(Sr) Associate Scientist, Upstream Process Development

Aura Biosciences; Boston (MA); On-site; USD 60,000 - 115,000; Full time

Job summary

An innovative biotechnology company is seeking a motivated Associate Scientist to join their Upstream Process Development team. This exciting role involves developing and optimizing production processes for cutting-edge therapies aimed at treating solid tumors. You will collaborate with various teams to ensure the successful transfer of processes to Contract Manufacturing Organizations, all while maintaining high standards of compliance and documentation. This is a fantastic opportunity to contribute to groundbreaking work in oncology and to grow your career in a dynamic, supportive environment.

Benefits

Health Insurance (Full Premium Coverage)

401K with Match

Employee Stock Purchase Program

PTO

Disability Insurance

Life Insurance

Qualifications

• Degree in biochemical engineering or biological sciences required.
• Experience in biologics manufacturing and cell culture development preferred.

Responsibilities

• Develop upstream production processes and produce material for development.
• Support process transfer to Contract Manufacturing Organizations.

Skills

Statistical Analysis

Cell Culture Development

Communication Skills

Process Optimization

Data Management

Education

B.S. in Biochemical Engineering

M.S. in Biological Sciences

Tools

DoE (JMP or similar)

MS Office

Bioreactors (1L, 10L, 50L)

SDS-PAGE

HPLC

Job description

(Sr) Associate Scientist, Upstream Process Development

Join to apply for the (Sr) Associate Scientist, Upstream Process Development role at Aura Biosciences.

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 Upstream Process Development Lead, the Associate Scientist/Senior Associate Scientist will be responsible for developing upstream production processes and producing material for routine in-house development. This includes assays related to cell culture production. The role also involves supporting process transfer to Contract Manufacturing Organizations (CMOs) for biopharmaceutical product development. The incumbent will collaborate with in-house teams and CRO/CMO to ensure timely progress, documentation, and manufacturing readiness.

Process Development Responsibilities

• Design, coordinate, and execute process development studies on seed train, bioreactor production, and primary recovery, utilizing approaches including statistically designed experiments (DoE).
• Design and coordinate scale-down process verification studies.
• Support process optimization studies.
• Coordinate in-house production of materials for development use.
• Support pipeline development by assisting in process development for new indications.
• Document studies and lab work in notebooks, study plans, and reports to ensure data integrity.
• Maintain compliance with lab safety regulations and promote good lab practices.

Technology Development and Continuous Improvement

• Apply and verify novel manufacturing technologies for Aura’s products.
• Enhance process performance and product quality.
• Contribute to improving data management systems.

Tech Transfer and PPQ

• Support implementation of new process technologies and changes.
• Assist with tech transfer tasks and PPQ activities like risk assessment and process characterization.
• Evaluate scale-up performance and recommend improvements.

Manufacturing Support

• Generate ideas for continuous improvement in documentation and practices.
• Provide technical support for manufacturing investigations.
• Perform other projects as assigned.

Minimum Requirements

• Degree in biochemical engineering, biological sciences, biochemistry, or related field.
• B.S. with 2-4 years or M.S. with 0-2 years of relevant experience.
• Understanding of biologics manufacturing, including cell culture development and transfections.
• Ability to analyze data statistically and compile reports.
• Ability to meet project deadlines in a dynamic environment.
• Strong communication skills.
• Motivation to learn new processes and a good work ethic.

Desired Qualifications

• Experience with DoE (JMP or similar).
• Knowledge of Quality-by-Design and process FMEA.
• Virus production experience.
• Cell culture experience with mammalian, insect, CHO, or yeast cells.
• Experience with bioreactors (1L, 10L, 50L).
• Process optimization experience, especially transfection parameters.
• Chromatography and filtration experience.
• Analytical procedures knowledge (SDS-PAGE, Western blot, ELISA, HPLC).
• Understanding of cGMPs in biological manufacturing.
• Proficiency in MS Office applications.

Salary & Benefits

Range: $60,000 - $115,000 per year, depending on factors such as location, degree, experience, and company equity.

Benefits include health insurance (full premium coverage), 401K with match, Employee Stock Purchase Program, PTO, disability and life insurance.

Additional Details

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Research, Analysis, IT