Technical Lead at Sobi

Location Requirement: This position is based on the US East Coast (candidates ideally live near Raleigh, NC or Boston, MA). Key responsibilites: • 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 to oversee and manage development as well analytical routine activities at CLO/CMO; incl. release testing and stability studies, investigate and solve issues and queries • Support in the design of stability study-programs, assessing shelf life and ensuring relevance of analytical methods • Responsible for continuous method verification including analysis of trend data, establishing and review method lifecycle to maintain, develop and validate analytical methods to support quality and process understanding • Lead the analytical transfer workstreams of drug substance and drug product transfers from development to commercial site and between commercial sites, method qualifications as well as validations and provide training of 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 to improvements for processes and systems to allow effective work within Analytics