Business Development Management for an international pharmaceutical/therapeutics company

-English language editing for scientific and technical journals. International Sales and Business development (Brazil, China, and Europe)

Key Account Manager in charge of managing two client's accounts, from an scientific, business and regulatory perspective; while following local, and international standards and guidelines (IVDR, ISO 13485, ISO 14971 etc..)

Regulatory affairs implementation and management. Project management overview.

-Planning, controlling, recruiting and organization

-Protocol development, standardization, training, organization and maintenance.

-Develop research projects including protocol design, budget preparation and justification, data collection and analysis and data storage. - Supervise research assistants and monitors budgets. Responsible for record keeping, inventory and equipment management. - Assist in the preparation and submission of grant applications including budget preparation and justification. Obtain approval for research projects from review committees. Assist in manuscript preparation. -Plan and implement training programs for Research Assistants on research activities and practice including grant application, budget management, data analysis, record keeping and scientific integrity. -Maintain and expand research expertise by acquiring new research techniques and keeping abreast of new knowledge. -Effectively communicates progress of research projects via meetings with, and written reports to, research investigators. -Conduct research in a manner that maintains and promotes scientific integrity, and ensure that research projects and environment comply with all applicable laws and regulations. -Responsible for following the mandatory reporting procedures for any incident or serious event that did affect or potentially could have affected the clinical care of any patient. Standard Responsibilities -Performs in accordance with system-wide competencies/behaviors. -Performs other duties as assigned.

- Sales and Business Development- Customer satisfaction, troubleshooting-Preparation of custom cloned and fluorescently tagged full length human and murine genes as developmental reporters for the research and biotech community- Protocol development for streamlining production- Training summer interns in basic lab techniquesContacting potential customers regarding product sales

-streamline and re-write SOP protocols -In charge of shipping and receiving and logistics -organization and set up

-Business Development-Commercial HIV-1 virus production; developed improved protocols for increased yields, prepared batch records, performed QA/QC; learned hazardous materials handling protocols, and prepared shipments according to DOT, IATA, and IMDG protocols- Trained new employees in GLP and GMP- Real-time PCR-based diagnostics for quantitation of viral yields- Performed western blots.

Team member of the initial manufacturing team charged with developing and producing commercial biological reagent kits for the Ibis T-5000 Biosensor- Developed GLP-GMP manufacturing protocols for the Ibis T-5000 Biosensor’s diagnostic reagent kits - Worked with audit control on quality assurance and quality control - Prepared kits for sale for bacterial, viral and fungal panels

- learned all aspects of 454 LifeSciences’ (Roche) FLX next generation DNA sequencing technology including: set up, library preparation, emPCR, emulsion breaking, and instrumentation handling. - completed the entire sequencing of two 6.2 Mb Pseudomonas aeruginosa genomes and performed detailed genomic comparisons.- Completed the entire sequence of a new taxon related to the Clostridia involved in cellulose degradation.- responsible for the preparation and analysis of tens of thousands of DNA clones for Sanger sequencing requiring: PCR, robotic liquid handling techniques, and gel electrophoresis. - Sequenced multiple Streptococcus pneumoniae, Staphylococcus aureus and Haemophilus influenza clinical strains.