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Hybrid Senior Manager/Associate Director QC Scientist – Analytical, Late Stage Development, Process Excellence
Posted 4 weeks ago
About the role
- Senior QC Scientist at Aura Biosciences supporting late-stage product development and driving Process Excellence initiatives. Collaborating with cross-functional teams and managing analytical method validation.
Responsibilities
- 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
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