Principal Research Associate, Analytical Science & Technology

Here’s What You’ll Do

Provide project management and coordination support for analytical method-related activities across late-phase development and commercial programs, including maintaining timelines, trackers, action logs, deliverable lists, and status updates. Support planning, execution tracking, and follow-up for analytical method validation, transfer, verification, and lifecycle management activities to ensure alignment with internal expectations, regulatory requirements, and program milestones. Coordinate with internal laboratories, external testing partners, Quality, Regulatory CMC, and program teams to support timely execution of analytical method activities and resolution of documentation or data package gaps.

Contribute to analytical method transfer activities across internal and external laboratories by supporting transfer planning, documentation preparation, protocol/report review, readiness tracking, and follow-up on open items. Author and revise analytical documentation, including validation plans and strategies, protocols, reports, transfer documents, method summaries, technical memos, gap assessments, and supporting documentation. Support lifecycle management of commercial analytical methods, including documentation updates, method governance support, change control documentation, continuous improvement activities, and tracking of post-implementation actions.

Assist with compiling, organizing, and reviewing analytical documentation and data packages in support of regulatory submissions, health authority responses, post-approval commitments, and commercial readiness activities. Contribute to regulatory query responses by gathering technical inputs, coordinating cross-functional reviews and tracking deliverables through completion. Support analytical method gap assessments to identify documentation, validation, transfer, or lifecycle management needs for late-phase development, regulatory filing, and commercial implementation.

Maintain well-organized records, trackers, and supporting documentation to promote traceability, inspection readiness, and effective knowledge management across analytical CMC activities. Support meeting preparation and follow-up, including agenda development, meeting