Research Scientist

• Lead external method development, optimization and qualification/validation efforts across liquid chromatography, capillary electrophoresis, spectrophotometric and bioassay (among others) for release and stability testing of clinical trial materials.
• Manage multiple non-GMP and GMP stability studies for drug substance (DS) and drug product (DP) batches for multiple programs.
• Leverage stability data to project shelf-life of both DS and DP supply through trending analysis.
• Develop strategies to establish characterization and comparability packages across various DS/DP lots.
• Support process and manufacturing teams towards implementation of relevant analytical methods.
• Work closely with cross-functional stakeholders (QA, Regulatory, Clinical Supply Chain) for shelf-life extension of clinical material to support ongoing clinical trials.
• Partner with internal and external stakeholders to justify and establish DS/DP protocols and specifications.
• Work with CDMO partners to perform root cause analysis and investigations to support OOS/OOT results that may arise during stability studies.
• Contribute to IND/BLA sections pertaining to analytical methods, stability studies, characterization and analytical comparability.
• Lead the diligence process to select clinical and commercial CDMO vendors.
• Partner with operations, legal, and finance groups to finalize confidentiality, master service and contractual agreements.
• 20-25% travel in support of diligence and campaign execution at the CDMOs.

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