(Sr) Associate Scientist, Upstream Process Development

Job Description

Job DescriptionSalary:

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, visitaurabiosciences.com. Follow us on X (formerly Twitter) @AuraBiosciences and visit us on LinkedIn.

Position Summary:

Reporting to the Upstream Process Development Lead, the Associate Scientist/Senior 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 Associate Scientist/Senior Associate 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 on seed train, bioreactor production, as well as primary recovery, utilizing multiple approaches including statistically designed experiments (DoE).
• Design and coordinate scale-down process verification studies.
• Design and support process optimization studies.
• Coordinate and carry out in-house production of representative materials for development use.
• Develop the companys pipeline by supporting process development of new target indications.
• Document studies/lab work in lab notebooks, study plans and reports per company requirements to ensure data integrity and traceability.
• Stay compliant with lab safety regulations and build good lab practice in everyday lab operations.

Technology Development and Continuous Improvement:

• Apply and verify novel manufacturing technologies to Auras unique product.
• Improve process performance and quality of product.
• Contribute to continuous improvement of the internal data management system.

Tech Transfer and PPQ:

• Support implementation of new process technologies or significant changes to processes, equipment, or manufacturing instructions as needed.
• Support tech transfer tasks and support PPQ-enabling activities such as process risk assessment, process characterization and process control strategy development.
• Support evaluation of scale up performance and recommend action items to improve scalability, in collaboration with a cross-functional team.

Manufacturing Support:

• Generate and implement continuous improvement ideas to improve documentation and business practices.
• Support manufacturing by providing technical expertise in the manufacturing area and providing timely support for manufacturing investigations using experiments in Process Development.
• Other projects as assigned by management.

Minimum Requirements:

• Degree in biochemical engineering, biological sciences, biochemistry or related discipline.
• B.S. with 2-4 (or M.S. with 0-2) 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.
• Motivation in performing and learning novel process methods, and good work ethic is critical. Inventory management experience to ensure material supply for upstream process development

Desired Qualifications

• Experience with DoE using JMP or similar system is highly desired.
• Solid understanding of the Quality-by-Design principle and a track record of implementing it in late-stage development (process FMEA, scale-down model qualification and process characterization) is a strong plus.
• Virus production experience is strongly desired.
• Cell culture experience with Mammalian, Insect, CHO, or Yeast cell lines for biologics production are highly desired.
• Experience working with 1L, 10L, and 50L bioreactors is highly desired.
• Experience with optimizing process parameters and supplementation to increase product yield and stability (such as transfection parameters) is strongly desired.
• Occasional effort may be needed in downstream purification. Any chromatography (AKTA systems) and filtration experience are a plus.
• Experience with various analytical procedures is a plus (SDS-PAGE, western blot, ELISA, HPLC, etc.)
• An understanding of current good manufacturing practices (cGMPs) as they apply to the development and qualification of biological manufacturing processes.
• Proficient in Excel, PowerPoint, and Word applications.

Salary & Benefit Information:

Salary Range: $60,000/yr - $115,000/yr

(Placement within the listed range depends on many factors including, but not limited to: geographic location, degree, years of experience, and internal company equity)

Health insurance with FULL premium coverage

401K with company match

Employee Stock Purchase Program (ESPP)

Competitive paid time off (PTO)

Company-paid short & long-term disability insurance and life insurance