The candidate will play a significant role in pilot scale operations, process scale-up, manufacturing facility fit, and overall tech transfer from development to drug substance manufacturing site. The ability to manage their work efficiently, apply in depth knowledge of biology and/or engineering principles, maintain operational excellence, meet project timelines and influence other stakeholders across the development organization are all key responsibilities of this position. The candidate will lead the pilot development of continuous manufacturing, high-throughput fed-batch process, and advanced process control technologies.

Responsibilities:

1. Design, develop and execute pilot development experiments

2. Coach and mentor junior team members to ensure pilot batches are well-planned and executed

3. Represent upstream development within cross-functional tech transfer teams

4. Lead new technology evaluations and innovation projects

5. Transfer and implement new technologies to the manufacturing space

6. Perform high-quality data analysis and interpretation

7. Troubleshoot process deviation and optimize scale-up strategies

8. Perform facility fit analysis through monte carlo simulation and other statistical models

9. Document development work in concise reports

10. Provide project updates in written and oral presentations

1. Experience in continuous manufacturing and high-throughput fed-batch process

2. Knowledge in raman spectroscopy, bio-capacitance, off-gas analyzer, refractive index probes, and/or other related advanced process control technologies

3. Familiar with cell culture perfusion process in tangential flow filtration and/or alternative tangential flow filtration

4. Understanding of hydrodynamic/shear stress, mass transfer, power per volume, and scale-up.

5. Strong analytical and mathematical skills (regression model, monte carlo simulation, etc.)

6. Proven record of successfully planning and executing projects and experiments

7. Excellent written and verbal communication skills

8. Strong organizational skills and ability to administer a project in timely manner

9. Highly skilled in Microsoft Word, Excel, Powerpoint, and Project. Familiarity with computational fluid dynamics (ANSYS Fluent), Oracle Crystal Ball, Design Expert (Stat-Ease), JMP, Matlab, Umetrics, and other statistics software is a plus

The candidate will play a significant role in pilot scale operations, process scale-up, manufacturing facility fit, and overall tech transfer from development to drug substance manufacturing site. The ability to manage their work efficiently, apply in depth knowledge of biology and/or engineering principles, maintain operational excellence, meet project timelines and influence other stakeholders across the development organization are all key responsibilities of this position. The candidate will lead the pilot development of continuous manufacturing, high-throughput fed-batch process, and advanced process control technologies.