Technical Lead

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 requirements
• Responsible 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 queries
• Support in the design of stability study programs, assessing shelf life, and ensuring the relevance of analytical methods
• Responsible 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 understanding
• Lead 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 understanding
• Lead internal activities related to external manufacturing, such as assessments of analytical changes, major/critical deviations, risk assessments, and CAPAs
• Oversee 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 reagents
• Write and review applicable sections in registration files, variations, and market expansion
• Issue, review, and approve applicable internal and external SOP's.
•  Keep up to date with relevant regulatory and legislative requirements and assessment of testing monographs
• Provide support for geographical expansions to new markets
• Support process and system improvements to allow effective work within Analytics