About
Highly accomplished Analytical Development Scientist with over a decade of experience in the pharmaceutical and biotechnology sectors. Proven expertise in leading and executing hands-on analytical method development, validation, and transfer for diverse therapeutic modalities, including cell therapy and small molecule products. Adept at managing complex CDMO client relationships and overseeing outsourced analytical activities. Combines strong technical leadership with strategic insight, guiding analytical development from early research through clinical trials and regulatory submissions, and is the author of 4 peer-reviewed publications. Consistently drives innovation and ensures compliance.
Work
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Summary
Leads in-house analytical method development and client services, balancing hands-on technical work with CDMO client management.
Highlights
Developed and validated advanced analytical methods for cell therapy characterization, encompassing flow cytometry, PCR-based assays, and cell-based functional tests.
Led a laboratory team in innovating and implementing analytical approaches, effectively resolving complex product characterization challenges.
Managed end-to-end CDMO client onboarding, facilitating seamless technology transfer of analytical methods and defining comprehensive testing requirements.
Designed and implemented robust analytical testing strategies, optimizing workflows for both internal R&D programs and external client products.
Coordinated analytical outsourcing to specialized external vendors, ensuring access to advanced testing capabilities and maintaining project timelines.
Served as a Subject Matter Expert (SME) for analytical method development, qualification, and validation, providing critical technical guidance to internal teams and client sponsors.
Authored and reviewed critical technical documents for regulatory submissions, including Investigational New Drug (IND) filings, as a key technical SME.
Collaborated with Quality Control (QC) and Quality Assurance (QA) to resolve analytical issues, including lot release, stability testing, deviation/OOS investigations, and data trending analysis.
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Summary
Led analytical method development and collaborated on outsourced testing for cell engineering projects.
Highlights
Led the development of analytical methods for cell therapy characterization, utilizing techniques such as flow cytometry, ELISA, and cell-based functional assays.
Provided technical guidance and oversight for outsourced analytical testing conducted by Contract Research Organizations (CROs).
Developed comprehensive specifications for cell therapy products, leveraging deep process understanding and product requirements.
Generated comprehensive analytical data packages critical for regulatory submissions.
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Summary
Developed and implemented analytical methods for clinical research applications, with a focus on cell and gene therapy.
Highlights
Developed and validated analytical methods crucial for assessing cell therapy and gene therapy product quality in clinical research.
Managed external analytical testing with Contract Research Organizations (CROs), overseeing method transfer, validation, and routine testing processes.
Authored comprehensive documentation packages for IND submissions, including detailed method descriptions, validation reports, and specifications.
Collaborated cross-functionally with manufacturing teams to align analytical methods with process development requirements.
Ensured meticulous oversight of trial data, establishing robust archiving and knowledge management protocols.
Skills
Analytical Methods & Instrumentation
Flow Cytometry, ELISA, PCR-based Assays, qPCR, ddPCR, Cell-based Functional Assays, Spectroscopic Methods, Method Development, Optimization, Validation, Troubleshooting.
CMC & Regulatory Affairs
CMC Requirements, IND Filings, Regulatory Submissions, Control Strategies, ICH Guidelines, Analytical Method Validation, Stability Testing, Health Authority Questions.
CDMO Client Management
CDMO Environment, Client Onboarding, Analytical Method Transfer, Outsourcing Management, Technical Liaison, Sponsor Requirements, Project Management, Communication.
Project Management
Strategic Planning, Timeline Development, Resource Allocation, Budget Management.
Technical Leadership
Technical Guidance, Problem Solving, Scientific Direction, Method Troubleshooting, Team Leadership.
Technical Documentation
Technical Reports, Validation Protocols, SOPs, Regulatory Submissions, IND, Phase I/II.
Team Collaboration
Cross-functional Coordination, Stakeholder Communication, Knowledge Sharing, Team Mentorship.
Quality & Compliance
GMP Compliance, GLP Compliance, Analytical Method Validation, OOS Investigation.
Scientific Writing
Peer-Reviewed Publications, Research Dissemination.