Principal Scientist

Main responsibilities

• Lead scale-up activities from bench scale to pilot scale (200L2000L), applying engineering principles (mixing, mass transfer, shear stress, dissolved oxygen control) to ensure process comparability at large scale.
• Collaborate with process development scientists to translate laboratory findings into scalable, robust manufacturing processes.
• Review and approve JSAs written by equipment owners and provide feedback.
• Train employees to adopt best practice for safety, efficiency and operational success.
• Build robust internal interfaces with the CMC community and promote the adoption of best practices.
• Demonstrate expertise in upstream process operations at all scales.
• Lead root cause analysis (RCA) investigations for process deviations, equipment failures at pilot scale.
• Present findings and/or results to senior management, external stakeholders, and industry leaders at national/international conferences.

About You

• Masters degree in Chemical Engineering, or related discipline with a minimum of 6 years of relevant experience to large-scale bioreactors, or a Ph.D degree with a minimum of 4 years of industry experience related to large-scale bioreactors.
• Strong background in cell culture bioreactor operations and scale-up technologies.
• Experience in the biotech/pharmaceutical industry within a cell culture role and an excellent understanding of the operational excellence.
• Experience with perfusion process operations at various scales.
• Understanding of engineering principles related to cell culture process is required.
• Able to lead matrix teams for operations and lab management.

Preferred Qualifications

• Experience managing cross-functional team and initiatives.
• Experience in cell culture process development for AAV manufacturing.
• Expertise in mammalian cell culture and related aspects such as cell metabolism/media optimization, engineering fundamentals on cell culture scale-up/down, cell biology/physiology.
• Process automation experience.