Open Ana
Website:
openana.ai
Job details:
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 enrichment limitations at scale.
- Raw material lot-to-lot variability (media/feed composition shifts).
- Validate Critical Quality & Process Linkages: Ensure the platform accurately models the relationship between upstream Critical Process Parameters (CPPs) and product Critical Quality Attributes (CQAs) through harvest and primary downstream capture.
- Review Regulatory & Manufacturing Logic: Validate that workflows reflect commercial biopharma compliance frameworks, including Quality by Design (QbD), Continued Process Verification (CPV), Process Performance Qualification (PPQ), and GxP/21 CFR Part 11 requirements.
- Enterprise Customer Alignment: Support technical discovery and pilot evaluations with Heads of Process Development, MSAT Directors, and Plant Operations Leads at target pharma and CDMO partners.
Required Qualifications
- Education: Advanced degree (M.S. or Ph.D.) in Biochemical Engineering, Chemical Engineering, Biotechnology, or a closely related discipline.
- End-to-End Experience: 8+ years of hands-on experience spanning Upstream Process Development (PD), MSAT (Manufacturing Science & Technology), or Late-Stage Scale-Up / Commercial Operations in biopharma or CDMO environments.
- Deep Scale Fluency: Direct working familiarity with scale transition mechanics—translating processes from micro/bench scale through pilot to commercial scale single-use or stainless steel.
- Broad Modality Knowledge: Strong foundation in Mammalian Cell Culture (CHO / mAbs / Recombinant Proteins), with working exposure to microbial fermentation or viral vector platforms.
- Industrial Hardware & Automation Exposure: Understanding of both bench equipment and plant-floor automation/historian systems (e.g., DeltaV, OSIsoft PI / AVEVA, Sartorius/Cytiva bioreactor platforms).
- Root-Cause Analysis Acumen: Deep experience leading out-of-spec (OOS) investigations, deviation assessments, and process characterization studies.
Preferred Qualifications
- Prior direct career experience at top biomanufacturers or CDMOs
- Exposure to Tech Transfer packages, Process Validation (Stage 1, 2, 3 CPV), and regulatory filing documentation (IND/BLA CMC).
- Familiarity with Process Analytical Technology (PAT) deployments at pilot or commercial scale (e.g., in-line Raman, off-gas mass spectrometry).
Click on Apply to know more.
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