The Manager/Sr. Manager – Technology Transfer will lead and oversee the complete technology transfer lifecycle for new and existing products to the Indore manufacturing site. The role involves strategic planning, cross-functional leadership, process optimization, troubleshooting, and ensuring regulatory compliance throughout the transfer and scale-up process.
Key Responsibilities
1. Technology Transfer Strategy & Execution
Lead end-to-end technology transfer for formulations/processes from R&D, other sites, or external partners.
Drive planning, feasibility evaluation, and risk assessment for new product introductions.
Oversee scale-up, pilot, validation, and commercial batch execution.
2. Process Optimization & Troubleshooting
Identify gaps in process/technology and propose corrective & preventive actions.
Provide technical guidance on equipment selection, process capability, and optimization.
Support manufacturing teams during deviations and ensure quick resolution.
3. Documentation & Regulatory Compliance
Review and approve all TT protocols, reports, MFR/BMR, SOPs, and validation documents.
Ensure compliance with cGMP, WHO, USFDA, MHRA, and other regulatory expectations.
Prepare documentation required for audits and regulatory submissions.
4. Cross-Functional Collaboration
Coordinate with R&D, QA, QC, Production, Engineering, Supply Chain, and Regulatory Affairs.
Lead cross-functional meetings to align all departments for smooth technology transfer.
Provide training to plant teams on new processes and technical requirements.
5. People & Project Management
Manage and mentor the technology transfer team; ensure timely completion of deliverables.
Drive multiple projects simultaneously with clear timelines and progress tracking.
Implement best practices to improve efficiency and reduce transfer timelines.
6. Data Analysis & Reporting
Analyze process data to ensure robustness, consistency, and scalability.
Prepare concise technical summaries, presentations, and management reports.
Review process deviations, root cause analyses, and CAPA implementation.
Qualifications
M.Pharm / B.Pharm / M.Tech / M.Sc (Pharma, Chemistry, Biotech, Chemical Engineering).
8–15+ years of relevant experience in technology transfer, formulation development, or technical services.
Experience in regulated pharmaceutical manufacturing is essential.
Key Skills & Competencies
Strong knowledge of formulation development, scale-up, validation, and manufacturing processes.
Strong project management, planning, and team leadership skills.
Excellent problem-solving and decision-making skills.
Ability to work with senior leadership and cross-functional teams.
Strong documentation and regulatory understanding.
Preferred Experience
Exposure to solid oral dosage / nasal etc
Experience in handling regulatory inspections during tech transfer.
Prior experience working in multi-site or global technology transfer environments.