Sr. Manager/Associate Director QC Scientist (Analytical–Late Stage Development & Process Excellence)

Key Responsibilities

• Analytical Method Life Cycle Management & Validation
• 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.

Technical & Quality Leadership

• 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.

Documentation & Regulatory Support

• 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.

Cross-Functional Collaboration & Training

• 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.

Qualifications

• 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.

Salary & Benefit Information

Salary Range: $150,000/yr - $215,000/yr (Placement within the listed range depends on many factors including, but not limited to: geographic location, degree, years of experience, and internal company equity)

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