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Raycaster · 4 months ago

CMC Workflow Specialist (Analytical/Tech Transfer)

New York, NY

Contract

Hybrid

Mid Level

3+ years exp

Raycaster is an innovative company that builds AI agents for life sciences, collaborating with major industry players to enhance drug development processes. The CMC Workflow Specialist will partner with CMC teams to optimize workflows and translate complex processes into automated systems, ensuring compliance and scientific accuracy.

Artificial Intelligence (AI)BiotechnologyGenerative AISalesSoftware

Responsibilities

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

Qualification

CMC/Analytical DevelopmentHPLC/LC-MS21 CFR Part 11Validation packetsVeeva VaultELN/LIMSCollaboration with engineersSOPs/playbooks authoringData skills

Required

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