Our client is looking for an energetic and talented Engineer I, to join the Upstream Process Development group within the Protein Development and CMC team.
This is an exciting opportunity to join an outstanding team with a mission to establish a new bacterial fermentation development lab and pilot plant.
The successful candidate will have the following skills and qualities: · Hands-on experience operating and maintaining bioreactors, including Ambr® 250, at laboratory scale. · Experience in pilot scale fermentation and recovery equipment startup and commissioning · Skillful in analyzing and presenting data for process improvements, troubleshooting, and optimization · An exceptional team player who works seamlessly with others, speaks up, and remains focused on achieving the best results to achieve company goals. · Strong organizational and planning skills.
Essential Functions:
- Lead operational activities related to bioreactor set-up, monitoring, harvest, and maintenance.
- Develop, test, and implement recipe scripting for fed-batch fermentation feeding controls.
- Provide engineering support for selection, commissioning, and qualification of new equipment as well as scale-down models.
- Author SOPs (standard operating procedure), process flow diagrams and batch records.
- Analyze and present fermentation data at internal project meetings. Participate in upstream database management and documentation in electronic notebooks.
Requirements:
- BS in Chemical Engineering or a related discipline with 5+ years of relevant Pharma/Biotech industry experience, or MS with 3+ years of relevant Pharma/Biotech industry experience
- Hands-on experience with fermentation and/or primary recovery unit operations.
- Good understanding in fundamentals of bioreactor design, operation and controls.
- Strong knowledge of aseptic techniques
- Mechanical and technical knowledge of primary recovery unit operations such as homogenization, centrifugation, and depth filtration, is a plus.
- Familiarity with DoE (Design of Experiments) principles and software.
- Familiarity with regulatory requirements of biotherapeutics. Late-stage process characterization experience is a plus.
- All employees require vaccination against COVID-19.