The Technology Transfer Lead is responsible for leading and coordinating pharmaceutical technology transfer and contract manufacturing activities from initial technical assessment through manufacturing readiness, validation, and commercial production.
  The role serves as the primary technical interface among technology providers, internal cross-functional teams, and external manufacturing sites. It ensures that product, process, analytical, facility, equipment, packaging, and validation requirements are effectively translated into an integrated, practical, and executable technology transfer plan.
Key Responsibilities

• Lead end-to-end technology transfer projects, from initial technical assessment through successful transfer, validation, and commercial manufacturing readiness.
• Prepare, maintain, and manage Technology Transfer Plans, gap assessments, technical checklists, milestone plans, action trackers, risk registers, and decision logs.
• Coordinate knowledge transfer between the technology provider/sending site and the receiving manufacturing site.
• Support engineering, validation, and initial commercial batches, ensuring that all technical prerequisites are completed and closed prior to execution.
• Review and technically assess CTD documentation, with particular emphasis on Module 3.
• Extract and interpret manufacturing, formulation, process, analytical, packaging, stability, and validation requirements from the dossier.
• Identify and assess gaps between dossier requirements and the technical capabilities of candidate receiving sites.
• Prepare, coordinate, and manage technical clarification questions with technology providers and manufacturing partners.
• Apply strong knowledge of pharmaceutical manufacturing processes, particularly for biological and biotechnology products.
• Demonstrate practical understanding of sterile manufacturing, aseptic processing, vial filling, prefilled syringe (PFS) filling and assembly, plunger insertion, labeling, secondary packaging, lyophilization, and other related processes, as applicable.
• Participate in the technical assessment, selection, qualification, and onboarding of manufacturing sites and Contract Manufacturing Organizations (CMOs).
• Evaluate production lines, equipment, utilities, cleanrooms, batch-size capabilities, filling ranges, packaging capabilities, cold-chain requirements, production capacity, and validation readiness.
• Act as the primary technical focal point for external manufacturing sites and CMOs.
• Coordinate technical scope, deliverables, assumptions, timelines, interfaces, and responsibilities with manufacturing partners.
• Contribute to the technical sections of Manufacturing Agreements, Technology Transfer Agreements, and related technical appendices.
• Coordinate analytical method transfer requirements with QC teams while maintaining appropriate QC technical ownership.
• Coordinate technical readiness for engineering/trial batches, process validation, packaging validation, hold-time studies, cleaning validation, and shipping validation, where applicable.
• Coordinate technology transfer activities across Regulatory Affairs, Quality Assurance (QA), Quality Control (QC), Supply Chain, Manufacturing, Engineering, Procurement, Business Development, Finance, Legal, and Commercial functions.

Education & Experience

• Pharm.D. or degree in Pharmacy, or a Bachelor’s/Master’s degree in Pharmaceutical Engineering, Chemical Engineering, Biotechnology, Biochemical Engineering, Bioprocess Engineering, or another relevant scientific or engineering discipline.
• Preferably 7+ years of relevant pharmaceutical industry experience, including at least 3–5 years of experience in manufacturing, technology transfer, process development, CMO management, validation, or other related technical functions.
• Hands-on experience with biological and/or biotechnology products is strongly preferred.
• Experience in sterile manufacturing and/or aseptic processing is highly desirable.
• Previous involvement in at least one technology transfer, manufacturing transfer, scale-up, validation, or commercialization project is preferred.
• Experience working with external manufacturing sites and/or CMOs is strongly preferred.

Required Technical Competencies

• Pharmaceutical manufacturing processes and production technologies
• Biological and biotechnology manufacturing
• CTD documentation and Module 3 interpretation
• GMP requirements, sterile manufacturing, aseptic processing, and contamination control
• Production-line, equipment, utility, and facility capability assessment
• Technology transfer, technical gap analysis, and manufacturing site readiness assessment
• Contract manufacturing and CMO technical management
• Pharmaceutical packaging and container-closure systems
• Working knowledge of analytical method transfer and regulatory manufacturing requirements
• Technical risk assessment, root-cause analysis, and structured problem-solving