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 re

📌 Technology Transfer Manager (Nalagarh)
🏢 Immacule Lifesciences
📍 Nalagarh