Senior Scientist, Technology Transfer & CDMO Operations

Summary

• Lead end-to-end technology transfer and CDMO relationship management for radiopharmaceutical drug products, serving as the primary operational/technical liaison between internal teams and external CDMOs. Oversee the full CDMO lifecycle (selection/onboarding through clinical supply chain management) in alignment with Regulatory, Quality, and Clinical teams.

• Own technology transfer from internal development to domestic/international CDMOs (plans, timelines, success criteria).
• Manage day-to-day CDMO relationships; resolve technical/operational issues; ensure quality, compliance, and delivery.
• Oversee clinical supply chain (material flow, inventory, logistics, drug substance/product coordination).
• Partner cross-functionally (Regulatory, Quality, Clinical) and communicate risks/status.
• Lead agreements and documents (CDAs, Quality Agreements, Technical Packages, SOWs, supply agreements).
• Develop technical transfer packages (process descriptions, batch records, analytical methods, specs, CMC documentation).
• Support IND/CMC and quality activities (audits, gap assessments, CAPAs).
• Maintain oversight through Phase 1+ (batch record reviews, deviations, change control, supply planning).
• Support vendor qualification/RFP and due diligence.
• Manage multiple concurrent projects (plans, risk registers, communication cadence).
• Author and maintain program documentation; provide status reporting.
• Travel up to 25–30%.

• BSc +7 years, MSc +5 years, or PhD +2 years in relevant scientific/engineering field with pharma/biopharma industry experience.

• 5+ years direct tech transfer/CMC/manufacturing experience (pharma/biopharma/radiopharma).
• Experience managing CDMOs across multiple geographies (ex-US strongly preferred).
• IND-enabling and Phase 1 clinical manufacturing experience.
• Radiopharmaceutical manufacturing/GMP familiarity.
• Supply chain/clinical logistics experience preferred.

• Working knowledge of CMC principles, GMP manufacturing, analytical method transfers, quality systems.
• CDMO/vendor management; clinical supply chain knowledge (forecasting, logistics, cold chain, import/export considerations).
• Document authoring (Quality Agreements, CDAs, Technical Packages, SOWs, regulatory CMC).
• Strong project management (e.g., MS Project/Smartsheet; PMP a plus).
• Cross-functional collaboration; clear written/verbal communication.
• Regulatory awareness (FDA and international agencies).
• Ethics/confidentiality; proactive problem-solving.

• Health coverage (medical/pharmacy/dental/vision), wellbeing programs, 401(k), disability/life insurance, and paid time off.