Senior Scientist, Technology Transfer & CDMO Operations

Scorpion Therapeutics; San Diego (CA); On-site; USD 170,000 - 230,000; Full time

Benefits offered by this job

Health coverage

Wellbeing programs

401(k)

Disability insurance

Life insurance

Paid time off

Job summary

Scorpion Therapeutics in San Diego, CA, seeks a senior professional to lead end-to-end technology transfer and CDMO relationship management for radiopharmaceutical drug products. You will function as the primary operational/technical liaison between internal teams and external CDMOs, overseeing the full CDMO lifecycle from selection and onboarding through clinical supply chain management.

The role requires 5+ years in tech transfer/CMC/manufacturing within pharma/biopharma, with experience

Qualifications

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

Responsibilities

• Lead end-to-end technology transfer and CDMO relationship management.
• Own technology transfer from development to CDMOs with plans, timelines, success criteria.
• Manage day-to-day CDMO relationships; resolve technical/operational issues; ensure quality and delivery.
• Oversee clinical supply chain (material flow, inventory, logistics, coordination).
• Partner cross-functionally with Regulatory, Quality, Clinical; communicate risks/status.
• Lead agreements and documents (CDAs, Quality Agreements, Technical Packages, SOWs).
• Develop technical transfer packages (process descriptions, batch records, analytical methods).
• Support IND/CMC and quality activities (audits, CAPAs, gap assessments).
• Maintain oversight through Phase 1+ (batch record reviews, deviations, change control).
• Support vendor qualification/RFP and due diligence; manage multiple projects.

Skills

CMC principles

GMP manufacturing

Analytical method transfer

Quality systems

CDMO/vendor management

Clinical supply chain

Regulatory awareness

Project management

Cross-functional collaboration

Education

BSc in relevant scientific/engineering field

MSc in relevant field

PhD in relevant field

Job description

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.

Responsibilities

• 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%.

Education/Experience

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

Preferred Qualifications

• 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.

Skills/Qualifications

• 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.

Benefits (if applicable)

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