About Aura:

At Aura, our mission is to develop a new class of oncology targeted therapies that deliver meaningful therapeutic benefit to a range of cancer indications with high unmet need in which we believe we can establish a new standard of care. We are driven by our passion and commitment to science and the patients battling cancer who are relying on us to pioneer these new therapies.

We are focusing the initial development of our VDC technology platform to treat tumors of high unmet need in ocular and urologic oncology. AU-011, our first VDC candidate, is being developed for the first line treatment of primary choroidal melanoma, a rare disease with no drugs approved. Beyond primary choroidal melanoma, we are developing AU-011 in additional ocular oncology indications, including choroidal metastases. Leveraging our VDCs’ broad tumor targeting capabilities, we also plan to initiate a clinical program in non-muscle invasive bladder cancer, or NMIBC, our first non-ophthalmic solid tumor indication.

Position Summary:

Reporting to the Upstream Process Development Lead, the (Sr) Associate Scientist will be responsible for the development of upstream production processes and the production of material for routine in-house development use. This includes all assays associated with cell culture production. The incumbent will also participate in the transfer of the upstream process to support biopharmaceutical product development at Contract Manufacturing Organizations (CMOs). 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 3 years, or M.S. plus 1 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 JMP 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. Any chromatography (AKTA systems) and filtration experience is a plus.
• Experience with various analytical procedures is a plus (SDS-PAGE, western blot, ELISA, HPLC, etc.)
• 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.
• An understanding of current good manufacturing practices (cGMPs) as they apply to the development and qualification of biological processes.
• Proficient in Excel, PowerPoint, and Word applications.