Senior Manager/Associate Director QC Scientist – Analytical, Late Stage Development, Process Excellence

Role Overview

• 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.
• Perform statistical analyses to support method validation, qualification studies, and critical material qualification.
• Ensure system suitability and ongoing method performance monitoring.
• Author and review GMP documentation, including:
• Method transfer protocols and reports, as required
• Validation protocols and reports
• Test methods and best-practice documents
• Maintain comprehensive documentation of validation and transfer activities.
• Contribute technical content to global regulatory filings supporting clinical development.
• Partner closely with Analytical Development, MS&T, Quality Assurance, and external testing laboratories.
• Lead training for new analytical methods at external labs and support QC analysts in execution, data analysis, and technical review.
• Present analytical findings and critical issues to cross-functional teams and leadership.

Requirements

• 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.

Benefits

• Health insurance with FULL premium coverage
• 401K with company match
• Employee Stock Purchase Program (ESPP)
• Competitive paid time off (PTO)
• Company-paid short & long-term disability insurance and life insurance