About the Role
We are developing an enterprise bioprocess intelligence platform designed to serve the full lifecycle of biopharmaceutical manufacturing—from high-throughput lab screening and process development (PD) to pilot scale-up, tech transfer, and commercial-scale manufacturing. Our initial target partners include tier-1 pharma and global CDMOs.
We are looking for a Principal Bioprocess Subject Matter Expert with broad, end-to-end expertise spanning benchtop development through commercial manufacturing scale. In this role, your core responsibility is product validation, scenario modeling, edge-case definition, and domain troubleshooting across the entire scale spectrum.
You will guide our engineering team by providing authentic operational scenarios, catching scaling physics/kinetics inaccuracies, and pressure-testing how the platform handles data from bench reactors up to 2,000L–20,000L production vessels.
Key Responsibilities
End-to-End Scale Scenario Modeling: Provide authentic datasets, run parameters, and test scenarios across the entire lifecycle:
Lab Scale:
High-throughput screening and DoE optimization (e.g., Ambr 15/250, benchtop glass vessels).
Pilot & Scale-Up: Seed train expansion, hydrodynamic scaling parameters ($k_La$, tip speed, power input per unit volume $P/V$, mixing time).
Commercial Production: Large-scale single-use and stainless steel bioreactors (2,000 L –20,000L), batch records, and harvest interfaces.
Guide Tech Transfer & Scale-Down Models: Advise engineering on how scaling discrepancies occur in real life (e.g., mass transfer limitations, CO2 stripping challenges, shear stress, temperature/pH gradient heterogeneity in large tanks) and how validated scale-down models are structured.
Pressure-Test Failure Modes & Deviations: Define realistic operational disruptions for platform validation, such as:
Sensor calibration drift vs. true biological drift.
Inoculum quality variations and seed train delays.
Gas sparging bottlenecks and oxygen
📌 Principal Bioprocess SME (India)
🏢 OpenAna
📍 India