We are seeking a highly motivated Senior Bioprocess Engineer I/II to join Operations, Science and Technology group. The Engineer will work in a dynamic and diverse team environment to support technology transfer, process scale up and continuous improvement of fermentation and recovery processes used in active pharmaceutical ingredient (API) manufacturing. The engineer will apply scientific, engineering principles and statistical process design/analysis to develop robust upstream fermentation and recovery process. The candidate must have in-depth knowledge and experience including but not limited to fermentation process scale up, primary recovery, process characterization and optimization, scale down model qualifications and validation. Excellent communication skills and the ability to work within a multi-disciplinary and cross-functional teamwork environment are essential.
- Leads the evaluation and development of innovative technologies within the field of downstream recovery processing to improve process efficiency, robustness and product quality
- Performs the scaling up of successful lab studies to pilot scale and subsequently to manufacturing scale qualification, validation and implementation.
- Provides technical support to late clinical stage and commercial API manufacturing processes.
- Provides timely on floor support and troubleshooting experiences in pilot and manufacturing facilities
- Evaluate process fit and equipment compatibility along with process workflow modelling and scheduling.
- Responsible for 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
- Utilizes knowledge of biology, engineering, and statistics to design fermentation scale-down model.
- Perform risk assessment to identify critical control strategies for successful process scale-up and high reproducibility.
- Bachelor’s Degree or equivalent education and typically minimum 10 years of experience,
- Master’s Degree or equivalent education and typically minimum 8 years of experience,
- PhD and typically minimum 3 years of experience.
- Hands-on experience with downstream recovery operations including UF/DF, filtration, and centrifugation.
- Experience in process modelling using SuperPro Designer is preferred.
- Experience with pilot/ commercial fermentation scale up, optimization and operations is desired.
- Familiar with microbiology and biochemical principles, fermentation/recovery process scale-up and statistical methods.
- Demonstrated strong data interpretation and problem-solving skills, and capability to overcome complex issues.
- Demonstrate a high level of scientific initiative in generating and implementing new ideas that are applicable for process improvement and/or troubleshooting.
- Must have the ability to work in teams, communicate technical concepts clearly and be independently motivated.
Significant Work Activities: N/A
Travel: Yes, 10 % of the Time
Job Type: Experienced