Agnieszka Lewandowska
Associate Director Analytical Development @Immunocore
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WORK HISTORY
Associate Director Analytical Development @Immunocore
Deliverables & ImpactLed CMC bioassay development and testing initiatives at Immunocore, establishing high standards for cellular potency and plate-based activity methods. Spearheaded a high-performing Bioassay Team through the full lifecycle of method development, qualification, and validation—from early-stage research through GMP manufacturing scale-up and global regulatory approval.Key Responsibilities & Achievements• Directed the development and qualification of advanced bioassays, ensuring precision and robustness through rigorous AQbD/DoE methodologies.• Oversaw technical transfer to external GMP manufacturers and maintained strict compliance oversight across CDMOs for cGMP, Quality, and contractual standards.• Authored and contributed critical analytical data packages to regulatory submissions, ensuring scientific integrity and full compliance from Phase 1 through to BLA/MAA approvals.• Championed strong collaboration and influencing skills in matrix environments, serving as a key R&D Program liaison and influencer to bridge Research, Development and Technology leadership.• Fostered cross-departmental synergy and drove operational excellence by implementing analytical efficiencies and maintaining a cutting-edge awareness of the patent and competitor landscape.
EDUCATION
Universidad de Salamanca
Molecular Biology
Uniwersytet Technologiczno-Przyrodniczy im. Jana i Jędrzeja Śniadeckich w Bydgoszczy
MSc Eng, Biotechnology
ABOUT AGNIESZKA LEWANDOWSKA
Dynamic Analytical CMC Leader driving the strategic development of innovative protein therapeutics, multispecifics and immune cell engagers from concept to commercial readiness. I specialize in building robust analytical control strategies that ensure the safety, efficacy, and quality of complex therapeutic modalities and ATMPs.Throughout my career, I have successfully progressed over 20 drug candidates, enabled the on-time clinical availability of 3 products, and authored key analytical sections for 5 regulatory submissions (IND, IMPD, BLA). I thrive in lean, fast-paced environments where scientific rigor must be balanced with pragmatic execution and speed.Core Expertise:• Analytical Strategy: Defining phase-appropriate control strategies, specifications, and comparability justifications.• Method Lifecycle: Expert in method qualification/validation (ICH Q14, ICH Q2 (R2)) and pioneering AQbD (USP;) adoption.• External Governance: Vendor selection and strategic oversight of global CDMOs/CROs, ensuring inspection readiness and technical excellence. Active member of the BioPhorum Development Group workstream, collaborating with industry peers to shape best practices in biopharmaceutical development.• Leadership: Building and coaching healthy high-performing, diverse scientific teams in matrix environments.I am passionate about optimizing the path from bench to clinic, ensuring that every analytical decision is risk-based, clinically relevant, and regulator-ready. I actively contribute to implementation of the AI CMC engine in collaboration with stakeholders internal or external to IMCR to maximize value of data from the automated workflows.Contact email a••••••••@gmail.com
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