Manager/Senior Manager, Process Development, MSAT
Listed on 2026-09-24
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Research/Development
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Engineering
Process Engineer, Quality Engineering
Manager / Senior Manager,Process Development, MSAT Cirsium Biosciences is an early-stage biotechnology company developing a novel plant-based platform for AAV production. We are advancing our technology from Research through Process Development and toward clinical and manufacturing readiness. Position Summary
Function: Process Development/Technical Operations
Level: Manager or Senior Manager, based on experience
Position: Full-time
Cirsium Biosciences is seeking a hands-on Manager/Senior Manager, Process Development, MSAT & Technology Transfer to provide technical leadership across upstream and downstream process development and help establish the bridge between Research, Process Development, and future manufacturing.
This is a boots-on-the-ground technical leadership role. The successful candidate will work directly with scientists and technical teams and will be actively involved in development activities, troubleshooting, scale-up, process characterization, and technology transfer.
We are looking for someone who understands how early-stage science becomes a controlled, reproducible, scalable, and transferable manufacturing process. This individual must be comfortable operating in a Research and Process Development environment while bringing strong knowledge of GMP, CMC, regulatory expectations, and manufacturing readiness.
The role will support the full process, including upstream production and downstream recovery, purification, and related unit operations. This individual will work cross-functionally to ensure process knowledge is appropriately developed, documented, and transferred as programs progress.
This position offers significant growth potential and the opportunity to help build Cirsium’s Process Development, MSAT, and Technology Transfer capabilities as the organization grows.
AAV or viral vector process development/manufacturing experience is highly desirable.
Key responsibilitiesUpstream & Downstream Process Development
- Provide hands‑on technical leadership and day‑to‑day oversight of upstream and downstream Process Development activities.
- Partner closely with Research to transition promising early-stage processes and technologies into structured Process Development.
- Support development and optimization of upstream production processes and downstream recovery, clarification, purification, and related unit operations.
- Drive process optimization, scale-up, characterization, robustness, reproducibility, and process understanding.
- Guide identification and evaluation of critical process parameters, critical material attributes, process inputs, operating ranges, process controls, and sources of variability.
- Ensure upstream and downstream development strategies are integrated and evaluate the impact of process changes on subsequent unit operations and product quality.
- Partner with Analytical Development to ensure analytical methods and testing strategies support process understanding, characterization, development decisions, and technology transfer.
- Provide hands‑on troubleshooting and technical support during development, scale-up, and engineering activities.
- Identify technical and operational risks early and work cross-functionally to develop practical mitigation strategies.
- Develop and lead a structured approach for transferring processes from Research into Process Development and from Process Development into internal or external manufacturing.
- Assess process readiness prior to technology transfer and identify technical, analytical, equipment, material, documentation, training, facility, and process‑control gaps.
- Develop and maintain technology‑transfer plans, protocols, reports, process descriptions, and technical transfer packages.
- Ensure development history, process parameters, material…
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