QC Scientist – Method Validation & QC Operations bei Aura Biosciences

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 Biosciences is seeking a highly motivated and detail-oriented QC Scientist to support method validation and routine QC operations for our innovative oncology therapeutics. This role is critical to ensuring the integrity and compliance of analytical methods used in the testing of drug substance and drug product across clinical stages.

Key Responsibilities:

• Lead and execute method qualification and validation activities in alignment with ICH guidelines and GMP standards.
• Support and oversight of routine QC testing of plasmid, drug substance (DS) and drug product (DP), including release and stability studies.
• Collaborate with CMOs and CROs to ensure timely and compliant execution of analytical activities.
• Author and review technical documentation including validation plans, protocols, reports, SOPs, and CoAs.
• Manage validation timelines and proactively provide solutions to method challenges.
• Participate and lead investigations (OOT/OOS), CAPAs, and continuous improvement initiatives.
• Review and trend analytical data routinely for specification evaluation.
• Ensure compliance with internal quality systems and regulatory expectations.
• Contribute to cross-functional CMC discussions and provide technical input on overall analytical strategy.

Key Skills

• Analytical Method Validation – Strong understanding of ICH Q2(R2), GMP principles including compendial methods and data integrity.
• Instrumentation Expertise – Proficiency in HPLC, UV-Vis, Empower, Bioassays, qPCR other analytical platforms and compendial methods.
• Collaboration – Effective communication with internal teams and prior experience managing external partners (CMOs/CROs) is preferred.
• Technical Writing – Skilled in drafting and reviewing protocols, reports, and SOPs.
• Problem Solving – Experience with OOS/OOT investigations and root cause analysis.
• Project Management – Ability to manage timelines and deliverables across multiple stakeholders.
• Regulatory Knowledge – Familiarity with FDA and EMA expectations for QC and validation.
• Attention to Detail – High level of accuracy in data review and documentation.
• Statistical analysis using JMP, Minitab or equivalent.
• Minimal travel is required to CMOs.
• Role is a hybrid role (minimum 3 days onsite).
• Minimum BS in Sciences with at least +5 years’ experience or MS and 2+ years

Salary & Benefit Information:

Salary Range: $105,000/yr - $135,000/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