Manager, Technology Transfer & CDMO Operations
Bristol Myers Squibb
4 days ago
Remote friendly (San Diego, CA)
United States
Operations
Summary / Role Responsibilities
- Own end-to-end technology transfer of radiopharmaceutical drug products from internal development to US and international CDMO partners (plans, timelines, success criteria).
- Manage CDMO relationships across the manufacturing lifecycle; track milestones, resolve issues, and ensure quality/compliance/delivery.
- Coordinate clinical supply chain (material flow, inventory, logistics, drug substance/product supply) to support clinical timelines.
- Align with Regulatory, Quality, and Clinical teams; communicate risks/statuses.
- Lead contract/agreement execution (CDAs, Quality Agreements, Technical Packages, SOWs, supply agreements).
- Author/manage technical transfer packages (process descriptions, batch records, analytical methods, specifications, CMC documentation).
- Support IND/CMC activities; partner with Quality for audits/gap assessments/corrective actions.
- Provide continued CDMO oversight during clinical transition (batch record reviews, deviations, change control, supply planning).
- Support CDMO qualification/selection (due diligence, RFP criteria, evaluate capabilities/capacity/compliance).
- Manage multiple concurrent programs with project plans, risk registers, and communication cadences.
- Maintain program documentation and reporting.
- Travel up to 25–30%.
Qualifications
- BSc +8 yrs, MSc +6 yrs, or PhD +3 yrs in Chemistry/Pharma Sci/Chem Eng/Biochemistry or related field.
- 5+ years in technology transfer, CMC, or manufacturing ops (pharma/biopharma/radiopharma).
- Experience managing CDMOs/contract manufacturing across regions (ex-US preferred).
- IND-enabling and Phase 1 clinical manufacturing experience.
- Strong plus: radiopharmaceutical GMP familiarity; supply chain/clinical logistics.
Skills
- Working knowledge of CMC/GMP, analytical method transfers, pharmaceutical quality systems.
- CDMO/vendor management; clinical supply chain knowledge (forecasting/logistics/cold chain/import-export).
- Ability to draft/execute key quality and regulatory documents.
- Project management (e.g., MS Project/Smartsheet; PMP a plus).
- Cross-functional collaboration and strong communication.
- Regulatory awareness (FDA and international agencies).
- Ethics/confidentiality.
Compensation / Benefits (as stated)
- San Diego, CA: $136,894–$165,884.
- Health coverage (medical/pharmacy/dental/vision), 401(k), disability and life insurance; Paid Time Off.
Application Instructions
- Job requisition: R1601085.
- Own end-to-end technology transfer of radiopharmaceutical drug products from internal development to US and international CDMO partners (plans, timelines, success criteria).
- Manage CDMO relationships across the manufacturing lifecycle; track milestones, resolve issues, and ensure quality/compliance/delivery.
- Coordinate clinical supply chain (material flow, inventory, logistics, drug substance/product supply) to support clinical timelines.
- Align with Regulatory, Quality, and Clinical teams; communicate risks/statuses.
- Lead contract/agreement execution (CDAs, Quality Agreements, Technical Packages, SOWs, supply agreements).
- Author/manage technical transfer packages (process descriptions, batch records, analytical methods, specifications, CMC documentation).
- Support IND/CMC activities; partner with Quality for audits/gap assessments/corrective actions.
- Provide continued CDMO oversight during clinical transition (batch record reviews, deviations, change control, supply planning).
- Support CDMO qualification/selection (due diligence, RFP criteria, evaluate capabilities/capacity/compliance).
- Manage multiple concurrent programs with project plans, risk registers, and communication cadences.
- Maintain program documentation and reporting.
- Travel up to 25–30%.
Qualifications
- BSc +8 yrs, MSc +6 yrs, or PhD +3 yrs in Chemistry/Pharma Sci/Chem Eng/Biochemistry or related field.
- 5+ years in technology transfer, CMC, or manufacturing ops (pharma/biopharma/radiopharma).
- Experience managing CDMOs/contract manufacturing across regions (ex-US preferred).
- IND-enabling and Phase 1 clinical manufacturing experience.
- Strong plus: radiopharmaceutical GMP familiarity; supply chain/clinical logistics.
Skills
- Working knowledge of CMC/GMP, analytical method transfers, pharmaceutical quality systems.
- CDMO/vendor management; clinical supply chain knowledge (forecasting/logistics/cold chain/import-export).
- Ability to draft/execute key quality and regulatory documents.
- Project management (e.g., MS Project/Smartsheet; PMP a plus).
- Cross-functional collaboration and strong communication.
- Regulatory awareness (FDA and international agencies).
- Ethics/confidentiality.
Compensation / Benefits (as stated)
- San Diego, CA: $136,894–$165,884.
- Health coverage (medical/pharmacy/dental/vision), 401(k), disability and life insurance; Paid Time Off.
Application Instructions
- Job requisition: R1601085.