Carlton Phi

Background

About Carlton Phi

Pharmaceutical Industry professional with experience in R&D, Quality, and Supply Chain Support. Diverse quality background with experience from supporting R&D stability of finished products for NDAs, formulations and process development for clinical trials, and QC Raw Materials for Supply Chain. QC Projects include global technical method transfers. Configuration, validation, and technical method transfer of NIR equipment and ID method including software configuration and CSV to meet cGMP Data Integrity compliance. Using quality risk management principles, performed evaluation, and generation of supporting documents for reduced testing programs for raw materials. Experienced at supporting LEAN lab operations from generating, reviewing, and performing lab release of GMP data to support sample and product release for registration and commercial manufacturing. Proficient with use of electronic quality management systems to document laboratory investigations, planned deviations, discrepancies, supplier issues, and CAPAs. Technical writing experience producing protocols, SOPs, investigations, and reports to support: IND/NDA registration, R&D technical reviews, and supply chain operations. Excelled at complex chromatography assays for API, finished products, leachables, extractables, and developing controlled release methods for formulation studies. Trained and mentored of new hires and post doctorates in analytical assays, formulation development equipment, cGMP and other lab technology. R&D stability experience with a variety of dosage forms including ophthalmic solutions/suspensions, gels, creams, tablets, soft gel capsules, liquids and bio-degradable implants. R&D formulation and process development experience for drug delivery of small molecule APIs using controlled release biodegradable implant technology. Project support included the formulation development of 3-12MO release formulations, process development using Quality by Design approaches for clinical manufacture. Also performed method development of in-vitro drug release method (real time and accelerated), and management of testing by analytical group. Specialties: Formulation Development, Process Development, HPLC, GC, NIR, Stability, Technical Report Writing, Raw Materials, Direct Materials, Technical Transfer, SOP, GMP, Data and Integrity, Extrusion, Extractables, LIMS, microCT, Minitab, JMP Statistical Software, Lean Six Sigma, Trackwise, Validation, Investigations, CSV.