- PhD in Analytical Chemistry, with 8 years Senior-level experience in the US pharmaceutical industry.
- Successful at building strong professional relationships. Manages large and complex projects while maintaining high team morale and energy. Skilled mentor and mediator who excels at bringing out the best in team members.
- Chemist versed in bio-analytical method development, validation sample analysis. Practiced in instrument monitoring and analytical method performance.
- Expert in bioanalysis
- CRO, FDA, GLP and R&D laboratories
- Bioanalytical method development, validation and sample analysis
- LC/MS, GC/MS, Immunoassay, ELISA
- Participant in multi-functional teams
- Strong commitment to staff mentoring and development
- Supervisory skills
- Project management
•Principal Investigator: Took the primary responsibility for all aspects of the execution of projects assigned with regulatory implications.
•Project Management: Responsible for the analytical method, sample tracking, staff duty assignments and training, procurement of necessary supplies, obtaining and scheduling resources, conducting studies, quality control, data review and reporting of studies as assigned.
•Method Development (LC-MS/MS, GC-MS/MS and Immunochemistry): Responsible for the development and validation of analytical methods for quantitation of analytes in biological matrices, to include sample preparation, optimizing assay parameters and interpretation of results.
•Laboratory Operations (LC-MS/MS, GC-MS/MS and Immunochemistry): Daily laboratory operations included troubleshooting of analytical equipment and methods, quality control, data review, preparation of reports and protocols, drafting and review of SOPs, logs and investigation reports, support instrument IQ/OQ/PQ and re-qualification.
•Supervision: Daily interaction with analysts and report coordinators to establish priorities and assignments. Provided training required enabling the analysts and detailed planning to maximize efficient use of time. Resolved technical difficulties and documentation issues associated with method development, sample analysis, data review, GLP compliance, operational processes and policies
•Training and Staff Development: Contributed to the improvement and implementation of the training program of all members of the team including analysts, reporting staff and new senior scientists.
•Contributed to activities associated with analytical, bioanalytical, and formulation development efforts, as well as hiring and supervision of analytical scientists.
•Performed HPLC and CE method development and pre-validation for specific products (large and small molecules) and gel microbicide formulations.
•Performed laboratory work including experimental organization and implementation, drug product formulation (topical gel), sample analysis, data review, statistical analysis and results presentation. Performed Instrument IQ/OQ/PQ and re-qualification.
•Served as a technical liaison with external organizations involved in analytical/bioanalytical method development, validation, transfer and testing efforts.
•Assured accurate record keeping, reporting of data, and storage of information related to analytical/bioanalytical development efforts, in addition, provide all required scientific/technical documentation including reports, SOPs, etc.
•Provided technical support regarding analytical/bioanalytical chemistry for the pre-clinical, manufacturing, clinical and regulatory functions, which includes support for GLP and GMP activities as well as assisting with the preparation of INDs and NDAs
•Qualified as a certified trainer for SOPs and methods.
•Contributed to scientific publications, presentations, and grants.
•Contributed to the development and protection of new intellectual property.
•Acted as a consultant regarding the development of promotional materials for clients in the pharmaceutical industry.
•Obtained competitive promotional materials via conventions and seminars.
•Developed monthly reviews of publications and clinical studies to be summarized and sent to Client for further consideration.
•Investigated the structure, biology and molecular interactions of Perlecan, a major heparan sulfate proteoglycan (PG), in basement membranes, which has been linked to tumor invasion, metastasis, and angiogenesis.
•Determined binding partners for Domain V of the extra cellular matrix proteoglycan, perlecan, using a yeast two-hybrid system.
•Cloned, expressed, and purified recombinant progranulin protein, a secreted growth factor, to be used as a novel binding partner for perlecan, in order to determine the effects of this interaction on tumor growth.
•Performed a mutational analysis of the laminin-G like domains of perlecan by expressing and purifying various mutant proteins and studying them in order to determine differences in protein function.
•Performed mutation of Domain V in order to produce a protein resistant to proteases
•Supervised and trained graduate and undergraduate students.
•Performed chemical (sugars, polyphenols, organic acids, pH) and biochemical (total protein, polyphenol oxidase and peroxidase activities) characterization of Spanish-grown raspberry and blackberry fruit cultivars by analyzing the effects of freezing and frozen storage on these berry fruits in order to investigate their association with the prevention of cancer, cardiovascular disease, diabetes and hypertension.
•Developed methods using design of experiment approach to extract, separate, and analyze pigments, organic acids, and sugars in different vegetal matrices to examine the differences among various fruit cultivars
•Characterized proteins involved in degradation processes in fruits, by studying their kinetics, activities, and total protein content.
•Investigated the relation between phytochemical compounds and antiradical efficiency by principal component statistical analysis.
•Performed data acquisition (phytochemicals, antioxidant and enzymatic activity, sensorial analysis, physical properties) and statistical analysis to determine significant differences between varieties and processes.
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