Motivated people-oriented team leader successful in monitoring performance, delegating work and motivating members. Versed in managing daily direction and team communication. Collaborative and resourceful professional dedicated to identifying needs to develop and deliver creative solutions.
Cell Culture: primary and immortalized cell and tissue culture: mammalian, insect and plant cell. Transfection, transformation and cell-based assay development. Drug screening assays, cytokine and mRNA analysis by Luminex and Quantigene (bDNA) technologies., Protein sciences: expression and purification, denaturation and refolding of proteins from nearly all biologic sources. In vitro assay development (EIA, ELISA under GLP). Chromatography and electrophoresis., Biophysics: characterization (DSC, DLS, AUC, CD and calorimetric analyses); protein stability and folding, binding affinity, enzyme kinetics. FPLC and HPLC: affinity and differential chromatography., Formulation sciences: protein, peptide hormone and small molecule API formulation technology and optimization. Nasal delivery technology/discovery and development for protein and peptides. Assay development (cell-based and in vitro) for efficacy, stability and permeation enhancement and safety (cytotoxicity/immunogenicity). RNAi delivery and knockdown assay development with nanoparticle biophysical characterization and optimization (stability, safety and efficacy). Technology transfer, scale-up and process development., Clinical and pre-clinical drug manufacture under cGMP; Method development and validation, Quality Control. Regulated data systems (LIMS), formulations and medical device technology and QC testing (nasal spray actuators and vascular drug-delivery catheters). Pre-commercial drug product development; fill and finish. Raw materials and finished product physical and chemical testing using compendial methods (USP, EP), dissolved and head-space oxygen and API/excipient/preservative analysis., Quality: QA and QC, Batch record review and lot release, stability program management and outsourced testing, product and raw materials testing and release., MS Office, statistics/graphics (JMP, Prism)., Critical thinking and decision making, problem solving and troubleshooting on compressed timelines for multiple projects, experimental design (DOE), group lead and laboratory/project management, collaboration on cross-functional groups, technology transfer and liaison for off-site vendors/contract services, fast learner, follow-through on tasks, wide and varied experience and skill sets in biotechnology, science, engineering, and remodeling/construction contracting.