Vidhya M. Email & Phone Number

United States

Serve as single point of contact for Regulatory-CMC for authoring and coordinating updates for clinical and commercial filings (IND, IMPD, BLA, MAA). Represent Quality Control at cross-functional CMC and Commercial meetings to support prioritization, timelines, communicate issues between teams. Author analytical reports and sampling plans and review specifications, specification justification reports, process validation master plans, and process justification reports.

Oversaw method development, validation, and transfers for preclinical and Phase III small molecule drug substance and drug product programs at CDMOs ensuring high quality and consistent timely completion. Reviewed and approved method validation and verification protocols, raw data, reports, and analytical methods. Generated, reviewed, and approved deviations, change controls, SOPs, and CAPAs. Authored analytical sections for regulatory submissions to FDA, MHRA, and EMA. Managed two direct reports within analytical development team.

Led cross-functional CMC development team for preclinical asset - ran meetings, generated meeting minutes, and maintained action items. Coordinated with clinical, preclinical, and regulatory functions in interdepartmental drug development team to build integrated development plan and build project timelines. Managed method development and validation for preclinical and Phase III drug substance and drug product programs at CDMOs.

Supported analytical method development and validation for drug substance, drug product, and in process control methods at CDMOs. Reviewed raw data, analytical methods, and reports generated at CDMOs. Supported CMC team with authoring of regulatory submissions.

Developed and validated HPLC and GC assays for testing intermediates, API, and in process controls to support development, manufacture, and release testing. Authored validation protocols, validation reports and methods. Reviewed raw data, methods, and technical reports from peers and CMOs. Coordinated stability studies for drug substance and drug product programs. Trained analysts in the use of Empower and HPLC.

Developed and validated HPLC and GC assays for API and intermediate release testing. Authored validation protocols, validation reports and methods. Reviewed raw data, methods, and technical reports from peers and CMOs. Analyzed data and presented updates at technical team meetings.

Analyzed samples for development, stability, and clinical release. Collaborated with chemical and process development groups to support API process development optimization. Supported method transfer and verification at CMOs and CROs with protocols, reports and data review.

Canton, Ma

Analyzed OTCs, multivitamins, and stability samples in a GMP laboratory working with primarily HPLC and UV-Vis spectroscopy. Conducted dissolution testing to ensure effective drug release. Performed regular calibration of UV/Vis spectrometer and dissolution instruments and assisted in the training of newer chemists.

Canton, Ma

Tested raw materials, food, and OTC drug samples in a GMP laboratory using AOAC, USP, and FCC methods as well as in-house SOPs. Routinely carried out assays using techniques including Liquid-Liquid Extraction, UV/Vis Spectroscopy, IR Spectroscopy, and TLC and generated reports. Coordinated with group members and client services managers to efficiently complete testing and meet client deadlines.

As part of a collaboration between Boston University's Chemistry and Biomedical Engineering Departments, synthesized nanoparticles, ran columns, and generated UV/Vis spectra. Analyzed nanoparticle stability using dynamic light scattering and zeta potential. Worked with established procedures and developed new protocols.

Prepared chemicals for and oversaw the biochemistry lab in the absence of supervisor. Took inventory of materials in lab, requested required instruments, and closed up the lab at night.

Formulated and prepared chemistry demonstrations to illustrate concepts to students for advanced introductory chemistry course.

Master Of Science - Ms, Pharmaceutical Sciences

B.A., Chemistry

Activities and Societies: Kung Fu Club-Graduated with Distinction in Chemistry -Undergraduate Thesis Project: "Stability of Hydrophilic.

Education record

Activities and Societies: National Honor Society