Scientist/Associate Scientist – Upstream Process Development

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:

Reporting to the Process Development Lead, the Associate Scientist (or Scientist depending on qualification) will be responsible to develop and transfer the upstream process to support biopharmaceutical product development at Contract Manufacturing Organizations (CMOs). The incumbent will also support process development and validation activities at the CMO. The scientist will interact with the in-house team and the CRO/CMO to ensure timely progress in technology development, documentation, and manufacturing readiness.

Responsibilities include but are not limited to:

Process development:

  • Design, coordinate and execute process development studies utilizing multiple approaches including statistically designed experiments (DoE).
  • Design and coordinate scale-down process verification studies.
  • Design and support process characterization and optimization studies.

Technology Development and Continuous Improvement:

  • Apply and verify novel process to Aura’s unique product.
  • Improve process performance and quality of product.

Tech Transfer:

  • Support implementation of new process technologies or significant changes to processes, equipment, or manufacturing instructions.
  • Identify task list for tech transfer and support process characterization.
  • Evaluate scale up performance and recommend action items to improve scalability.

Manufacturing Support:

  • Generate continuous improvement ideas to improve documentation and business practices.
  • Support manufacturing by providing technical expertise in the manufacturing area and provide support for manufacturing investigations.
  • Compile, trend, and analyze manufacturing data from ongoing manufacturing campaigns.
  • Author process description and development reports to support tech transfer.

Other projects as assigned by management.

Minimum Requirements:

  • Degree in biochemical engineering, biological sciences, biochemistry or related discipline.
  • S. and 4+, M.S. plus 2+, or PhD with 0+ years of experience in pharmaceutical, biologics, viral production, or a related field.
  • Understanding of biologics manufacturing is required in multiple areas. Knowledge and hands-on experience including cell culture development using bioreactors and conducting transfections at varying scales.
  • Ability to critically analyze data using statistical tools and to compile technical reports.
  • Ability to accomplish projects by deadline in a dynamic environment
  • Strong oral and written communication skills. Ability to influence cross-functionally in a matrix environment.
  • Motivation in performing and learning novel process methods, and good work ethic is critical.

Desired Qualifications

  • Experience with DoE using DasGip or similar system is highly desired.
  • Virus production experience is strongly desired.
  • Cell culture experience with Mammalian and Insect cell lines is highly desired.
  • Experience with optimizing process parameters and supplementation to increase product yield and stability is strongly desired. Occasional effort may be needed in Downstream purification.
  • Experience with optimizing transfection parameters is strongly desired.
  • Experience working with 1L, 10L, and 50L bioreactors is highly desired, working with WAVE bioreactors is a plus.
  • Must have a strong understanding of what reagents and materials are frequently used to maintain inventory by ordering materials proactively.
  • Knowledge and skill in statistical design of experiments. Experience with DOE software(s).
  • An understanding of current good manufacturing practices (cGMPs) as they apply to the development and qualification of biological processes.
  • Proficient in Biocommander, JMP, Excel, PowerPoint and Word applications.

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