Lead analytical method activities to CDMOs, including transfer as appropriate, validation and authoring validation protocols and reports.
Manage and review work performed under method validation protocols, method performance, and any required third party activities.
Provide on-site technical readiness support and serve as SME during validation campaigns.
Troubleshoot and resolve technical challenges related to method life cycle management and validation in partnership with CDMO and internal stakeholders.
Drive continuous improvement and lessons learned initiatives across Aura and vendor sites.
Monitor and trend analytical method performance in collaboration with Analytical Development (AD).
Support quality systems activities, including change controls, deviation investigations, CAPAs, OOS investigations, and method improvements.
Author and review GMP documentation, including: Method transfer protocols and reports, as required; Validation protocols and reports; Test methods and best-practice documents.

B.Sc., M.Sc., or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related scientific discipline
Minimum of 10 years of pharmaceutical industry experience, with significant exposure to cGMP manufacturing and late-phase method validation
Demonstrated expertise in: Analytical method validation and lifecycle management, Process validation support, Technology transfer and troubleshooting
Proficiency in statistical software (e.g., JMP or equivalent)
Strong communication, negotiation, and stakeholder management skills
Ability to operate independently, prioritize dynamically, and succeed in a fast-paced environment
Willingness to travel to CDMO sites as needed.

Senior Manager/Associate Director, QC Scientist – Cell Based Assays, ELISA – Late Stage Development & Process Excellence

Key skills