- Conduct toxicological risk assessments on medical device/component extractable and leachable studies.- Collaborate with analytical chemistry team in design of extractable and leachable characterization studies, review testing protocols, and review reports.- Perform compositional profiling based on medical device composition to assess toxicological risk from exposure to potential leachable substances.- Support the biocompatibility scienties in writing and review of biological evaluation plans and reports; ensure compliance with applicable standards and FDA/ISO guidance documents.

Provided technical support for toxicology and biocompatibility processes to meet business objectives. Responsible for conducting toxicological risk assessments based on data derived from extractables and leachables studies, in support for new product development and sustaining activities, as well as in support of global regulatory submissions. Oversaw the design and execution of extractable and leachable studies conducted at contract research organizations.

Conducted biocompatibility assessments and biocompatibility evaluation plans and reports in compliance with applicable standards and FDA/ISO guidance documents within a risk-based framework. Responsible for the oversight of bioassay and extractable and leachable testing conducted at contract research organizations.

Responsible for the design and execution of post-market clinical evaluations of cardiac mapping catheters in collaboration with key opinion leaders in cardiac electrophysiology; determined study endpoints, authored protocols, presented study design to site directors, conducted preliminary data analysis at designated study checkpoints, and authored study reports.

- Analytical method development chemist. Subject matter expert for biological chemistry techniques, high-pressure liquid chromatography, and mass spectrometry. - Extractables and leachables testing subject matter expert. Well versed in the design and execution of studies for medical devices and their packaging materials. - Extensive knowledge in the following analytical techniques: HPLC, UPLC, LC-MS, GC-MS, pyrolysis GC-MS, ICP-MS- Experience with a variety of biocompatibility-related studies including cleaning validations, characterization of a new device, and demonstration of toxicological equivalence between next generation products and legacy products. - Analytical methodology and regulations consultant for combination product group within Abbott. Advise on the development, validation, and everyday use of assay/impurity methods, residual solvent methods, and drug elution methods.- Manager of two direct reports. Act as a mentor for their professional growth and development. Assign and prioritize work.

- Advised on the design and supported the execution of extractable/leachable characterization testing of medical devices and pharmaceutical packaging.- Developed and validated methods for the characterization of pharmaceutical and combination products; projects included HPLC analysis for drug purity and stability characterization, drug dissolution methods (App 1,2, and 3), biological sample (blood, serum, tissue) preparation (solvent extraction, protein precipitation, solid phase extraction) and analysis by LC-MS/MS.- Responsible for the oversight of data collection, interpretation, analysis, documentation, and reporting of results as well as the derivation of study conclusions.- In charge of establishing project timelines and deliverables. Offered project updates in the form of verbal communication accompanied by written documents summarizing analyses performed and subsequent results.- Developed and validated HPLC and LC-MS based assay and impurity methods as well as elemental impurity analysis methods by ICP-MS.- Principle analyst regarding the operation of HPLC, LC-MS, and ICP-MS instrumentation. - Act as a mentor for laboratory analysts. Provide training on HPLC, LC-MS and ICP-MS instrumentation as well as technical document writing.

- Trained in polymer-small molecule formulation techniques.- Created a novel biodegradable polymer containing a near-IR emitting fluorophore. Used to create microspheres to study the clearance in situ upon injection in the synovial fluid of a rat knee. - Developed HPLC and LC-MS methods for the analysis of polymer-small molecule formulations for material characterization and pre-clinical studies.- Primary analyst for the preparation and analysis of pre-clinical study samples for a pre-IND application.

- Thesis Title: Applications of substrate analogues for studies of prenyltransferase enzymes- Developed and characterized a protein bioconjugation technique based on the natural post-translational protein modification, prenylation. Applied technique towards the in situ evaluation of protein prenylation using HPLC, SDS-PAGE, and mass spectrometry.- Created a high-throughput continuous fluorescence assay for the evaluation of protein prenylation.- Utilized photo-activatable enzyme substrate analogues to study rubber biosynthesis via HPLC, SDS-PAGE, and mass spectrometry in collaboration with the USDA.

- Responsible for the care of hospitalized patients including feeding, medicating, and performance of physical therapy as needed.- Assist in routine and pre-surgical exams, sample collection, and surgical procedures.

Thesis Title: Solid-phase peptide synthesis of Kasumigamide, a novel anti-algal compound