- The candidate will work in a dynamic and diverse team environment to support technology transfer, process scale up and continuous improvement of fermentation processes used in active pharmaceutical ingredient (API) manufacturing.
- Provide technical support (product and process expertise) of manufacturing operations for fermentation processes. This includes a range of activities, from day-to-day manufacturing problem solving, managing productivity targets and maintain quality/regulatory compliance.
- Responsibilities include the design, execution of experiments to develop new fermentation process, develop robust lab/pilot scale processes, support scale-up fermentation and transfer of unit operations into manufacturing sites
- Author or participate in risk assessments and process validation.
- Provide technical expertise to support regulatory submissions.
- Interaction with Manufacturing, Quality, and CMC/Regulatory Affairs groups.
- Chemical Engineering, Biochemical Engineering, Biochemistry or related fields
- Bachelor’s Degree or equivalent education and typically 3-5 years of experience, Master or PhD with 0-3 years
Essential Skills & Abilities
- Experience with industrial scale fermentation scale up, optimization and operations are highly desired
- Experience in designing lab scale microbial fermentation formats and scale-up to pilot/manufacturing scale.
- The candidate should have proven leadership experience and may be required to lead technical projects.
- The candidate should demonstrate a high level of scientific initiative in generating and implementing new ideas that are applicable for process improvement and/or troubleshooting.
- A good understanding of microbiology and biochemical principles, fermentation process scale-up and statistical methods is essential.
- Must have the ability to work in teams, communicate technical concepts clearly and be independently motivated. Additionally, scientific independent thinking and the ability to design/interpret experiments are critical.
- The candidate should be capable both in the lab and in a GMP manufacturing environment.