Aura Biosciences
Sr. Manager/Associate Director QC Scientist (Analytical–Late Stage Development & Process Excellence)
Brighton, Massachusetts · Director
Sponsorship not specifiedDetected 33 days ago
Data AnalysisStakeholder ManagementNegotiationGMPFDA RegulatoryMass SpectrometryProtein AnalysisWestern BlottingLeadershipCommunicationCollaboration
About the role
- This role is critical to ensuring analytical readiness for commercial manufacturing through strong partnership with Contract Development and Manufacturing Organizations (CDMOs) and cross-functional internal teams.
- The ideal candidate is a seasoned analytical chemist with deep expertise in method validation, transfer, optimization, and troubleshooting in a cGMP-regulated pharmaceutical environment.
- Analytical Method Life Cycle Management & Validation
Responsibilities
- Lead analytical method activities to CDMOs, including transfer as appropriate, validation and authoring validation protocols and reports.
- Drive continuous improvement and lessons learned initiatives across Aura and vendor sites.
- 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.
- Documentation & Regulatory Support
Requirements
- Minimum of 10 years of pharmaceutical industry experience, with significant exposure to cGMP manufacturing and late-phase method validation
- Demonstrated expertise in:
- Proficiency in statistical software (e.g., JMP or equivalent)
- Ability to operate independently, prioritize dynamically, and succeed in a fast-paced environment
- Manage and review work performed under method validation protocols, method performance, and any required third party activities.
- Method transfer protocols and reports, as required
- B.Sc., M.Sc., or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related scientific discipline
- Analytical method validation and lifecycle management
- Process validation support
- Technology transfer and troubleshooting
- Strong communication, negotiation, and stakeholder management skills
- Willingness to travel to CDMO sites as needed
- Salary & Benefit Information:
Compensation
- $150,000/yr - $215,000/yr
- 401K with company match
Benefits
- Health insurance with FULL premium coverage
- Employee Stock Purchase Program (ESPP)
- Competitive paid time off (PTO)
- Company-paid short & long-term disability insurance and life insurance
- (Placement within the listed range depends on many factors including, but not limited to: geographic location, degree, years of experience, and internal company equity)
Company info
- Aura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors that aim to preserve organ function.
- Our lead candidate, bel-sar (AU-011), is currently in late-stage development for primary choroidal melanoma and in early-stage development in other ocular oncology indications and bladder cancer.
- Aura Biosciences is headquartered in Boston, MA.
- Our mission is to grow as an innovative global oncology company that positively transforms the lives of patients.
- For more information, visit aurabiosciences.com.
- Follow us on X (formerly Twitter) AuraBiosciences and visit us on LinkedIn.
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