← All roles

CMC Workflow Specialist (Analytical/Tech Transfer)

Raycaster· Operations
Apply on company site
Hybrid (New York City, NY)$40/hr - $130/hrContractPosted 11mo ago

About the role

Raycaster is seeking a CMC Workflow Specialist to map analytical development and tech transfer workflows, translate validation and release criteria into actionable SOPs and templates, and ensure scientific accuracy and regulatory compliance in AI-assisted workflows for life sciences.

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.

Qualifications

  • - 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.
  • - Experience with non-GMP → GMP handoffs; practical understanding of 21 CFR Part 11 (audit trails, e-sig routing, data integrity).
  • - Familiarity with Veeva Vault (or MasterControl), ELN/LIMS (Benchling, LabWare, SampleManager), CDS (Empower/Chromeleon), Jira/ServiceNow.
  • - Comfortable collaborating with engineers and turning tacit knowledge into templates, schemas, and acceptance criteria.

Skills

Required:CMC/Analytical DevelopmentHPLC/LC-MSValidation & CPPsRegulatory Compliance
Last updated Sep 23, 2026. Interested? Apply on the company site.
Raycaster logo

About Raycaster

Enterprise AI for life sciences

Raycaster is the enterprise AI engine for life sciences. From speeding up regulatory approval and manufacturing tech transfer, Raycaster advances the Industry 4.0 initiatives with world's leading life sciences companies.

saasbiotechenterprise-softwareai
Company profileWebsite

More open roles at Raycaster