AI Biologist - Tx - Biologics Drug Development

**AI Biologist - Tx - Biologics Drug Development**

You will contribute to our technical approach for evaluating how AI agents reason through complex biologics **development and manufacturing** workflows. Working with software engineers and biologists, you'll build ground-truth benchmark datasets, drawn from real antibody and protein development programs, that rigorously test whether agents can interpret critical developability and manufacturability data, predict PK from biophysical properties, assess immunogenicity risk, and make formulation and advancement decisions.

Your hands-on expertise in developability assessment, PK/PD reasoning, and manufacturing-readiness judgment will define how we measure agent capability in translating preclinical antibody candidates into clinical and commercial products.

* **2+ years hands-on experience in biologics development or CMC** (formulation, process development, analytical characterization, or regulatory affairs for monoclonal antibodies or recombinant proteins)
* **Experience interpreting developability and product-quality assays**, including at least 3 of:
* FcRn binding kinetics and serum half-life prediction
* Viscosity, aggregation, and forced-degradation studies
* Charge variant profiling (CEX-HPLC, IEX)
* Immunogenicity risk assessment (ADA, MAPP, cytokine release)
* Effector function assays (ADCC, ADCP, CDC)
* SEC-HPLC, glycosylation analysis, and product quality characterization
* **Proficiency in Python and/or R** for data analysis, visualization, and PK/PD modeling
* **Familiarity with at least one of:**PK/PD modeling for biologics (exposure-response, receptor occupancy, half-life projections, dose-exposure relationships)
* Formulation development (pH, buffer, excipient selection; high-concentration protein stability)
* Process development and CMC strategy (scale-up, purity, impurity characterization)
* Regulatory knowledge (ICH guidance, CMC modules, clinical trial expectations)
* Direct experience with ADA/immunogenicity study design or interpretation
* Hands-on analytical method development (LCMS, SEC-HPLC, CEX optimization)
* GMP/manufacturing oversight or tech-transfer experience
* Exposure to manufacturing constraints and cost-of-goods trade-offs
* Experience bridging preclinical > clinical development decisions

**How we work.** Genuinely flexible schedules - we just ask that you communicate when you're coming in later than usual. We care most about hard work and output. We're respectfully opinionated, it will always be us against problems, not each other. Optimize for each other's time and bring solutions, not just problems. You'll join a bench suited to your expertise, but we value cross-domain learning and interoperability across teams.

**Remote roles available globally. (**W8-BEN) contract, 40 hrs/week, no end date.

**Your Pay.** Yearly earnings range from $100,000 to $180,000 USD / year, depending on your experience and the cost-of-living for your location.