Key leadership roles in Pharmaceutical product development for soft gel capsules. Building product development infrastructure and expertise in new pharmaceutical Softgel ventures.Product, Procedure, Equipment, Facilities, Manufacturing Process & Businesses development leveraging 25 years in Softgel development and leadership roles.

Carried out the design, development and optimization of formulations and processes following ICH Guidelines, including: pre-formulation to clinical manufacturing, scale up and commercial manufacture. • Trained personnel in theoretical and practical aspects of standard and non-standard procedures and developed new formulation approaches in line with project requirements. • Generated and reviewed documents such as experimental plans, product development reports, scale-up protocols and reports, batch record master formulas and other key R&D documents. • Led or participated in relevant project team meetings, providing consultation and leadership to cross-functional teams

Managed product quality and product design at three manufacturing locations, providing guidance and recommendations for process and product quality improvement. • Implemented process and product changes, improving product quality, process efficiency and reducing cost. • Authored master production documentation, product development study protocols, product development reports, product quality reports and productivity reports.• Effectively improved product quality through enhancement of tooling, formulation and in-process quality control.

Formulation of pharmaceuticals, OTC drug products, nutraceuticals, nutritional supplements, recreational and topical products. • Pioneered the Product Development Department at Accucaps Industries, establishing a significant number of standard operating procedures.• Formulated, developed and validated a series of Cough and Cold softgel products leading to expansion of the manufacturing facility to three times the capacity in order to accommodate product demand.• Developed a patented oil in water unit dose delivery system for poorly water soluble drugs.

Led a manufacturing team of up to 10 in a startup soft gel capsule manufacturing facility.Coordinated interdepartmental activities, monitored process activities, reviewed process batch records. Implemented a significant number of process enhancements to improve product quality and process efficiency.