SPDS ERP Review-May 2015

LITON ROY PhD

490 Woodbine Way 417 Palm Beach Gardens, FL 33418

linkedin.com/in/litonroy Ph: 802-324-2363 Fax: 561-847-2312

litonroy@live.com

Summary Highly motivated scientist with over 12 years of combined experience in pharmaceutical industry and academia; encompassing discovery through development. Experienced leader in team building, motivation, and developing staff to deliver results. Demonstrated ability to work effectively in cross- functional and global roles with experience in managing multiple priorities and strategic analytical development. Professional Experience Sancilio and Company, Riviera Beach, FL (Manager of Laboratory Operations), December 2013- present • Overseeing multiple early and late phase small molecule drug product development projects. • Managed multiple direct reports, stability program, quality systems, and external audits. • Led analytical development for FDA approval of generic Prometrium for treatment of secondary amenorrhea, generic Lovaza and Vascepa to help lower triglycerides, and generic Amitiza to treat chronic idiopathic constipation in adults. • Led research program for Estradiol vaginal capsules for treatment of postmenopausal women for vulvar atrophy. • Developed testosterone enanthate and tadalafil combination therapy for sever and intermediate testosterone deficiency using advanced lipid technology. • Led microbiology quality control, qualification, and validation. • Hired and developed staff to support exceptional growth of the corporation. Sancilio and Company, Riviera Beach, FL (Group Leader/Senior Scientist), December 2012- December 2013 • Led a research group to develop, qualify, and validate various analytical methods for successful submission of 2 INDs and 1 ANDA in one fiscal year. • Led cleaning validation program. Coordinated validation strategies, activities, training, and execution plans with all associated departments. • Developed, validated and implemented HPLC and GC based cleaning verification methodologies. • Designed qualitative and quantitative FTIR methods for finished dosage and raw material testing. • Supervised analytical laboratory internship program. • Overhauled equipment qualification program and implemented advanced protocols for analytical operations. • Collaborated with QA in developing new SOPs and work instructions. Perrigo, Georgia, VT (Associate Scientist, Global Scientific Affairs), August 2011- November 2012 • Set up a new analytical research and development laboratory. Managed proper installations, qualifications, and documentations of new instruments. Implemented new standard operating procedures and work instructions. Established and maintained GMP compliance. • Reported to VP of R&D. Led and managed network-wide quality related projects. Provided analytical data and scientific justifications for business decisions. • Developed and validated stability indicating HPLC methods and chiral LC methods for small molecule drug products in cGMP environment.