Sr. Manager/Associate Director QC Scientist (Cell Based Assays-ELISA–Late Stage Development & Process Excellence)

Senior QC Scientist — Key Responsibilities
- Lead analytical method activities to CDMOs, including method transfer (as appropriate), validation, and authoring validation protocols/reports
- Manage and review method validation work, method performance, and any required third-party activities
- Provide on-site technical readiness support and serve as SME during validation campaigns
- Troubleshoot and resolve analytical method lifecycle/validation technical challenges with CDMOs and internal stakeholders
- Drive continuous improvement and lessons learned across Aura and vendor sites

Technical & Quality Leadership
- Monitor and trend analytical method performance with Analytical Development (AD)
- Support quality systems: 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/review GMP documentation: method transfer protocols/reports, validation protocols/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 with Analytical Development, MS&T, Quality Assurance, and external testing laboratories
- Lead training for new analytical methods at external labs; support QC analysts with 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 for biologics/advanced therapeutics, including qPCR, ELISA, potency assays, and compendial (microbiological) methods
- Strong working knowledge of FDA/EU/USP/ICH requirements and cGMP quality systems

Qualifications
- B.Sc., M.Sc., or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related field
- 10+ years pharmaceutical industry experience with significant exposure to cGMP manufacturing and late-phase method validation
- Demonstrated expertise in analytical method validation/lifecycle management, process validation support, technology transfer, and troubleshooting
- Proficiency in statistical software (e.g., JMP or equivalent)
- Strong communication/negotiation/stakeholder management; independent operation; dynamic prioritization in fast-paced settings
- Willingness to travel to CDMO sites as needed

Benefits (if applicable)
- 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