Careers

CMC Data Scientist

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:

Aura is seeking an experienced and motivated CMC Data Scientist to join their team. They will broaden and deepen the company’s capabilities in the development and application of data analysis.

Responsibilities include but are not limited to:

  • Responsible for data analysis and reporting activities for clinical research evaluation and verification.
  • Apply visualization, analytical and data mining techniques.
  • Analyze and manage large clinical data sets using Excel, SQL, JMP or similar data analysis tools.
  • Able to examine data sets and determine the best end-to-end analysis plan to address key business questions and proactively identifies opportunities for product improvements.
  • Provide specialized functions such as algorithm development, statistical modeling, or data analysis methodology.
  • Serve as database administrator and manager of clinical data for research and development activities

Minimum Requirements:

  • Minimum 4 years in a relevant industrial setting.
  • Experienced with data analysis and software programming.
  • Able to perform proficiently under up-to-date regulatory requirements.
  • Minimum Education: BS, MS or Ph.D. in bioengineering, biomedical engineering, chemical engineering, or a relevant physical or life science. Master’s degree and above is preferred.

Desired Qualifications:

  • Experienced in data analysis and reporting activities, with strong problem-solving and critical thinking skills.
  • Capable of solving analytical problems and effectively communicating methodologies and results, to support product research and development.
  • Proficient with Statistical analysis tools.
  • Excellent communication, presentation, and organizational skills.
  • Capable of independently driving issues to resolution.
  • Collaborate effectively with internal stakeholders and cross-functional teams.
  • Clinical research experience is a plus.

Benefits and Perks:

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

Interested in applying? Please apply through our LinkedIn posting: https://www.linkedin.com/jobs/view/2948929114

CMC Project Manager

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:

Aura Biosciences is seeking a CMC Project Manager to play a critical high-level role providing strategic oversight of process transfers from internal to external contract manufacturing sites. This person is responsible for ensuring that CMO timelines for upstream, downstream, and custom starting materials manufacture stay on track.

The successful candidate will have a demonstrated track record of technical and project leadership. This is an excellent opportunity for a highly motivated self-starter and creative problem solver who has a strong desire to make an important contribution to the development of novel therapies. This is a high-profile position with the opportunity to innovate in an entrepreneurial and high growth organization.

Responsibilities include but are not limited to:

  • Overseeing the planning and execution of project activities to ensure alignment with the expectations and timelines.
  • Provide continuous support for teams to proactively plan project activities as well as track and monitor project progress.
  • Manage projects, critical path items, and project risks.
  • Develop project timelines and budgets based on detailed project plans.
  • Escalate timeline slips and risk quickly and efficiently.
  • Ability to build strong relationships and take a lead role with external collaborators on complex, multi-national research, and development stage projects.
  • Partner proactively with the Project Leader and team members to identify risks, gaps, and resource bottlenecks and then develop and implement mitigation plans.

Minimum Requirements:

  • BS degree required, MS degree or MBA preferred
  • 5-7 years prior experience with project management tech transfer to a CMO.
  • Ability to be self-disciplined and individual accountably for delivering.
  • Ability to acknowledge timeline slips and escalate in a timely matter when they occur.
  • Adaptability and positive attitude in a fast-paced environment
  • Ability to communicate effectively both orally and in writing, both internally and with external vendors and partners

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

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 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