Analytical Development Lead
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About Nümi
Nümi is a bioproduction platform harnessing human mammary cells to produce key ingredients with proven health benefits across all stages of life. More specifically, it is the first European cultivated breast milk company aiming to produce human milk constituents to better match the ideal nutrition for babies but also improve healthy aging. We are an early-stage, VC-backed biotech based in the heart of Paris (Hôpital Cochin, Paris 14th) and supported by world-class investors and scientific partners.
Nümi's Values
At Nümi, we cultivate positivity every day. Our mission drives us to communicate with passion and energy, always keeping the bigger impact in sight. We celebrate quick wins, but never lose track of our ultimate goal.
Positivity
At Nümi, we cultivate positivity every day. Our mission drives us to communicate with passion and energy, always keeping the bigger impact in sight. We celebrate quick wins, but never lose track of our ultimate goal.
Excellence
At Nümi, excellence starts with dedication and a commitment to constant improvement. We embrace challenges as opportunities to learn and push ourselves to deliver high-quality results. Through effort, attention to detail, and integrity, we grow both individually and collectively as a team.
Team-Work and Pedagogy
At Nümi, we believe that teamwork makes us stronger. We encourage knowledge-sharing, open feedback, and mutual respect. Each Nümiz is here to lift others up, ensuring that the collective succeeds.
Ambition
At Nümi, we set ambitious goals and challenge ourselves to think big. Nümi is driven by bold ideas and relentless determination, always aiming for the stars to create real impact.
Why this role matters
As Nümi scales its ingredient portfolio (bioactive proteins such as lactoferrin, human milk oligosaccharides, functional lipids) from bench to pilot and first regulatory batches, we are looking for an Analytical Development Lead to characterise our ingredients in depth and build the analytical methods that measure them. You will define what we measure, how we measure it and how reliable each result is, for every ingredient we produce.
Reporting to our CTO Eugènie, you will work hand in hand with our Process Development team (upstream and downstream), our Reg & QC Implementation Lead and our Preclinical & Bioactivity Lead. Your data will drive process decisions and feed our regulatory dossiers.
This is a role for an analytical scientist with solid hands-on experience characterising complex ingredients (proteins, oligosaccharides or lipids) and developing methods for them, who now wants to build the analytical platform of a first-of-its-kind product category.
Key Responsibilities
Ingredient Characterisation
- Define and deliver Nümi's analytical strategy across the ingredient portfolio, from R&D samples to pilot and regulatory batches
- Build the full characterisation package of each ingredient: identity and structure, purity, composition, isoforms and post-translational modifications for proteins, oligosaccharide and lipid profiles
- Benchmark our ingredients against their human milk counterparts and marketed references in terms of structure and sequences
- Characterise the process-related impurities specific to a cell culture process: host cell proteins, residual DNA, media components
Method Development and Validation
- Develop, optimise and qualify fit-for-purpose analytical methods for each ingredient (LC-MS, HPLC/UPLC, HPAEC-PAD, electrophoresis, immunoassays), and validate them following ICH Q2 principles
- Decide what to build in-house and what to run with external labs, and transfer methods to QC or partner labs
- Set up reference standards, system suitability criteria and method documentation (SOPs, validation reports)
Process Support, Specifications and Stability
- Provide fast, reliable in-process and release analytics to the upstream and downstream teams, so every process decision rests on solid data
- Propose release specifications and certificates of analysis for each ingredient
- Design and run stability studies, and batch-to-batch and scale comparability studies
Cross-Functional Collaboration
- Provide the analytical data, method descriptions and test material characterisation that our Reg & QC Implementation Lead and external partners need for regulatory dossiers and safety studies
- Manage external analytical labs: scoping, follow-up and critical review of results
- Partner with our Data team so every analytical result lands in a structured, queryable dataset
Innovation and Digital Tools
- Evaluate and integrate new analytical technologies and AI-enabled tools that speed up data analysis and reporting<