About Aura :
Aura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors that aim to preserve organ function. Our lead candidate, bel-sar (AU-011), is currently in late-stage development for primary choroidal melanoma and in early-stage development in other ocular oncology indications and bladder cancer. Aura Biosciences is headquartered in Boston, MA. Our mission is to grow as an innovative global oncology company that positively transforms the lives of patients.
For more information, visit aurabiosciences.com. Follow us on X (formerly Twitter) @AuraBiosciences and visit us on LinkedIn.

POSITION SUMMARY:

Reporting to the lead of Downstream Process Development, this person will develop and transfer processes to support biopharmaceutical product development at Contract Manufacturing Organizations (CMOs). This individual will also support process development, characterization, and validation activities both internally and at CMOs. The associate scientist will interact with the in-house team including process development and external manufacturing as well as CRO/CMO to ensure timely progress in technology development, documentation, and manufacturing readiness.

MINIMUM REQUIREMENTS:

• Degree in biochemical engineering, chemical engineering, biology, biochemistry, or related discipline.
• S. and 0-2 years of experience in pharmaceutical, biologics, viral production, or a related field.
• Motivated to learn and implement novel process methods, and good work ethic is critical.
• Understanding of biologics manufacturing is preferred in multiple areas including cell culture (small and large scale), 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.Strong oral and written communication skills. Ability to influence cross-functionally in a matrix environment.

DESIRED QUALIFICATIONS:

• Experience with AKTA Pure or Avant or Pilot system is preferred.
• Virus production experience is preferred.
• Experience with analytic instruments/techniques including UV/Vis Spectroscopy, HPLC, SDS-Page, Western Blot, DLS, Calorimetry, ELISA, PCR, PicoGreen.
• 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 preferred.
• Proficient in Excel, PowerPoint, and Word applications.Familiarity with Quality by design (QbD), risk assessments, tech transfer, and scale-up work is preferred

Process development:

• Perform liquid chromatography in various modalities on AKTA FPLC.
• Perform tangential flow filtration.
• Troubleshoot process and analytical equipment.
• Perform supporting lab activities such as buffer preparation, column packing, and system sanitization.
• Support design, coordinate, and execute purification process development studies utilizing multiple approaches including statistically designed experiments (DoE).

• Support design and coordinate scale-down process verification studies.Support design and execution of process characterization and optimization studies and material generation runs

Technology Development and Continuous Improvement:

• Support the development, application, and verification of novel processes to Aura’s unique product.

• Apply current and new process technologies to develop robust upstream and downstream manufacturing processes for Aura’s novel VLP based products .Evaluate and improve current manufacturing processes to ensure product quality and improve process performance.

Tech Transfer:

• Collaborate with cross-functional teams including manufacturing, quality, and program management to ensure successful execution of technology transfer project.
• Support implementation of new process technologies or significant changes to processes, equipment, or manufacturing instructions at Aura’s CMOs.

• Identify tasks and activities for tech transfer and process validation.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 internal data for comparison to manufacturing from ongoing manufacturing campaigns

• Author process description and development reports to support tech transfer.Other projects as assigned by management.