At Aura Biosciences, we are developing a new class of therapies based on an expressed virus-like particle bioconjugate to target and destroy cancer cells selectively, while leaving surrounding tissue unharmed. 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. Come help develop a first-in-class treatment to selectively destroy cancer cells!
Reporting to the Senior Scientist, the MS&T Scientist will be responsible to develop and transfer bioproduction process 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 (included but not limited to):
Design, coordinate and execute process development studies utilizing multiple approaches including statistically designed experiments (DoE)
Design and coordinate scale-down process verification studies
Coordinate viral clearance studies at third party labs
Design at-scale process validation 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 task list for tech transfer and process validation
Evaluate scale up performance and recommend action items to improve scalability.
Write and/or review elements within CTD section 3.2 in support of regulatory filings.
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 technical reports on the quality and performance of the campaign
Other projects as assigned by management.
Bachelors or Masters in biochemical engineering, biological sciences, biochemistry or related discipline.
B.S. and 8+ , M.S. plus 4+, or PhD with 2+ years of experience in pharmaceutical, biologics, virus or a related field.
Understanding of biologics manufacturing is required in multiple areas. Experience including cell culture development using bioreactors, large scale transfection, pilot scale production. Experience with DoE using DasGip or similar system is highly desired.
Experience in purification operations are desired. 30% effort will be allocated in DSP.
Virus production experience is strongly desired.
Ability to critically analyze data using statistical tools and to compile technical reports.
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.
Some detailed understanding of FDA and EMA regulatory requirements associated with process validation and viral clearance for biologic products.
Strong oral and written communication skills. Ability to influence cross-functionally in a matrix environment.
Proficient in Biocommander, JMP, Excel, PowerPoint and Word applications.
Ability to accomplish projects by deadline in a dynamic environment.
Based in the Company’s North Cambridge office.
Email a cover letter and a copy of your CV to HR@aurabiosciences.com referencing the position description in the subject line.