This position is no longer available
CMC Workflow Specialist (Analytical/Tech Transfer)
remote•New York•$83k - $270k
Summary
Location
New York
Salary
$83k - $270k
Workplace
Remote
Experience
3+ years
Visa
US citizenship/visa not required
Company links
This position is no longer available
This job listing has been removed by the employer and is no longer accepting applications.
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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.
Technology
AI agents Evals File systems MCP Computer use
Interview Process
Take-home assignment (30 min) to assess existing expert knowledge.
Workflow deep-dive (30 min): You walk us through a real late-stage workflow you know cold (e.g., tech transfer pack or validation summary). We map inputs → outputs → approvals and capture edge cases.
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.
About Raycaster
About RaycasterWe 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.
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Frequently Asked Questions
What does Raycaster pay for a CMC Workflow Specialist (Analytical/Tech Transfer)?
Raycaster offers a competitive compensation package for the CMC Workflow Specialist (Analytical/Tech Transfer) role. The salary range is USD 83k - 270k per year. Apply through Clera to learn more about the full compensation details.
What does a CMC Workflow Specialist (Analytical/Tech Transfer) do at Raycaster?
As a CMC Workflow Specialist (Analytical/Tech Transfer) at Raycaster, you will: 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.; and more.
Is the CMC Workflow Specialist (Analytical/Tech Transfer) position at Raycaster remote?
Yes! The CMC Workflow Specialist (Analytical/Tech Transfer) position at Raycaster is a remote role, with team members based in New York, United States. Apply through Clera to learn more about their remote work policies.
How do I apply for the CMC Workflow Specialist (Analytical/Tech Transfer) position at Raycaster?
You can apply for the CMC Workflow Specialist (Analytical/Tech Transfer) position at Raycasterdirectly through Clera. Click the "Apply Now" button above to start your application. Clera's AI-powered platform will help match your profile with this opportunity and guide you through the application process.