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

About Aura:

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.

Position Summary:

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.

Key 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, 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.

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:

• 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.

Qualifications

• 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

Salary & Benefit Information:

Salary Range: $150,000/yr - $215,000/yr

(Placement within the listed range depends on many factors including, but not limited to: geographic location, degree, years of experience, and internal company equity)

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