**About Raycaster**\ We build AI agents for life sciences. Backed by leading life sciences investors and YC, we’re already working with Agilent, Yokogawa Life Sciences and many leading companies to automate their regulated, complex processes to accelerate drug development. \ \ **The role (what you’ll do)** * Partner with CMC teams to **map current workflows** end-to-end (inputs, systems, approvals, artifacts). * Decompose tech-transfer packages (method revs, redlines/rationales, representative chromatograms, acceptance tests) into steps an AI can execute with citations. * Capture **validation/stability/release** processes (accuracy/precision/linearity/LOQ, OOT rules, spec checks, CoAs) and translate them into checklists, schemas, and templates. * Define **data and document requirements** (e.g., LIMS/CDS exports, S3/SharePoint/Vault locations), edge cases, and “fail-closed” rules (no source → no claim). * Review AI-generated drafts for **scientific correctness and compliance expectations** (21 CFR Part 11). * Create clear SOPs/playbooks for each automated workflow; iterate with engineers to reach “ready for pilot” quality. **You might be a fit if you have** * 3 years in **CMC/Analytical Development or QC**, ideally touching **Phase 2/3** or tech transfer to CRO/CMO/CDMO. * Hands-on with **HPLC/LC-MS** (Ion-Pair, HILIC, AEX), method/SOP authoring, and interpreting system-suitability & chromatograms. * Built or reviewed **validation packets** (ICH Q2(R1/R2)), **stability** trending/OOT, **release specs/CoAs**, and **change control** narratives. * Operated in **non-GMP → GMP** handoffs; practical understanding of **21 CFR Part 11** expectations (audit trail, e-sig routing, data integrity). * Familiarity with at least some of: **Veeva Vault** (or MasterControl), **ELN/LIMS** (Benchling, LabWare, SampleManager), **CDS** (Empower/Chromeleon), **Jira/ServiceNow**. * Comfort collaborating with engineers; you enjoy turning tacit know-how into **templates, schemas, and acceptance criteria**. **Nice to have** * ASO, mRNA/LNP, peptides, or oligo experience; Phase 3/registration exposure. * Awareness of CSV (computerized system validation), ALCOA+, and doc control practices. * Light data skills (reading CSVs, understanding units/columns) and curiosity about AWS/S3/Athena-style data lakes. **Why this is interesting**\ You’ll help design the cutting edge of **audited AI workflows** that save teams hours per artifact while keeping reviewers in control.
Your fingerprints will be on how modern CMC gets done.
Job details are sourced from the employer's original posting.
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