Marko Susla Email & Phone Number

Experienced Senior Scientist in the Pharmaceutical Industry. Hands on Method Development, Method Validation, HPLC, LC/MS, LC/MS/MS, Bioanalytical, and Wet Chemistry in a GMP environment – familiar with, ICH, USP/BP/JP requirements. API, drug substance, raw materials, special projects. Quality Assurance and Laboratory Manager as part of the Worldwide Quality & Compliance, Technical Operations Group (Bristol Myers-Squibb). Critical review and data verification for Methods, Technology Transfer, accuracy of Validation Reports, Acceptance Criteria, and raw data review for routine activities. Carried out internal QA audits. Hosted external audits. Authored regulatory documentation and reports.Established GPM LC/MS/MS laboratory expanding current company capabilities and business. Oversight of LC/MS laboratory ensuring overall GPM compliance. FDA audited. No Observations.Lead teams for analytical portion of work supporting a FDA filing of a first in class prescription drug. Lead teams for multiple projects.Author validation protocols (GMP – FDA/ICH), analytical methods, scope of work, final reports, SOP’s, deviations. Raw materials, excipients, drug substance, drug products, impurities, trace level analysis of potent compounds, special projects. Extensive Client interaction evaluating Client needs against capabilities offering solutions to Clients in a GMP environment. Liaison between Clients, Management and Business Development driving the decision making process. Provide input and direction for quoting. Independently carry out Development, Validation, and Client projects at the bench. Provide training to colleagues. Experienced in CRO oversight while working in Large Pharma as well as providing client solutions as a current CRO Senior Staff member. ----------------------Photographer specializing in Fine Art Photography. Exhibited and published.

Listed skills include Hplc, Gmp, Pharmaceutical Industry, Validation, and 39 others.