Associate Scientist – Analytical Sciences

About Aura: At Aura Biosciences, we are developing a new class of therapies to target and destroy cancer cells selectively, while leaving surrounding tissue unharmed – an approach we call molecular surgery.  By safely eliminating cancer locally, we can treat early and transform the lives of people with a wide range of cancers that are poorly managed today.

Our lead program in ocular melanoma is designed to remove cancer cells in the back of the eye as a first-line therapy potentially long before the disease progresses and metastasizes to the liver, where it almost always is fatal. Development of a first-in-class treatment option to selectively destroy cancer cells would create the possibility of a cure in this and other cancers where the disease can be detected early.

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 40-60% at the bench.

Responsibilities include but are not limited to:

  • Act as the subject matter expert in analytical science to support HPLC (RP, SEC, IC), spectroscopy (UV/Vis, FTIR, Raman), binding affinity (SPR, Octet, etc.), SDS-PAGE, particle analysis (NTA, DLS, flow imaging, etc.) testing of drug substance and drug product
  • Collaborate with contract development and manufacturing organization (CDMO) and contract testing lab (CTL) to support analytical activities during process development, preclinical, clinical and potentially commercial manufacturing
  • Design studies with internal AS and Quality teams, CDMO, and CTL for VLP and small molecule analytical development, characterization, qualification, validation to support release testing, stability study, and extended characterization
  • Design and manage execution of experiments (DOE) at external partners to generate optimal and robust analytical assays and work collaboratively with CDMO on design and execution of experiments
  • Assess impact and facilitate closure of deviations, ensure appropriate scoping of change controls and CAPAs, and develop risk assessments related to analytical assays
  • Author and review technical protocols and reports, CMC regulatory sections, assay summaries, study design and protocols, SOPs, etc
  • Establish routine analytical data trending activities
  • Ensure accurate and complete documentation of any scientific experimental plan, data and report
  • Build and maintain good working relationships with internal and external stakeholders e.g. Research, Development, Quality, suppliers, contract manufacturing organizations, contract testing labs etc
  • Independently analyze data, present results and conclusions to the team
  • Establish and maintain familiarity with contemporary industrial standards, practices, technologies, literature and ways of performing lab studies

Minimum Requirements:

Knowledge, Skills & Capabilities:

  • In depth understanding and hand on experience in one or more of the following area is required: HPLC (RP, SEC, IC), spectroscopy (UV/Vis, FTIR, Raman), binding affinity (SPR, Octet, etc.), SDS-PAGE, particle analysis (NTA, DLS, flow imaging, etc.)
  • Fundamental understanding of assay development, qualification, validation and transfer
  • Good understanding of biopharma operations, GxPs, ICH guidelines, process characterization/validation and technology transfer
  • Proven project management skills
  • Strong communication skills
  • Excellent analytical thinking and problem-solving skills
  • Knowledge of statistical methods for DOE design and data analysis (e.g. JMP), experience with Quality by Design (QbD) is preferred
  • Strong technical writing skills
  • Ability to manage multiple tasks and meet deadlines with a high tolerance for ambiguity
  • Ability to manage multiple programs in matrix environment
  • Ability to lead problem solving for issues related to analytical development, qualification, validation and sample testing
  • Ability to prioritize project work and make effective use of available resource to meet agreed timelines
  • Ability to author and approve comprehensive and accurate protocols/reports
  • Ability to select, implement and use appropriate data management concepts and tools
  • Ability to function independently and communicate cross functionally across various teams
  • Ability to manage priorities, and engage/communicate in a multidisciplinary environment

Education & Relevant Work Experience:

  • A MSc degree in a relevant scientific discipline e.g. Analytical Chemistry/Biochemistry with 6+ years of industry experience, BSc with 9-11 years of industry experience
  • Experience in analytical development and testing of antibody-drug conjugate, viral vectors or other biologics (3+ years)

Physical & Travel Requirements:

  • Travel to CTLs and CDMOs, as needed (<10%)

Interested?  Email a cover letter and a copy of your CV to referencing the position description in the subject line.