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

Aura Biosciences•Brighton, MA

1d•Hybrid

About The Position

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. Aura is seeking an experienced and highly collaborative Senior QC Scientist to support late-stage product development and drive Process Excellence initiatives. 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. This individual thrives in complex, fast-paced settings and brings both technical depth and the ability to influence and collaborate across organizations.

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

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.
Subject matter expertise in analytical methods relevant to biologics and/or advanced therapeutics, including but not limited to: qPCR ELISA Potency assays Compendial methods including microbiological methods
Strong working knowledge of regulatory requirements (FDA, EU, USP, ICH) and cGMP quality systems is required.