Extractables and Leachables; Outsourcing

Inhalation testing. Extractables and Leachables.

Provide analytical support to the dry powder formulation team. Perform related substance and content uniformity analyses on new dry powdered technologies. Conduct particle size determination experiments utilizing cascade impaction and laser diffraction techniques. Design and execute solubility screening studies on key APIs. Evaluate data trends through the use of statistical software applications.

Performed reverse engineering studies to establish product and performance targets for potential generic pMDI products. Conducted elastomeric and container screening studies to guide the development of prospective prototypes. Developed methods for analytical testing of inhalation aerosols. Contributed to data trending and report generation in support of an ANDA submission.

Developed and validated extraction and analysis methods according to GLP specifications. Prepared biological samples for qualitative and quantitative analysis via LC/MS/MS. Provided GC/MS and LC/MS support to the DMPK and toxicology groups. Utilized tandem MS to conduct a variety of metabolite identification studies. Performed maintenance activities on instrumentation as required and in accordance with approved procedures.

Used LC/MS and GC/MS, including exact mass measurements and MS/MS, for investigating a variety of drug substance/product related issues. Investigated mass balance issues during purposeful degradation studies and leachable studies. Optimized methods or converted traditional LC methods to MS-compatible methods. Used thermal analysis techniques to investigate various properties of pharmaceutical materials. Isolated and identified trace level impurities using semi-prep LC methods.Other… Show more Used LC/MS and GC/MS, including exact mass measurements and MS/MS, for investigating a variety of drug substance/product related issues. Investigated mass balance issues during purposeful degradation studies and leachable studies. Optimized methods or converted traditional LC methods to MS-compatible methods. Used thermal analysis techniques to investigate various properties of pharmaceutical materials. Isolated and identified trace level impurities using semi-prep LC methods.Other responsibilities included method development and the qualification of inhalation-testing procedures for particle sizing and dose content uniformity, as well as HPLC assays. Performed evaluation and formulation optimization of potential inhalation products. Provided support for manufacturing validation of process and cleaning procedures. Show less