Manager, Technology Transfer & CDMO Operations

Job Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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

• 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

• Working knowledge of CMC drug development principles, GMP manufacturing, analytical method transfers, and pharmaceutical quality systems.
• Proven ability to manage complex external manufacturing relationships, hold partners accountable to timelines and quality standards, and resolve issues collaboratively and efficiently.
• 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.
• Strong organizational and project management skills; experience with project tracking tools (e.g., MS Project, Smartsheet, or equivalent).
• PMP certification a plus.
• Demonstrated ability to work effectively across Regulatory, Quality, Clinical, Legal, and Operations teams to drive program execution.
• Outstanding written and verbal communication skills; ability to present complex technical and operational information clearly to internal stakeholders and executive leadership.
• Proactive, solutions-oriented mindset with the ability to anticipate risks, escalate appropriately, and drive timely resolution in a fast-paced environment.
• Familiarity with FDA and international regulatory requirements (EMA, Health Canada, etc.) as they relate to CDMO operations, technology transfer, and clinical manufacturing.
• Strong professional ethics and integrity, with the ability to manage sensitive business and technical information appropriately.