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.
The Principal Scientist-Characterization is a key strategic and leadership role in the Analytical Development (AD) Department at Aura where the candidate will contribute by planning and performing product characterization through development of state-of-the-art analytical methods and generating data to meet regulatory expectations for the Biological License Application (BLA) of the lead Aura product, AU-011. The data will be used in the module 3 Product Characterization and hence the successful candidate will bring the expertise to develop the characterization plan and draft the dossier section.
Demonstrable knowledge in multiple cutting edge analytical technologies and specific expertise in LC and Mass Spectrometry is important. The candidate needs to be an excellent communicator and prior knowledge in managing CROs to get the work done within very aggressive timeline.
This role is expected to spend 50% time at the bench and the remaining time managing characterization work with collaborators (academics/CROs).
Responsibilities include but are not limited to:
- Act as the subject matter expert in Analytical Development to support all analytical characterization work for drug substance and drug product
- Collaborate with Contract Research Organization (CROs) and Contract Testing Laboratories (CTLs) to support product characterization activities during late-stage development including process validation batches.
- Design studies with internal Analytical Development and CROs/CTLs for virus like particle (VLP) and small molecule analytical characterization to support product licensing
- Develop and execute Reference Standard material qualification strategy with Quality Control
- Independently design and manage execution of experiments at external partners to generate robust analytical data, and work collaboratively with CDMO/CROs on design and execution of experiments
- Author and review technical protocols and reports, CMC regulatory sections, assay summaries, study design and protocols, SOPs, etc.
- 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., Pre-clinical Research, Process Development, Quality Control, Suppliers, CDMOs, CROs etc.
- Independently analyze data, present results and conclusions to the team and senior management
- 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 areas are required: Peptide Mapping, LC/MS-MS, Flow Cytometry, FTIR, Electron Microscopy, etc.
- The ability to use and maintain LC-MS/MS instrumentation, and interpret the data generated
- Experience analyzing complex biological samples via mass spectrometry
- Good understanding of biopharma operations, GXPs, ICH guidelines, process characterization/validation and technology transfer
- Knowledge and/or Perform FTIR Spectroscopy
- People and project management skills
- Strong communication skills
- Critical thinking and problem-solving skills
- Strong technical writing skills
- Managing multiple projects and tasks and meet deadlines with a high tolerance for ambiguity
- Author and approve comprehensive and accurate protocols/reports
- Ability to function independently and communicate cross-functionally across various departments
- Ability to manage priorities, and engage/communicate in a multidisciplinary environment
Education & Relevant Work Experience:
- PhD in a relevant scientific and biological discipline e.g., Analytical Chemistry /Biochemistry /Chemistry with 10+ years of industry experience, or master’s degree with 15+ years of industry experience
- Experience in analytical development and characterization 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
- Free parking
Physical & Travel Requirements:
- Travel to CTLs and CROs, as needed (<20%)
Interested? Please apply through our LinkedIn posting: https://www.linkedin.com/jobs/view/3189881500