SummaryThe Manager, Technology Transfer & CDMO Operations is a key contributor to the advancement of RayzeBio's radiopharmaceutical programs, responsible for leading end-to-end technology transfer activities and CDMO relationship management across both domestic and international manufacturing partners. This role serves as the primary operational and technical liaison between internal stakeholders and external CDMOs, ensuring seamless transfer of radiopharmaceutical processes from development into clinical manufacturing. The Manager will oversee the full lifecycle of CDMO engagement - from partner selection and onboarding through ongoing clinical supply chain management - while closely aligning with Regulatory, Quality, and Clinical teams to ensure compliance and program continuity. This position requires strong project management capabilities, a working knowledge of CMC and GMP principles, and the ability to drive cross-functional execution in a fast-paced, dynamic environment.
Job ResponsibilitiesEssential duties and responsibilities include the following. Other duties may be assigned.- Technology Transfer Leadership: Own and manage the end-to-end technology transfer process for radiopharmaceutical drug products from internal development to external CDMO partners, both within the US and internationally. Develop and execute comprehensive technology transfer plans, timelines, and success criteria to ensure on-schedule, compliant transfer of processes and analytical methods.
- CDMO Management: Serve as the primary point of contact for CDMO partners throughout the manufacturing lifecycle. Manage day-to-day relationships, track performance against agreed-upon milestones, resolve technical and operational issues, and ensure CDMOs meet quality, compliance, and delivery expectations during and beyond clinical trials.
- Supply Chain Oversight: Manage and coordinate the clinical supply chain for radiopharmaceutical programs, including material flow, inventory management, logistics planning, and coordination of drug substance and drug product supply to support clinical trial timelines.
- Cross-Functional Alignment: Partner closely with Regulatory Affairs, Quality Assurance, and Clinical Operations teams to ensure that all CDMO activities and technology transfer deliverables align with regulatory strategy, quality standards, and clinical program requirements. Proactively communicate risks and status updates to internal stakeholders.
- Contract & Agreement Execution: Lead the preparation, negotiation, and execution of key program documents including Confidential Disclosure Agreements (CDAs), Quality Agreements, Technical Packages, Statements of Work (SOWs), and supply agreements in collaboration with Legal, Quality, and Procurement.
- Technical Package Development: Author and manage the development of comprehensive technical transfer packages, including process descriptions, batch records, analytical methods, specifications, and supporting CMC documentation required for CDMO onboarding and regulatory submissions.
- Regulatory & Quality Support: Collaborate with Regulatory Affairs to ensure that technology transfer activities support IND filings and CMC sections. Partner with Quality to facilitate audits, gap assessments, and corrective action plans at CDMO sites.
- Clinical Phase Transition & Continued Oversight: Maintain active CDMO oversight as programs transition into clinical trials, including participation in batch record reviews, deviation investigations, change control processes, and ongoing supply planning to support Phase 1 and beyond.
- Vendor Qualification & Selection: Support due diligence, evaluation, and selection of new CDMO partners. Develop RFP criteria and evaluate capabilities, capacity, and compliance readiness for domestic and international manufacturing sites.
- Project Management: Lead and manage multiple concurrent technology transfer and CDMO programs using structured project management approaches. Maintain detailed project plans, risk registers, and communication cadences with both internal teams and external partners.
- Documentation & Reporting: Author, review, and maintain program documentation including technology transfer reports, meeting minutes, action trackers, and CMC regulatory documents. Provide regular status reporting to program leadership and cross-functional teams.
- Travel: Up to 25-30% travel required, including visits to CDMO sites domestically and internationally for technology transfer campaigns, audits, and operational reviews.
Education and Experience- Education: BSc + 8 years, MSc + 6 years, or PhD + 3 years in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or a related field with relevant pharmaceutical or biopharmaceutical industry experience.
- Minimum of 5+ years of direct experience in technology transfer, CMC, or manufacturing operations within a pharmaceutical, biopharmaceutical, or radiopharmaceutical setting.
- Demonstrated experience managing CDMOs and/or contract manufacturing relationships across multiple geographic regions, including ex-US sites, strongly preferred.
- Experience supporting IND-enabling activities and Phase 1 clinical manufacturing programs.
- Familiarity with radiopharmaceutical manufacturing operations and GMP requirements is a strong plus.
- Background in supply chain management and clinical logistics for pharmaceutical drug products preferred.
Skills and Qualifications- Technical Proficiency: Working knowledge of CMC drug development principles, GMP manufacturing, analytical method transfers, and pharmaceutical quality systems.
- CDMO & Vendor Management: Proven ability to manage complex external manufacturing relationships, hold partners accountable to timelines and quality standards, and resolve issues collaboratively and efficiently.
- Supply Chain Knowledge: Solid understanding of clinical supply chain operations, including forecasting, logistics, cold chain management, and import/export regulatory considerations for pharmaceutical materials.
- Document Authoring: Experience drafting and executing Quality Agreements, CDAs, Technical Packages, SOWs, and regulatory CMC documentation.
- Project Management: Strong organizational and project management skills; experience with project tracking tools (e.g., MS Project, Smartsheet, or equivalent). PMP certification a plus.
- Cross-Functional Collaboration: Demonstrated ability to work effectively across Regulatory, Quality, Clinical, Legal, and Operations teams to drive program execution.
- Communication: Outstanding written and verbal communication skills; ability to present complex technical and operational information clearly to internal stakeholders and executive leadership.
- Problem-Solving: Proactive, solutions-oriented mindset with the ability to anticipate risks, escalate appropriately, and drive timely resolution in a fast-paced environment.
- Regulatory Awareness: Familiarity with FDA and international regulatory requirements (EMA, Health Canada, etc.) as they relate to CDMO operations, technology transfer, and clinical manufacturing.
- Ethics & Confidentiality: Strong professional ethics and integrity, with the ability to manage sensitive business and technical information appropriately.
- Applies AI to improve team execution and decision-making
Physical DemandsWhile performing duties, the employee is regularly required to sit, stand, reach with hands and arms, and communicate effectively via verbal and written channels. Occasional lifting and/or moving up to 30 pounds may be required during site visits. Specific vision abilities include close and distance vision. Occasional on-site visits to manufacturing facilities may require use of protective clothing, gloves, and safety glasses.
Work EnvironmentPrimarily an office/hybrid work environment, with regular travel to domestic and international CDMO and manufacturing sites. Site visits may involve laboratory and manufacturing environments requiring adherence to applicable safety and GMP protocols.
Compensation Overview:San Diego - RayzeBio - CA: $136,894 - $165,884
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include:Paid Time Off
- US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
- Phoenix, AZ, Puerto Rico and RayzeBio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
RayzeBio and Bristol Myers SquibbRayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.
