Analytical Expert - Pharma Products

Location Requirement:

This position is based on the US East Coast (candidates should ideally live within a reasonable distance of Raleigh, NC, or Boston, MA).Key responsibilities:Ensure compliance and relevance of analytical methods (IPC, DS, and DP) and associated Quality Systems, including specifications, for a small molecule product, and all relevant regulatory and legislative requirementsResponsible for overseeing and managing development as well as analytical routine activities at CLO/CMO; incl. release testing and stability studies, investigating and solving issues and queriesSupport in the design of stability study programs, assessing shelf life, and ensuring the relevance of analytical methodsResponsible for continuous method verification, including analysis of trend data, establishing and reviewing method lifecycle to maintain, develop, and validate analytical methods to support quality and process understandingLead analytical transfer workstreams for drug substance and drug product transfers from development to commercial sites and between commercial sites, method qualifications, and validations, and provide training for external labs.Support the development, refinement, and implementation of the product control strategy by ensuring analytical method capabilities, specifications, and stability data are fully aligned with quality and process understandingLead internal activities related to external manufacturing, such as assessments of analytical changes, major/critical deviations, risk assessments, and CAPAsOversee the establishment and maintenance of reference materials and responsibility for product-specific method standards and qualified materials (critical reagents), including coordination of shipping of samples and reagentsWrite and review applicable sections in registration files, variations, and market expansionIssue, review, and approve applicable internal and external SOP's. Keep up to date with relevant regulatory and legislative requirements and assessment of testing monographsProvide support for geographical expansions to new marketsSupport process and system improvements to allow effective work within Analytics