Develop, qualify, and troubleshoot chromatographic (GC, HPLC/UPLC) and LCMS based methods for the identification, characterization, and impurity profiling of oligonucleoProducts, siRNAs, and their formulations, as well as raw material related analytical methods and other methods as needed.
Understand and apply advanced scientific principles, theories, concepts, practices and standards to process and analytical development.
Provide analytical support for investigations leading by quality, manufacturing, supply chain.
Perform testing of late development siRNA candidates and their formulations for their characterization.
Author method development and qualification reports and SOPs for test methods. Evaluate suitability of new methods and oversee method qualification and validation in the external contract testing labs.
Author and review analytical sections in regulatory submission documents.
Apply strong technical knowledge of organic and analytical chemistry to support laboratory investigations (deviations/OOS/OOT), as needed.
May serve as a primary contact person for cross-departmental needs or projects and be accountable for key deliverables.
Contribute to the development and/or improvement of technical capabilities as well as initiatives to improve department efficiency.
Qualifications
PhD in Chemistry, Biochemistry or related disciplines with 0-4 years industry experience, Master’s degree with > 5 years related industry experience or Bachelor’s degree with > 8 years related industry experience respectively, with demonstrated chromatographic separation, method development / qualification and structure elucidation expertise.
Experience with HPLC/UPLC and LCMS-based analytical method development desired.
Hands-on experience with oligonucleoProducts, proteins, or pepProducts is a plus.
Familiarity with instrument troubleshooting and software including Empower, MassHunter, and UNIFI preferred.
Knowledge of GxP requirements and application of statistical methods in the analytical laboratory is a plus.
Strong interpersonal skills, communication, and collaboration.
