The Technology Transfer (TT) Department in a pharmaceutical industry plays a crucial role in ensuring the successful transfer of knowledge, processes, and technologies from one site to another. This could be from R&D to manufacturing, between manufacturing sites, or from a third party to the company.
Key Responsibilities of the Technology Transfer Department:
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Process Transfer & Scale-up:
- Transfer manufacturing processes from R&D to commercial production.
- Ensure smooth scale-up from laboratory to pilot plant and full-scale manufacturing.
- Optimize processes to maintain product quality and efficiency.
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Documentation & Compliance:
- Develop Technology Transfer Protocols (TTP) and Reports (TTR).
- Ensure compliance with GMP (Good Manufacturing Practices), FDA, EMA, ICH, and WHO guidelines.
- Maintain detailed records of manufacturing processes, analytical methods, and regulatory filings.
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Analytical Method Transfer:
- Transfer test methods from development laboratories to quality control (QC) labs.
- Ensure analytical methods are validated and reproducible at the receiving site.
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Risk Assessment & Troubleshooting:
- Identify potential risks during process transfer and develop mitigation strategies.
- Address scale-up challenges such as yield variation, impurity levels, and process deviations.
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Collaboration with Cross-Functional Teams:
- Work with R&D, Quality Assurance (QA), Quality Control (QC), Regulatory Affairs, and Manufacturing.
- Ensure alignment of technical knowledge, timelines, and regulatory expectations.
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Post-Transfer Support & Continuous Improvement:
- Monitor initial production batches at the receiving site.
- Provide training and technical support to the new manufacturing team.
- Continuously optimize processes for efficiency and cost reduction.
Technology Transfer Scenarios in Pharma:
- R&D to Production Site: Moving a new drug from the lab to a commercial plant.
- Site-to-Site Transfer: Transferring production between manufacturing facilities.
- Outsourcing to Contract Manufacturing Organizations (CMOs): Transferring technology to third-party manufacturers.
- Global Market Expansion: Adapting processes to meet different regulatory requirements.
Job location :- Indore
Qualification:- B.Pharm / M.Pharm
Experience :- 4 to 8 Years
Candidate must have exposure of working with any USFDA or MHRA approved Formulation OSD plant in Technology transfer department.
Disha Consultancy
Whatsapp: 7389919235
Mobile : 9302526235
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