Siny Shailendra, MS, MBA

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.

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.

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.