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

Role Summary

Senior QC Scientist to support late-stage product development and drive Process Excellence initiatives. Responsible for analytical readiness for commercial manufacturing through partnerships with CDMOs and cross-functional internal teams. The role requires expertise in method validation, transfer, optimization, and troubleshooting in a cGMP-regulated environment, with the ability to influence and collaborate across organizations.

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
    • 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.
• Technical Expertise
  • Subject matter expertise in analytical methods relevant to biologics and/or advanced therapeutics, including but not limited to:
    • MS
    • HPLC
    • DLS
    • CE-SDS
    • SDS-PAGE
    • Western blot
  • Strong working knowledge of regulatory requirements (FDA, EU, USP, ICH) and cGMP quality systems is required.

Qualifications

• 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

Education

• B.Sc., M.Sc., or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related scientific discipline

Skills

• MS
• HPLC
• DLS
• CE-SDS
• SDS-PAGE
• Western blot

Additional Requirements

• Willingness to travel to CDMO sites as needed