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 15-40% at the bench.
Responsibilities include but are not limited to:
- 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 support 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 data, scientific experimental plan, and report
- Build and maintain good working relationships with internal and external stakeholders e.g. Research, Development, Quality, suppliers, CDMOs, CTLs 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
Knowledge, Skills & Capabilities:
- In depth understanding and hands 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
- The ability to use and maintain LC-MS instrumentation, and interpret the data you generate
- Experience analyzing complex biological samples via mass spectrometry
- Good understanding of biopharma operations, GxPs, ICH guidelines, process characterization/validation and technology transfer
- Perform FTIR Spectroscopy
- 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)
Aura offers a great benefit package which includes:
- Health insurance with FULL premium coverage
- 401K with company match
- Competitive Paid time off (PTO)
- Company-paid short & long-term disability insurance and life insurance
- Daily in-office lunch provided
- Free parking
Physical & Travel Requirements:
- Travel to CTLs and CDMOs, as needed (<10%)
Interested? Please apply through our LinkedIn posting: https://www.linkedin.com/jobs/view/2893319332