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 by combining assay performance, process parameters, QC trends and operational metrics, and translate into actionable technical recommendations and continuous‑improvement initiatives that enhance reproducibility, stability, throughput and compliance.

• Mentor scientists and associates, providing technical guidance on experimental design, troubleshooting, data interpretation, automation‑aware process development, QC thinking and kit‑manufacturing best practices.

• PhD or Master’s in bioengineering, biotechnology, biochemistry or a related field with at least five years of industry experience working in wet‑lab environments.

• Deep expertise in protein quantification and immunoassay methods (ELISA, sandwich assays, flow cytometry, bead‑based assays), kit development, QC under GMP/GLP standards, and a strong foundation in genomics, transcriptomics and proteomics technologies.

• Proven ability to design, lead and scale complex experiments and process development projects (e.g. assay optimization, process characterization, robustness and validation studies), including tech transfer and compliance to regulated environments.

• Hands‑on experience with automation‑enabled workflows and instrumentation (liquid handlers, plate readers, washers, dispensers, imaging systems), coupled with strong data analysis (Python or equivalent) and scientific judgement to translate complex assay behaviour into practical, scalable and controlled workflows.

• Demonstrated leadership in mentoring and developing junior scientists, and comfort operating in fast‑paced, evolving environments where scientific ambiguity, operational constraints and scaling needs must be balanced thoughtfully.

• Strong English communication skills for collaborating with U.S.‑based teams, partners and vendors.

• Connect deeply with our mission, ambition and sense of duty. Our mission isn’t marketing flash: we developed our technology to better measure biology and discover biomarkers for early disease detection. We firmly believe we will be successful in literally eradicating certain diseases by enabling them to be diagnosed earlier. We also believe that our hard work to bring this technology to its…