Mira Patel Email & Phone Number

New Jersey, United States

New Jersey, United States

• Currently leading CMC technical writing, providing end-to-end (E2E) support, and collaborating with internal teams.• Actively managing regulatory submissions for line extensions, life cycle management, and new submissions.• Authoring and reviewing CMC components for EU and US-FDA compliance in CTD format.• Ensuring ongoing production of high-quality submissions by obtaining information from various departments.• Currently enhancing the development of BLA/IND/IMPD and CMC Life cycle content through meticulous gap identification and strategic edits for precision and compliance.• Representing TDM in cross-functional CMC teams, fostering external collaboration for compliance.• Actively contributing to process improvement, coordinating submissions, and providing mentoring/training.• Attended Next Generation CAR & Cell Therapy Conferences to stay updated on the latest developments in the CGT field

Elevated from subject matter expert to leadership role, mentoring junior engineers and overseeing process changes. Conducted thorough project-level risk assessments, addressing issues with effective solutions. Led strategy-focused meetings within project teams, providing coaching and contributing to cross-functional milestones. Demonstrated proficiency in experimental design, method qualifications, and continuous method improvement efforts. Managed multiple project timelines aligned with business priorities, providing subject matter expert (SME) support for regulatory audits and investigations. Devoted 30% of time to training and supporting regulatory submissions and responses to health authority inquiries. Excelled as an expert in flow cytometer-based assays, operating instruments like flow cytometers, Vi-cell, Multisizer, and qPCR. Developed, optimized, and qualified assays using Quality-based Design (QbD) principles. Conducted risk assessments, evaluated method robustness, repeatability, reproducibility, and variation. Successfully implemented method transfer for immune-therapy drug product NK, including writing developmental stability plans and reports supporting IND. Prepared method validation strategies for PCR and flow cytometry assays based on CAR-T product guidelines. Demonstrated expertise with various biological products (Mesenchymal Stem cells, Natural Killer cells, CAR-T cells). Proficient in method selection, design, and validation for pre-clinical, clinical drug product, and drug substance.

Masters, Molecular Biology

Master Of Science - Ms, Microbiology And Immunology