04 Aug
|
Dr. Reddy's Laboratories
|
Hyderabad
04 Aug
Dr. Reddy's Laboratories
Hyderabad
Job Description
Job Summary
We are seeking an experienced Technology Transfer Specialist to lead and support technology transfer activities from R&D; to commercial manufacturing and between internal and external manufacturing sites. The role involves process scale-up, technology absorption, process validation, risk assessment, troubleshooting, and continuous improvement initiatives for Oral Solid Dosage (OSD) and Dermatological (Topical) products. The incumbent will work closely with cross-functional teams to ensure successful product commercialization, regulatory compliance, process robustness, and operational excellence.
Key Responsibilities
- Act as a Subject Matter Expert (SME) for technology transfer activities, facilitating seamless transfer of products and processes from R&D; to manufacturing and between partner manufacturing sites.
- Lead technology absorption activities by collaborating with R&D;, Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain teams.
- Assess product and process feasibility for transfer and provide technical recommendations regarding manufacturing equipment, batch size determination, process design, material handling, containment systems, environmental controls, and tooling requirements.
- Prepare, review, and approve process validation protocols, validation reports, technology transfer documents, process monitoring reports, risk assessments,
and other GMP-compliant documentation.
- Execute and monitor scale-up, exhibit, registration, validation, and commercial manufacturing batches while ensuring compliance with approved processes and quality standards.
- Coordinate in office and remote technology transfer support for customers and partner manufacturing facilities.
- Support customer and manufacturing teams in troubleshooting process-related issues during technology transfer, scale-up, validation, and commercial production.
- Conduct process investigations, root cause analyses, and risk assessments for deviations and manufacturing challenges.
- Design and execute laboratory studies and process improvement experiments to validate root causes and implement CAPA.
- Prepare technical investigation reports and collaborate with Manufacturing and Quality teams to implement process improvements.
- Evaluate the technical capabilities and suitability of external development and manufacturing facilities.
- Provide technical and cost-related inputs on equipment, materials, and manufacturing requirements.
- Ensure adherence to cGMP, QMS requirements, regulatory requirements, and internal quality standards.
- Drive continuous improvement initiatives focused on process robustness, manufacturing efficiency, and cost optimization.
📌 Technology Transfer Specialist (OSD & Derma) (Hyderabad)
🏢 Dr. Reddy's Laboratories
📍 Hyderabad