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:

The Scientist II / Senior Scientist will contribute to analytical development activities for complex biologics, with a focus on virus-like particles (VLPs) and dye-conjugated VLPs. This role will be focused on experimental design and execution in the lab, leading biophysical characterization, maintaining high-quality documentation, and ensuring instrument readiness. The scientist will develop, troubleshoot, and review analytical methods, author technical documentation to support CMC development. They will also collaborate with CDMOs/CROs to deliver high-quality characterization data for drug substance and drug product. Success in this role requires strong technical expertise in biophysical and separation techniques, a solid understanding of biopharma development and regulatory expectations, and the ability to work effectively in a fast-paced, collaborative environment.

KNOWLEDGE, SKILLS & CAPABILITIES:

• Expertise in biophysical analysis of virus-like particles (VLPs) is preferred.
• Analytical understanding of various biological modalities (e.g., protein-based therapeutics, conjugates, gene therapy and vaccines) is desired.
• In depth understanding and hands on experience in one or more of the following areas are required: DLS, NTA, DSC, FTIR, TEM, and flow imaging etc.
• Strong working knowledge of LC-based separation methods (e.g., SEC, RP), gel electrophoresis (SDS/WB), plate-based spectroscopy (UV/Vis), SoloVPE, and related analytical methodologies.
• Capable of managing priorities, effectively communicating across development teams, and meeting deadlines within tight timelines.
• Proficiency in drafting method development and qualification protocols, reports, and other technical documentation. Capability to design and execute fit-for-purpose methods independently.
• Understanding of biopharma operations, GxPs, ICH guidelines, process characterization/validation, and technology transfer, with a strong CMC mindset to align analytical strategies with product development and regulatory objectives.
• Problem solving ability for issues related to analytical development and sample testing.
• Effective communication, critical thinking, technical writing, and critical thinking skills
• Working knowledge of statistical methods for data analysis (e.g., JMP) is a plus.

EDUCATION & RELEVANT WORK EXPERIENCE:

• Senior Scientist: PhD in relevant scientific and biological discipline e.g., Analytical Chemistry /Biochemistry /Chemistry with 4+ years of post-doctoral/industry experience, or master’s degree with 9+ years of industry experience in relevant field.
• Scientist II: PhD in a relevant scientific and biological discipline e.g., Analytical Chemistry /Biochemistry /Chemistry with 2+ years of post-doctoral/industry experience, or master’s degree with 7+ years of industry experience in relevant field.

• Lead biophysical characterization by serving as SME, establishing methods, and designing and executing experiments to generate robust analytical data in support of CMC development.
• Maintain high quality documentation and records in electronic lab notebooks following good laboratory practices.
• Troubleshoot and resolve issues related to instruments and analytical methods.
• Maintain equipment quality through IQ/OQ, PM, and routine maintenance.
• Author technical protocols and reports, assay summaries, study design and protocols, SOPs, as required.
• Collaborate with CDMOs/CROs on the design, execution, and data review of analytical characterization studies to ensure high-quality, reliable results.
• Establish and maintain familiarity with contemporary industrial standards, practices, technologies, literature and ways of performing lab studies