Key Responsibilities

Technology Transfer

- Lead end-to-end technology transfer projects from R&D; to commercial manufacturing.
- Execute site-to-site, product-to-product, and customer technology transfer activities.
- Review and interpret product development reports, process development data, and analytical methods.
- Prepare and review Technology Transfer Protocols (TTP), reports, risk assessments, and supporting documentation.
- Ensure smooth scale-up from laboratory/pilot batches to commercial manufacturing.
- Coordinate engineering, exhibit, validation, and commercial batches.

Cross Functional Coordination

- Act as the primary coordinator between R&D;, Manufacturing, QA, QC, Validation, Engineering, Regulatory Affairs, Supply Chain, and customers.
- Conduct project review meetings and monitor project milestones.
- Identify project risks and implement mitigation plans to avoid delays.

Process & Manufacturing Support

- Provide technical support during manufacturing of technology transfer batches.
- Troubleshoot manufacturing issues related to formulation, filling, sterilization, lyophilization (where applicable), and packaging.
- Support optimization of manufacturing processes to improve yield and efficiency.
- Ensure successful execution of process validation batches.

Documentation & Compliance

- Prepare and review:
- Technology Transfer Protocols & Reports
- Batch Manufacturing Records (BMR)
- Process Flow Diagrams




- Product Risk Assessments
- Change Controls
- CAPAs
- Deviation Investigations
- Product Quality Review inputs
- Ensure documentation complies with cGMP and data integrity requirements.

Regulatory Compliance

- Ensure compliance with:
- USFDA
- EU GMP
- PIC/S
- ICH Guidelines
- WHO GMP
- Support regulatory inspections and customer audits.
- Provide technical justifications for regulatory queries related to transferred products.

Validation Support

- Coordinate with Validation for:
- Process Validation
- Media Fill
- Cleaning Validation
- Hold Time Studies
- Equipment Qualification
- Ensure successful validation and commercial readiness.

Customer & CMO Coordination

- Coordinate with international customers for technology transfer deliverables.
- Participate in technical discussions with customers and Contract Manufacturing Organizations (CMOs).
- Review customer requirements and ensure successful implementation.

Continuous Improvement

- Identify opportunities for process optimization and cost reduction.
- Drive operational excellence initiatives.
- Implement best practices in technology transfer and knowledge management.

Team Management (Senior Manager)

- Lead and mentor the Technology Transfer team.
- Allocate projects and monitor performance.
- Develop departmental SOPs and capability-building initiatives.

📌 Technology Transfer Manager (Nalagarh)
🏢 Immacule Life Sciences
📍 Nalagarh