Lead analytical chemistry discovery and development ophthalmology programs, including compound lead screening and selection for topical and implant sustained release dosage forms. Support pre-clinical and clinical development activities, including synthetic chemistry, formulation development, and pharmacology. Manage the development and validation of analytical methods for cGMP testing. Manage method development and analysis of bioanalytical samples for pre-clinical and clinical PK and tissue distribution studies. Manage stability studies for API's and drug products, including the use of accelerated stability predictions (ASAP) for formulation screening and pack selection. Author and review global regulatory submission documents. Manage a team of scientists in Durham, as well as research, development, and GMP work at CRO's within the US.

Advanced new products by leading and delivering analytical project milestones for early and late stage products in US/Europe and Emerging Markets.• Led analytical staff in support of drug product delivery teams for solid drug product dosage forms from first time in human through product launch. Experience with multiple dosage forms including immediate and sustained release tablets and capsules, suspensions, and soft gelatin capsules.• Managed activities related to analytical technical transfer to manufacturing sites worldwide to improve processes and ensure appropriate product testing under GMP conditions. Successfully transferred the first new product into GSK manufacturing site in Tianjin, China. Enabled the site to manufacture and test capsule products by assisting with formulation and analytical transfer in equipment selection, sample preparation techniques, and method validation/transfer.• Developed and validated analytical methods for content, impurities, dissolution, and water content testing for drug products, including new chemical entities, product line extensions, combination products, and products for emerging markets in support of regulatory submissions.• Authored technical documents, including regulatory documents such as INDs, MAAs, and NDAs, method development, validation, and transfer reports, shelf-life justifications, out of specification results, and stability summary reports.• Managed and provided technical support for daily activities of a large analytical team including method development, method validation, stability testing, and formulation support while achieving aggressive project timelines. • Performed analytical testing for drug products including content & impurities, dissolution, CU, and water content in support of formulation development, clinical batch release, and stability studies. Extensive use of HPLC (Atlas & Empower software), UV, and KF titrations.

• Developed and validated analytical methods for pre-clinical and clinical APIs, e.g. stability-indicating assay, impurities, identification, and also for in-process control during synthetic scale-up of APIs and intermediates.• Managed and executed API stability, solubility, and early formulation studies in a GLP environment.• Analyzed high throughput synthesis samples, medicinal chemistry samples, and process chemistry samples using LC-DAD-MS and GC-MS.• Repaired and maintained laboratory instrumentation and equipment.

● Conducted trials to improve processes and reduce manufacturing costs in pulp and paper business unit teams.● Developed solutions to solve quality and product performance problems.