Technology Transfer Manager

Immacule Lifesciences; Solan; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Immacule Lifesciences in Himachal Pradesh (Solan) seeks a Senior Manager to lead end-to-end technology transfer from R&D to commercial manufacturing, ensuring seamless scale-up and meticulous documentation.

You will coordinate with R&D, Manufacturing, QA, Regulatory Affairs, and customers to drive process validation, coaching, and continuous improvement, while maintaining cGMP data integrity.

Qualifications

• Lead technology transfer projects from R&D to commercial manufacturing.
• Review development reports, process development data, and analytical methods.
• Coordinate site-to-site, product-to-product, and customer technology transfer activities.
• Prepare and review Technology Transfer Protocols (TTP), reports, risk assessments, and supporting documentation.
• Ensure documentation complies with cGMP and data integrity requirements.

Responsibilities

• Lead end-to-end technology transfer projects from R&D to commercial manufacturing.
• Coordinate engineering, validation, and commercial batches as part of tech transfer.
• Review and interpret product development reports, process data, and analytical methods.
• Prepare and review Technology Transfer Protocols (TTP), reports, risk assessments, and supporting documentation.
• Ensure smooth scale-up from lab/pilot batches to commercial manufacturing.
• Coordinate with international customers and CMOs for tech transfer deliverables.

Skills

Technology transfer

Project management

Cross-functional coordination

Regulatory compliance

Documentation & cGMP

Quality systems

Job description

• 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:
• Batch Manufacturing Records (BMR)
• Process Flow Diagrams
• 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.
• 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.