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Senior Scientist, Analytical Development, Drug Substance
* Develop and implement methods for in-process testing, process characterization, and release testing.
* Supervise and direct the validation of API release methods and release testing at external contract labs, working to aggressive timelines.
* Work closely with process development chemists to propose and justify specifications and release tests for GMP material.
* Work closely with process development chemists to generate and interpret analytical data to provide enhanced understanding and guidance around process chemistry reactions and downstream processing steps.
* Ensure and maintain an up-to-date familiarity with and knowledge of all relevant regulatory guidance.
* Participate in cross functional project teams focused on drug substance development activities.
* Perform or coordinate small scale isolation of impurities as well as collaborating with process chemistry groups for larger scale isolation as necessary
* Elucidate structures of impurities in intermediates, drug substances and drug products.
* Identify and execute or coordinate physicochemical testing required to characterize intermediates, drug substances to support development stage programs.
* Collaborate with non clinical development group to identify qualified impurities limits of GI/PGI’s, process and degradent impurities as well as investigating test article strategies for qualifying drug substance and drug product related impurities during toxicology studies.
* Collaborate with drug substance development groups to review manufacturing process schemes to identify potential genotoxic impurities, and identify testing points and control strategies
* Conduct stress studies to understand degradation pathways associated with development compounds and communicate relevant information to the drug substance process development and drug product development groups.
* Author structure elucidation, impurities and physicochemical technical reports and sections in regulatory filing documents.
* Assist analytical development team members focused on life cycle management of HPLC purity assays used to monitor individual impurity levels in drug substances and drug products during toxicology studies and clinical phase development.
* PhD in Analytical Chemistry, Organic Chemistry or a related discipline with a minimum of 6 years pharmaceutical/biotech experience in analytical method development and structure elucidation of pharmaceutical compounds.
* Demonstrated expertise in chromatography and separation science.
* Strong understanding of small molecule structure elucidation, guided and informed by knowledge of organic chemistry.
* Experience with HPLC method development and validation and Waters Empower software.
* Experience managing testing performed at GMP and non-GMP contract labs.
* Experience in a wide variety of structure elucidation and physicochemical techniques including mass spectrometry, 1D and 2D NMR, FTIR, GC, GC-MS, pKa, elemental analysis, ion chromatography, etc.
* Demonstrated ability to analyze and interpret analytical data.
* Strong familiarity with and understanding of USP monographs and chapters, and ICH/FDA guidance documents related to analytical method validation, impurities, genotoxic impurities, etc.
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