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.
Reporting to the Process Development Lead, this person will develop and transfer purification processes to support biopharmaceutical product development at Contract Manufacturing Organizations (CMOs). The incumbent will also support process development and validation activities at CMO. The scientist will interact with in-house team and CRO/CMO to ensure timely progress in technology development, documentation, and manufacturing readiness.
Responsibilities include but are not limited to:
- Design, coordinate, and execute purification 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.
- Support implementation of new process technologies or significant changes to processes, equipment, or manufacturing instructions.
- Identify tasks and activities for tech transfer and process validation.
- Evaluate scale up performance and recommend action items to improve scalability.
- 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.
- Degree in biochemical engineering, biological sciences, biochemistry, or related discipline.
- S. and 8+, M.S. plus 6+, or PhD with 2+ years of experience in pharmaceutical, biologics, viral production, or a related field.
- Understanding of biologics manufacturing is required in multiple areas including preparative chromatography techniques, normal flow filtration and tangential flow filtration techniques with depth of knowledge and hands-on experience.
- Ability to critically analyze data using statistical tools and to compile technical reports.
- Ability to accomplish projects by deadline in a dynamic environment.
- Motivated to learn and implement novel process methods, and good work ethic is critical.
- Strong oral and written communication skills. Ability to influence cross-functionally in a matrix environment.
- Experience with Akta Pure or Avant system is highly desired.
- Experience in cell culture operations is a plus. Occasional effort may be needed in USP.
- Virus production experience is strongly desired.
- Knowledge and skill in statistical design of experiments. Experience with DOE software(s).
- An understanding of current good manufacturing practices (cGMPs) as described in relevant federal code and regulatory guidance documents is desired.
- Proficient in Unicorn, JMP, Excel, PowerPoint, and Word applications.
Interested? Email a cover letter and a copy of your CV to firstname.lastname@example.org referencing the position description in the subject line.