Job Title: Process Development & Scale-Up Associate

Work Location: Durham County, North Carolina

Summary:

Seeking a driven individual to support the technical development and scale-up of fermentation and downstream processing, with a focus on transitioning new strains from bench scale to manufacturing. This role offers end-to-end visibility of product development and the opportunity to directly impact technical and operational success across multiple scale-up programs.

Responsibilities:

• Collaborate with external manufacturing partners to develop and optimize processes for scaling novel strains in the probiotics sector.
• Guide projects from proof-of-concept at bench scale through pilot and full manufacturing scales, ensuring smooth technical transfer.
• Conduct research and contribute to process development that aligns with commercialization cost targets for new technologies.
• Organize and maintain comprehensive data records for all process development activities, both internally and with partners.
• Monitor project timelines and ensure milestones and deadlines are consistently met.
• Travel to third-party facilities (approximately 25% of the time) to support development and commercialization efforts.
• Troubleshoot and resolve issues related to technology scale-up and process optimization.
• Assist in downstream applications, including product formulation, stability, shelf life, and contribute to the development of freeze drying, spray drying, and cryopreservation processes.

Qualifications:

• Bachelor's degree or higher in a relevant field such as life sciences or engineering.
• 2–5 years of experience in industrial fermentation, biotechnology, or downstream processing.
• Experience preparing technical transfer documents and supporting scale-up activities.
• Familiarity with live probiotic strains is preferred.
• Experience working with anaerobic strains is preferred.

Published Category: Analytical & Process Development, Supply Chain & CMC