Senior Scientist - Manufacturing Development
ABOUT THE ROLE:
Our Manufacturing Development team’s mission is to develop, de-risk, scale, and continuously improve robust manufacturing processes that enable reliable delivery of the nELISA platform. The team operates at the intersection of engineering, assay development, automation, QC, and operations, with a focus on translating scientific and technical workflows into scalable, reproducible, and manufacturing-ready processes.
As a Senior Scientist, Manufacturing Development, you will provide technical leadership to define, develop and enhance the processes that drive our platform’s scalability and performance. Based at our Montréal, QC facility, this role blends deep scientific and engineering expertise with hands‑on bench work, cross‑functional collaboration and data‑driven planning. You’ll spearhead complex initiatives to improve assay performance, process robustness, throughput, reliability and the smooth transfer of workflows into routine operations.
- Drive complex manufacturing‑development initiatives and help define the technical roadmap — covering process robustness, assay performance, automation readiness, kit manufacturing, QC architecture, scalability, and transfer readiness.
- Convert ambiguous manufacturing or assay requirements into structured experimental and validation plans, and design/run campaigns using DoE, process characterization, robustness testing, FMEA and scale‑up/down approaches.
- Design and develop robust QC strategies (in‑process controls, lot‑to‑lot consistency, trend analysis and pass/fail decision frameworks) and lead cross‑functional root‑cause investigations.
- Deliver stellar communication and collaboration across R&D, Operations, Automation, Quality teams; maintain meticulous documentation and share data‑driven reports, insights and memos to align stakeholders and ensure development outputs are both scientifically sound and operationally ready for transfer.
- Independently analyze and interpret complex datasets...