Sam Mathew, Ph.D Email & Phone Number

Over 25 years of experience in analytical development, in both small molecules and biologics. Hands-on experience with several successful regulatory filings including solid oral dosage products as well as protein therapeutic drugs. Strong project management skills, verbal and written communication, interpersonal and computer skills.Strong technical background in biologics development:• People management experience with a diverse group of direct reports with a mixture of B.S., M.S., and Ph.D degrees.• Lead analytical development subteams and interact extensively with multidisciplinary and multi-site groups including external vendors and/or strategic suppliers. • Core member of the CMC development team with key interactions with API and Drug Product team leaders, Supply Chain technical groups, regulatory and quality organizations, and external partners.• Hands-on experience in the development, qualification, validation, and technology transfer of methods for biologics for the intended use of drug substance and drug product in-process, release, and stability testing, extended characterization, and process and formulation development support.• Experience with the development and validation of analytical methodologies, management and justification of product specifications, qualification of reference materials, planning and execution of comparability studies, and management of GMP laboratories.Regulatory and quality experience:• Support major and/or minor filings for new products and author amendments, annual reports, agency responses, and other submissions.• Functional assay inception, design, optimization, qualification, and validation to GMP standards.• Authored development, qualification, validation, and technology transfer protocols and reports.• Knowledge of regulatory guidelines (FDA, EMA, USP, ICH).• Authored quality investigations, CAPAs, and change controls.

Listed skills include Validation, Technology Transfer, Gmp, Pharmaceutical Industry, and 46 others.