Associate Scientist, Upstream Process Development

The Associate Scientist is responsible for designing, planning, and executing experiments to develop and characterize suspension cell culture manufacturing processes. In addition, the individual will support new technology evaluation and development, technology transfer, process characterization and maintenance of lab instruments/infrastructure. These activities will support the cGMP manufacturing operations and production of pre-clinical and clinical material.

Responsibilities:

• Conduct experiments supporting the development of AAV and LVV production processes.

• Analyze and interpret data to draw conclusions and recommend options for future experiments in alignment with achieving project goals.

• Appropriately document experimental procedures and results according to established guidelines.

• Produce pre-clinical material following defined processes in batch record.

• Support technology transfer of new products and processes to ensure smooth transition from process development into cGMP manufacturing.

• Look for opportunities to implement operational excellence and continuous improvement.

• Assist the GMP manufacturing team to resolve any issues related to manufacturing.

• Adhere to all HSE policies, procedures, and guidelines.

Minimum Requirements:

Education: • Minimum B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.

Skills and Experience: • Preferred: 2-4 years of experience in biologics process development or GMP manufacturing operations with direct experience in aseptic technique and upstream cell culture • Experienced in bioreactor operation, including ambr (15 & 250), bench-top, and pilot scales. • Proficient in statistical analysis principles and software. Working knowledge and experience with Design of Experiments (DoE). • Knowledge of gene therapy viral vector production and previous experience with AAV & LVV process development is preferred.

510-347-8904