Ray V.
Senior CMC Regulatory Technical Writer
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Ray V. is a seasoned Technical Writer specializing in the biopharmaceutical and pharmaceutical industries, with over a decade of experience in regulatory technical documentation. His expertise spans global compliance, crafting documents that adhere to ICH guidelines, ISO 9001, and pharmacopeial standards. From 2010 to 2021, he served as a Consultant Technical Writer across organizations like BioMarin Pharma and Puma Biotech, authoring stability protocols and method verification reports while ensuring regulatory alignment through FDA eCTD modules 2 and 3. Previously, Ray worked as a Biological Scientist at Nitto Denko, where he developed and optimized analytical methods and conducted stability studies, contributing to significant advancements in medicinal chemistry. Ray's foundational skills in analytical chemistry, chromatography, method validation, and stability testing are underscored by a strong educational background, including a diploma in Biological Chemical Science and a Bachelor’s degree in Chemical Engineering. He is a certified Professional Chemical Engineer and an active contributor to the American Medical Writer Association. His role involves rigorous data integrity checks and cross-functional collaboration, leveraging his analytical prowess to support both R&D and quality control initiatives.
Experience
Consultant Technical Writer/CMC Regulatory Technical Writer
BioMarin Pharma/Puma Biotech/Treximo/QED Therapeutic/Teva Parenteral Medicines Scientific Affairs/R&D/Analytical Science Services/Irvine Pharma-San Francisco Bay Area, CA · 2010 — 2021Authored Commercial Stability Protocols and Reports, ensuring regulatory compliance for pharmaceutical products. Reviewed and authored Method Transfer/Verification Protocols and Reports to facilitate seamless technology transfer. Assisted with OOS investigations to support root cause analysis and corrective actions. Prepared Laboratory Deviation Reports to document deviations maintaining quality standards. Authored Instrument Qualification Protocols to ensure laboratory equipment met validation requirements. Assembled R&D Chemistry Annual Product Reviews to contribute to continuous improvement initiatives. Responded to internal and regulatory audit inquiries to support successful audit outcomes. Trained and coordinated with CRO, Scientific, and QC personnel on method transfer to enhance collaboration. Reviewed method validation and transfer protocol data from CRO, Scientific Affairs, and QC analytical services, ensuring data integrity.Biological Scientist - Medicinal Chemistry
Nitto Denko and Irvine Pharmaceutical-Irvine, CA · 2009 — 2015Developed and optimized analytical HPLC methods, performing solid support evaluations using DNA and siRNA synthesis platforms. Conducted post-synthesis evaluation and determined the full-length purity of crude oligonucleotides through analytical HPLC. Analyzed and interpreted mass spectrometry results of complex samples while maintaining laboratory instruments through maintenance and calibration. Prepared SOPs, protocols, and in-house documentation. Conducted stability studies on solid support and summarized data for evaluation.Sr. Research Associate
Nanogen Inc.-San Diego, CA · 2003 — 2009Developed chromatographic methods for identity and purity testing of raw materials supporting quality control for oligonucleotides, pRNA's, dNTP, peptides, and antibodies. Validated methods and qualified systems using USP and ICH guidelines to ensure regulatory compliance. Created quantitative test methods for Tris(2-carboxyethyl) phosphine (TCEP) concentration from lyophilized TCEP beads using analytical HPLC. Conducted quantitative and qualitative tests on hybridized and conjugated antibody samples with size exclusion chromatography. Performed stability tests on shelf-life samples and analyzed mass spec results from outsourced laboratories to ensure accuracy. Managed identification and purity tests of oligonucleotide samples through anion exchange and reverse phase HPLC.Chemist - Ab Protein Process and DNA/RNA Oligonucleotide Purification
Quidel Corp./Nanogen Inc. (nee Epoch Bioscience Inc.)-San Diego, CA · 2000 — 2003Conducted purification processes on various hCG antibodies utilizing gel filtration and affinity chromatographic techniques to enhance yield and purity. Improved anti-alpha hCG purification processes and conducted conjugate processes for dipstick and other test kit products supporting development. Monitored quality of processed purified antibodies through Electrophoresis/SDS page and Densitometer. Performed antibody screening using ELISA for performance validation. Managed synthesis of custom oligonucleotides using ABI 3900 and Expedite synthesis instruments.
Skills & Expertise
Education
- Diploma in Biological Chemical ScienceSeneca College of Applied Arts and Technology-Newnham Campus, Borough of North York, Toronto Ontario, Canada · 1992 — 1995
- Bachelor of Science in Chemical EngineeringUniversity of Manila-Manila · 1977 — 1981