About Aura:
Aura Biosciences is a clinical stage oncology company. We are developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively, while activating the immune system to create long lasting anti-tumor immunity.
We have a goal of developing this technology in multiple cancer indications, focusing initially on two therapeutic areas – ocular oncology and bladder cancer – with a goal to expand into other areas of solid tumor oncology. Initially we have focused our clinical development in the medical field of ocular oncology, a group of rare diseases that have no drugs approved. We are in Phase 3 with our lead VDC AU-011 in choroidal melanoma. We are also in development in non-muscle invasive and muscle invasive bladder cancer, currently in a Phase 1 trial.
We have commenced a global Phase 3 program investigating the delivery of AU-011 for the treatment of small choroidal melanoma and indeterminate lesions. AU-011 has to date demonstrated an excellent efficacy and safety profile in Phase 2 for choroidal melanoma, and enrolment is ongoing in the pivotal Phase 3 trial.
Position Summary:
This role on the Analytical Sciences (AS) team contributes to Aura’s efforts to develop safe and effective therapies using virus-like particle (VLP)-based technologies. This role is expected to spend 80% at the bench.
Responsibilities include but are not limited to:
- Performing assays routinely, e.g., cell-based potency assays, ELISA based assays, binding assay (SPR)-based), protein quantitation assays, gel electrophoresis, etc.
- Supporting development of cell-based and immunoassays for biological products
- Data trending and analysis using logistic fitting methods, including software platforms for statistical analysis and presentation.
- Other analytical methodologies relevant to qualitative and quantitative characterization of proteins or nanoparticles (e.g., UV/Vis, surface plasmon resonance (SPR), Octet, etc.)
- Perform testing of routine development, investigational and trouble-shooting samples for multiple assays upon successful training.
- Perform product characterization, method qualification to support development release testing, stability studies.
- Author and review technical protocols and reports, assay summaries, study design and protocols, SOPs, etc.
- Ensure accurate and complete documentation of any scientific experimental plan, data and report.
- Establish and maintain familiarity with contemporary industrial standards, practices, technologies, literature and ways of performing lab studies.
Minimum Requirements:
Knowledge, Skills & Capabilities:
- Hands-on experience with analytical method development and/or method qualification
- In depth understanding and some hands-on experience in one or more of the following areas is required: Cell-Based cytotoxicity or potency assay, ELISA, spectroscopy (UV/Vis), binding affinity (SPR, Octet, etc.), SDS-PAGE, nanoparticle analysis (NTA, DLS, flow imaging, etc.)
- Fundamental understanding of analytical method development, qualification, validation, and transfer to other sites
- Strong communication, critical thinking, technical writing, and problem-solving skills
- Knowledge of statistical methods for DOE design and data analysis (e.g., JMP) is a strong plus.
- Ability to author comprehensive and accurate protocols/reports.
- Ability to select, implement and use appropriate data management concepts and tools.
- Ability to function independently, manage priorities and engage/communicate cross functionally across various teams and meet deadlines with a high tolerance for ambiguity.
Education & Relevant Work Experience:
- A MSc degree in a relevant scientific discipline e.g., Analytical Chemistry/Biochemistry, or a BSc degree with 2+ years of biotech industry experience is needed.
- Experience in analytical development and testing of antibody-drug conjugate, viral vectors or other biologics would be required.
- Experience performing cell-based assays, ELISA-based assays, gel electrophoresis and protein quantitation assays is important.
Physical & Travel Requirements:
- Travel to CTLs and CDMOs, as needed (<10%)