Careers

Principal Scientist (Biochemistry / Molecular and Cell Biology)

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.

Title:

Principal Scientist (Biochemistry / Molecular and Cell Biology)

Location:

Based in the Company’s North Cambridge office with <10% travel required.

Duties:

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 15-40% at the bench.

  • Act as the subject matter expert in analytical science to support potency, impurity, identity 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

  • Develop reference standard material qualification strategy with Quality team

  • Independently 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

Requirements:

Knowledge, Skills & Capabilities:

  • In depth understanding and hand on experience in one or more of the following area is required: qPCR, ddPCR, cell-based assay, potency assay, TCID50, ELISA, SDS-PAGE, western blot, bioburden, endotoxin, virus screen, electron microscopy, 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/PhD degree (PhD preferred) in a relevant scientific discipline e.g. Molecular/Cell Biology, Biochemistry, Virology, PhD with 4-6 years of industry experience, MSc 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%)

 How we Work:

Aura is powered by a passion for bringing together diverse people, ideas and technologies behind common purpose: to create breakthroughs in diseases with significant unmet medical needs.  We constantly seek opportunities to broaden our impact and reach, using new platforms and technologies, and partnering to ensure that our drug development expertise reaches its full therapeutic potential.

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