{"id":344652,"url":"https://alion.io/job/raycaster-cmc-workflow-specialist-analyticaltech-transfer","title":"CMC Workflow Specialist (Analytical/Tech Transfer)","company":{"id":3107,"name":"Raycaster","domain":"raycaster.ai","url":"https://alion.io/company/raycaster","size_band":"11-50","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Work at a Startup","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"middle","employment_type":"contractor","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["New York, United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":40,"max":130,"currency":"USD","period":"hour","gross":null,"usd_annual":260000},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"AI Agents","optional":false},{"name":"Amazon S3","optional":false},{"name":"Benchling","optional":false},{"name":"GMP","optional":false},{"name":"HPLC","optional":false},{"name":"ICH Guidelines","optional":false},{"name":"Jira","optional":false},{"name":"LIMS","optional":false},{"name":"Mass Spectrometry","optional":false},{"name":"ServiceNow","optional":false},{"name":"SharePoint","optional":false},{"name":"Veeva","optional":false},{"name":"AWS","optional":true}],"status":"live","first_seen_at":"2026-09-05T18:24:55Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-30T10:11:55Z","board_verified":true,"closed_at":null,"days_open":54,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":54},"description":"About Raycaster\nWe 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.\nThe role (what you’ll do)\nPartner with CMC teams to map current workflows end-to-end (inputs, systems, approvals, artifacts).\nDecompose tech-transfer packages (method revs, redlines/rationales, representative chromatograms, acceptance tests) into steps an AI can execute with citations.\nCapture validation/stability/release processes (accuracy/precision/linearity/LOQ, OOT rules, spec checks, CoAs) and translate them into checklists, schemas, and templates.\nDefine data and document requirements (e.g., LIMS/CDS exports, S3/SharePoint/Vault locations), edge cases, and “fail-closed” rules (no source → no claim).\nReview AI-generated drafts for scientific correctness and compliance expectations (21 CFR Part 11).\nCreate clear SOPs/playbooks for each automated workflow; iterate with engineers to reach “ready for pilot” quality.\nYou might be a fit if you have\n3 years in CMC/Analytical Development or QC, ideally touching Phase 2/3 or tech transfer to CRO/CMO/CDMO.\nHands-on with HPLC/LC-MS (Ion-Pair, HILIC, AEX), method/SOP authoring, and interpreting system-suitability & chromatograms.\nBuilt or reviewed validation packets (ICH Q2(R1/R2)), stability trending/OOT, release specs/CoAs, and change control narratives.\nOperated in non-GMP → GMP handoffs; practical understanding of 21 CFR Part 11 expectations (audit trail, e-sig routing, data integrity).\nFamiliarity with at least some of: Veeva Vault (or MasterControl), ELN/LIMS (Benchling, LabWare, SampleManager), CDS (Empower/Chromeleon), Jira/ServiceNow.\nComfort collaborating with engineers; you enjoy turning tacit know-how into templates, schemas, and acceptance criteria.\nNice to have\nASO, mRNA/LNP, peptides, or oligo experience; Phase 3/registration exposure.\nAwareness of CSV (computerized system validation), ALCOA+, and doc control practices.\nLight data skills (reading CSVs, understanding units/columns) and curiosity about AWS/S3/Athena-style data lakes.\nWhy this is interesting\nYou’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.\nTake-home assignment (30 min) to assess existing expert knowledge.\nWorkflow 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.\nOffer","description_format":"text","description_chars":2675,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Machine Learning","AI Training Data & Annotation"],"lifecycle":[{"event":"open","at":"2026-09-05T18:24:55Z"}],"visa":[],"liveness":{"score":11,"band":"cold","label":"Long shot","p_open":1,"p_active":0.303,"p_room":0.35,"age_days":54,"expected_fill_days":7,"reasons":["conf:0","win:tail"],"computed_at":"2026-10-30T05:48:23Z"},"pay":{"stated_usd_annual":260000,"is_top_pay":true},"html_url":"https://alion.io/job/raycaster-cmc-workflow-specialist-analyticaltech-transfer","json_url":"https://alion.io/job/raycaster-cmc-workflow-specialist-analyticaltech-transfer.json","meta":{"generated_at":"2026-10-30T10:17:00Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":14791,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-31T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":3107},"rest":"https://alion.io/mcp/rest/get_company?id=3107"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fraycaster-cmc-workflow-specialist-analyticaltech-transfer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fraycaster-cmc-workflow-specialist-analyticaltech-transfer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fraycaster-cmc-workflow-specialist-analyticaltech-transfer"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/raycaster-cmc-workflow-specialist-analyticaltech-transfer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fraycaster-cmc-workflow-specialist-analyticaltech-transfer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":344652}},{"tool":"search_jobs","arguments":{"company":"raycaster.ai","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":344652},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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