SPDS ERP Review-May 2015

81 / 122

LITON ROY PhD
490 Woodbine Way 417
Palm Beach Gardens, FL 33418 Ph: 802-324-2363
Fax: 561-847-2312
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.