United States
I'm an experienced CMC Data Reviewer with a background in quality systems, documentation review, and regulatory compliance across leading biotech and pharmaceutical companies. My work has supported FDA, IND, BLA, and MAA submissions by ensuring data integrity, accuracy, and adherence to GMP, ICH, and 21 CFR Part 11 standards. At GSK, I review analytical datasets in Veeva and SLIM, collaborating closely with QA and regulatory teams to support submission readiness. My previous roles at Vertex, Siemens Healthineers, and Takeda gave me hands-on experience in deviation documentation, CAPA support, and analytical testing using tools like HPLC, IR, and UV-Vis. Currently pursuing a Master’s in Regulatory Affairs, I’m actively expanding my expertise and aiming to transition into a formal Regulatory Affairs role. I'm passionate about ensuring documentation accuracy, compliance, and helping bring safe and effective therapies to patients. Let’s connect! I’m always open to building relationships with professionals in quality, CMC, and regulatory development.
Supported CMC regulatory submissions (IND, BLA, MAA) by ensuring analytical data completeness, accuracy, and traceability for Module 3 content. • Reviewed and reconciled analytical datasets (HPLC, GC, KF, IR, XRPD, PSD) to ensure alignment between raw data, reports, and regulatory source documents. • Partnered with Regulatory Affairs, QA, QC, and external CMOs to resolve submission-critical discrepancies under accelerated timelines. • Ensured CMC data packages met FDA, EMA, and ICH expectations, contributing to inspection-ready submissions. • Supported submission readiness using Veeva Vault, SLIM, QDM, Spotfire, and DTT, ensuring document version control and audit traceability. • Assisted in maintaining compliance with 21 CFR Parts 210/211 and 11, supporting global regulatory filing requirements. • Contributed to cross-functional planning to meet key regulatory milestones for high-priority development programs. • Supported preparation and internal review of CMC documentation packages prior to regulatory submission.
Authored and investigated deviation reports, CAPAs, and change controls using QMS tools (e.g., Veeva) Ensured data and process alignment with FDA regulatory expectations, supporting commercial product lifecycle activities
Performed analytical testing using HPLC, UV-Vis, and IR instruments for raw materials and finished products Generated and reviewed lab data logs to ensure compliance with GMP protocols and lab data integrity standards Maintained accurate calibration logs and inventory of reagents, contributing to operational efficiency Supported root cause analysis (RCA) investigations for out-of-spec results
Operated equipment in a cleanroom environment to support upstream/downstream biopharmaceutical manufacturing Followed batch records and SOPs for sterile operations, ensuring product quality and compliance with GMP regulations Assisted with troubleshooting equipment during production runs to minimize downtime and maintain schedule adherence Participated in daily shift meetings to report deviations, trends, and continuous improvement opportunities