules, enabling target discovery, lead identification, and optimization.• Extensive experience in method development, transfer, and validation for small molecules, vaccines, and biologics manufacturing.• Strong understanding of GLP/GMP guidelines and regulatory submission processes for clinical and preclinical drug development.Industry Acumen• Comprehensive knowledge of biopharmaceutical operations, including biologics drug development, lifecycle management, and regulatory submissions.Leadership & Team Building• Demonstrated success in hiring, mentoring, and managing high-performing scientific teams.• Adaptive leadership style to align with shifting programs, portfolios, and business objectives.• Proven ability to lead cross-functional teams and deliver business-critical results.Innovation & Collaboration• Track record of developing and implementing innovative assay strategies to support project and portfolio goals.• Skilled collaborator with internal and external stakeholders, excelling in matrixed team environments.• Highly effective in fostering enthusiasm, operational rigor, and scientific excellence across teams.Communication & Facilitation• Adept facilitator with the ability to engage comfortably at all organizational levels, energizing and driving alignment across diverse groups.
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