Technology Transfer Specialist (OSD & Derma)

Job Description:

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 on-site 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.

Qualification & Experience

• B.Pharm / M.Pharm (Pharmaceutics preferred)
• Additional certifications in Process Validation, Quality Systems, Lean Six Sigma, or Project Management will be an added advantage.
• Minimum work experience: 7-15 years of experience