Technology Transfer Specialist

Technology Transfer Specialist is responsible for ensuring the smooth, compliant, and structured transfer of assays, reagents, consumables, and instrumentation to Production. The role combines strong documentation capability with hands-on technical understanding of IVD workflows. This position ensures that manufacturing-ready documentation is provided, risk controls are implemented, and Production and Quality Control groups are fully trained and equipped to begin routine production.

The role directly supports ISO 13485 (7.3.8 Design Transfer) and ISO 14971 (Risk Management) requirements and acts as the central link between R&D, D&D, QA/RA, Supply Chain, and Manufacturing.

Key Responsibilities

1. Technology Transfer Execution

• Lead structured transfer of assays, consumables, reagents, and instrumentation.
• Create and manage Technology Transfer Plans, Design Transfer Files, build schedules, and readiness assessments.
• Coordinate pilot lots, engineering lots, and Process Performance Qualification (PPQ) batches.
• Ensure all design outputs are complete, reviewed, and approved before transfer.

2. Documentation Ownership & DMR Development

• Develop and maintain Device Master Records (DMR) including:
• SOPs, batch manufacturing records (BMRs), work instructions (WI)
• QC plans, test methods, sampling plans
• Equipment specifications and calibration procedures
• Ensure documents meet QMS standards and are audit-ready.

3. Process & Risk Controls Implementation

• Embed all risk controls from ISO 14971 into production workflows.
• Ensure traceability between design inputs design outputs process controls acceptance criteria.
• Identify gaps in manufacturability, robustness, or risk mitigation and drive corrective actions.

4. Cross-Functional Coordination

• Serve as the bridge between R&D, D&D, QA/RA, QC, Supply Chain, and Production.
• Facilitate training sessions for Manufacturing teams on new processes, risks, and acceptance criteria.
• Ensure cross-functional alignment on transfer status, timelines, readiness, and documentation.

5. Validation & Compliance Support

• Support process validation activities (IQ/OQ/PQ) in collaboration with PET scale-up engineers.
• Ensure QC methods, test instructions, and acceptance criteria are clear and validated.
• Support preparation of evidence for internal audits and external regulatory assessments.

6. Post-Transfer Support

• Monitor early production batches to ensure process stability and quality.
• Assist in troubleshooting deviations, NCs, and CAPAs related to transferred products.
• Maintain continuous improvement of documentation and transfer processes.

Qualifications & Experience

• Advanced degree (Bachelors, Masters, or PhD) in Life Sciences, Biotechnology, Biochemistry, Molecular Biology, or a related discipline, combined with 5+ years of experience in IVD technology transfer, quality control, validation, or manufacturing support.
• Strong understanding of ISO 13485, ISO 14971, FDA, IVDR, MDR , other relevant standards, guidelines and structured documentation practices.
• Experience preparing and managing DMRs, DHRs, SOPs, and BMRs.
• Working knowledge of diagnostics workflows (e.g. clinical chemistry, hematology, PCR/qPCR, sample prep, consumables).
• Excellent technical writing, documentation, and cross-functional communication skills.