(Sr) Associate Scientist, Analytical Development

Aura Biosciences•Brighton, MA

About The Position

Aura Biosciences is a clinical-stage biotechnology company developing bel-sar, a potentially transformative, first-in-class therapy for patients living with ocular cancers. Bel-sar represents an entirely novel approach to treating ocular cancers via its dual mechanisms of action of acute tumor necrosis and secondary anti-tumor immune activation. The Phase 3 registration study of Bel-sar in early choroidal melanoma, the largest patient segment of uveal melanoma, is fully enrolled, and earlier stage studies in metastases to the choroid and cancers of the ocular surface are ongoing. Aura's mission is to improve outcomes for patients living with ocular cancers by delivering a therapy that not only arrests tumor growth but also preserves vision and quality of life. The (Sr) Associate Scientist, Analytical Development will support analytical development and characterization activities for complex biologics, with a focus on virus-like particles (VLPs) and dye-conjugated VLPs. This is a primarily laboratory-based role requiring hands-on experience with molecular biology, electrophoresis, and bioanalytical techniques supporting late-stage clinical drug substance and drug product development. The successful candidate will work closely with Analytical Development scientists to execute analytical testing, support method development, qualification, and transfer activities, maintain high-quality documentation, and ensure laboratory instruments are ready for use. The role also involves collaboration with internal cross-functional teams and external partners, including contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs).

Requirements

Bachelor’s degree in Molecular Biology, Cell Biology, Biochemistry, Biotechnology, Chemistry, Chemical Engineering, or a related scientific discipline.
2-4 years of relevant laboratory experience demonstrating hands-on experience with molecular biology techniques, including DNA/RNA extraction, nucleic acid quantification, PCR or qPCR, and agarose gel electrophoresis.
Experience in aseptic techniques is required with proven experience in regular cell maintenance techniques.
Performance of cell-based cytotoxicity assays.
Demonstrated ability to independently execute, document, analyze, and troubleshoot electrophoresis and qPCR experiments.

Nice To Haves

Motivation to learn and grow and ability for problem solving is highly desirable.
Experience with one or more additional analytical techniques, such as SDS-PAGE, Western blotting, capillary electrophoresis, ELISA, UV/Vis spectroscopy, or HPLC/UPLC is preferred.
Understanding of analytical method development, qualification, validation, and technology transfer principles.
Experience working in a regulated laboratory environment and applying good documentation and data-integrity practices.
Experience supporting the analytical development or characterization of biologics, including drug substance and drug product.
Familiarity with scientific data analysis, graphing software, and basic statistical concepts.
Some travelling maybe required to assist with assay establishment, troubleshooting at CDMOs

Responsibilities

Perform laboratory experiments independently following established protocols to support inter-departmental teams, analytical method development, qualification, transfer, and product characterization.
Independently culture, maintain, expand, and cryopreserve cell lines in accordance with established protocols and quality standards.
Maintain cell banks and accurately document passage history and inventory records.
Perform cell-based cytotoxicity, molecular biology, and immunoassays to support product release, characterization, development, stability, and forced degradation studies, including DNA/RNA extraction, qPCR quantification, ELISA, and Gel electrophoresis (SDS-PAGE, Western blotting).
Collaborate effectively with cross-functional teams to meet project timelines.
Identify, investigate, and resolve technical challenges, experimental deviations, and assay performance issues as needed.
Communicate findings to appropriate scientific team members.
Serve as a subject domain lead for assigned techniques to identify atypical trends and providing technical guidance, as applicable.
Operate, maintain, and troubleshoot routine laboratory instruments used for molecular biology, bioassay, and analytical testing.
Maintain accurate, timely, and compliant records in electronic laboratory notebooks in accordance with good documentation practices and data-integrity requirements.
Prepare and review technical documentation, including data packets, standard operating procedures, test methods, and method development reports.
Participate in data review and scientific discussions related to analytical development and product characterization studies and present experimental results and scientific findings to internal and external stakeholders, as appropriate.