Donovan Spence

Background

About Donovan Spence

PROFESSIONAL SUMMARY Entrepreneur Discovers Science Successful small business start-up professional uses (19) years of leadership and project management experience to pursue a passion in science. Progressive responsibility over the past fifteen (15) years from entry-level operator to senior process technician positions within commercial technical operations producing plasma protein therapeutics for the pharmaceutical/biotech industry. Transitioned to scientist role for late-phase small-molecule vaccine purification process development from Phase I to Phase CTM. Evolved to the facility licensing and process validation of a bulk live-viral-vaccines for a major manufacturer in the RTP area. Currently engaged as a people manager concentrating on Safety, Compliance, Supply, Strategy, and Profit Plan. CORE COMPETENCIES * Ability to manage activities in terms of costs, methods, schedules, and employees.* Select, hire, train, evaluate performance and motivate staff.* Knowledge of GMPs, industry regulations, hazardous material handling.* Create, revise, and review SOPs, batch records, associated documents, and spreadsheets.* Experience in electronic systems (Delta-V, SAP, LIMS, ABB, Unicorn, and Microsoft Office).* Accomplished in trouble shooting equipment problems and collaborating with maintenance to remedy corrective actions.* Aseptic techniques associated with sampling, laboratory, filling, and gowning.* Techniques associated with column packing and method testing for chromatography skids. Specialties: Process development, documentation, downstream protein purification, file management, gmp, inventory management, loss prevention, microsoft office, process engineering, technical reports, safety, SAP, scheduling, supervisory skills, technical support, troubleshooting, upstream plasma fractionation, supervisor/ manager, finacial management, contract negotiation, bidding, estimating, purchasing