Manager, Technology Transfer & CDMO Operations

Responsibilities:
- Lead and manage end-to-end technology transfer for radiopharmaceutical drug products from internal development to US and international CDMO partners; develop technology transfer plans, timelines, and success criteria.
- Serve as primary point of contact for CDMO partners; manage day-to-day relationships, track milestones, resolve technical/operational issues, and ensure quality, compliance, and delivery.
- Manage and coordinate clinical supply chain operations (material flow, inventory, logistics) to support drug substance/product supply for clinical trial timelines.
- Align with Regulatory Affairs, Quality Assurance, and Clinical Operations; communicate risks and status updates.
- Lead preparation, negotiation, and execution of CDAs, Quality Agreements, Technical Packages, SOWs, and supply agreements with Legal, Quality, and Procurement.
- Author and manage technical transfer packages (process descriptions, batch records, analytical methods, specifications, and CMC documentation).
- Support IND/CMC activities; facilitate CDMO audits, gap assessments, and corrective action plans.
- Maintain CDMO oversight through clinical transitions (batch record reviews, deviation investigations, change control, ongoing supply planning for Phase 1 and beyond).
- Support due diligence and selection of new CDMO partners; develop RFP criteria and evaluate capabilities and compliance readiness.
- Manage multiple concurrent technology transfer and CDMO programs; maintain project plans, risk registers, and communication cadences.
- Author/review/maintain program documentation and provide regular status reporting.
- Travel up to 25–30% for CDMO site visits, audits, and operational reviews.

Qualifications:
- Education: BSc + 8 years, MSc + 6 years, or PhD + 3 years in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or related field.
- 5+ years of direct experience in technology transfer, CMC, or manufacturing operations in pharmaceutical/biopharmaceutical/radiopharmaceutical settings.
- Minimum 5+ years? (as stated: 5+ years) technology transfer/CMC/manufacturing.
- Demonstrated experience managing CDMOs/contract manufacturing relationships across multiple geographic regions (ex-US preferred).
- Experience supporting IND-enabling activities and Phase 1 clinical manufacturing.
- Familiarity with radiopharmaceutical manufacturing and GMP requirements (strong plus).
- Supply chain management and clinical logistics background (preferred).

Skills/Required & Preferred:
- Working knowledge of CMC drug development, GMP manufacturing, analytical method transfers, and pharmaceutical quality systems.
- Ability to manage complex external manufacturing relationships and resolve issues.
- Clinical supply chain knowledge (forecasting, logistics, cold chain, import/export regulatory considerations).
- Experience drafting/executing Quality Agreements, CDAs, Technical Packages, SOWs, and regulatory CMC documentation.
- Strong project management; experience with MS Project/Smartsheet (PMP a plus).
- Cross-functional collaboration (Regulatory, Quality, Clinical, Legal, Operations).
- Excellent written/verbal communication; presents technical/operational info clearly.
- Proactive, solutions-oriented risk identification/escalation.
- Familiarity with FDA and international regulatory requirements (EMA, Health Canada).
- Strong ethics and confidentiality.

Benefits:
- Health Coverage: Medical, pharmacy, dental, and vision.
- Wellbeing Support (e.g., Employee Assistance Programs).
- Financial protection (e.g., 401(k), disability, life insurance, etc.).
- Paid Time Off (including flexible time off or annual paid vacation depending on employee type).

Application instructions:
- Requisition: R1601085 (Manager, Technology Transfer & CDMO Operations).