Participate in diverse areas of daily operations, from raw materials procurement to patient retention in clinical trials, providing biotechnology and pharma expertise to clients domestically and internationally. Lead study development and regulatory advising.− Recognized for broad-scope industry expertise and tapped to explain biotech companies’ materials vetting processes to key investors at a hedge fund. Identified materials used (and why), analyzed pricing, examined regulations, and forecasted trends.− Key player in clinical trial development, analyzing relevant factors that lead some trials to have issues with patient retention. Looked at market trends, carried out extensive cost analysis, and delivered recommendations to senior leadership.

Managed clinical trials for major pharmaceutical companies during phase I–III drug development. Scope of leadership responsibility included data management, project management, QA, and logistics, at the same time serving as a primary contact for clients. Established key timelines at the onset of studies and providing ongoing updates and reporting. Effectively trained personnel on protocol-specific requirements, supervised external sites involved in studies, and managed transfer of data to internal databases via QC process and query system. Carried out complex financial management on an ongoing basis, including forecasting and reporting.• Manage clinical trials for major pharmaceutical companies at all phases of drug development (Phase I - III), including data management, project management, QA and logistics. • Main contact with clients for all critical timelines created upon study initiation and lead role in any subsequent organized meeting to discuss and update on set project timelines for duration of study and contract. • Provide training to extra personnel and external sites on protocol specific requirements as well as provide presentations for investigator meetings and upon client need. • Supervise external sites involved in study and all incoming data to internal databases through multiple QC process and query system. • Company equipment and worldwide logistics manager on all study equipment where I perform needed validations (IQ, OQ, PQ) and provide suggestions to company and clients on any equipment upgrade and purchases. • Provide direct input for BD and finance department on all new client budgets and monitor any changes to current budget or change orders if needed to adjust to study changes if needed.

Managed budgets for manufacturing prototypes and biological processing systems, and oversaw procurement processes governing all new biological materials used in R&D. Created document management system for SOPs and Work Instructions. Selected to serve on development team responsible for designing and developing new facility plan for soft-tissue-device production.• Part of development team to design and develop new facility plan for soft tissue device production.• Managed procurement process of all new biological materials used to R&D and eventual product development.• Development of innovative process iterations for the decellularization of biological materials for eventual usage on humans as implants. • Development of SOP and WI for all process and safety procedures to adhere to 21 CFR 820 cGMP and train all technicians on procedures.

Conducted laboratory analysis and oversaw data collection across multiple projects, comprehensively assessing quality and identifying areas for improvement. Researched process iterations to optimize the features of biological gels used in surgeries, and researched and developed improvements on a porcine-xenograft product in order to improve shelf life and lower production costs.• Researched process iterations for creation of biological gels used in surgeries to maximize physical properties and minimize size.• Researched and developed improvements on company iterations of porcine xenograft product to improve previous shelf life and reduction of production costs. • Worked using stage-gate product innovation process to improve on compact products and create new products for eventual scale up and market implementation. • Conducted laboratory analysis and data collection on all projects and assessed quality of final products and voiced improvement measures when needed.