Tech Transfer (TDSODF) Senior Manager
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Job Location:
Monthly Salary:
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
Key Responsibilities
1. Technology Transfer & Scale-Up
- Lead transfer of transdermal patch formulations from lab/pilot scale to commercial manufacturing.
- Develop and execute Technology Transfer (TT) protocols and reports.
- Coordinate scale-up of coating lamination drying slitting and pouching processes.
- Ensure process reproducibility and product consistency during transfer.
2. Process Development & Optimization
- Provide technical expertise in:
- Adhesive systems (PSA-based drug-in-adhesive systems)
- Coating technologies (knife-over-roll slot die etc.)
- Backing membranes and release liners
- Solvent handling and drying systems
- Troubleshoot process issues during exhibit validation and commercial batches.
- Optimize critical process parameters (CPPs) and critical quality attributes (CQAs).
3. Validation & Documentation
- Prepare and review:
- Technology Transfer Dossiers
- Master Batch Records (MBR/BMR)
- Process validation protocols & reports
- Risk assessments (FMEA)
- Support process validation (PV) and PPQ batches.
- Ensure documentation complies with cGMP USFDA EMA and other regulatory standards.
4. Cross-Functional Coordination
- Work closely with:
- R&D
- Production
- Quality Assurance (QA)
- Quality Control (QC)
- Engineering
- Regulatory Affairs
- Act as primary technical liaison between sending and receiving sites.
5. Regulatory & Compliance Support
- Provide technical input for regulatory submissions (ANDA/NDA/DMF).
- Support audits and inspections (USFDA MHRA etc.).
- Ensure adherence to data integrity and quality standards.
6. Commercial & Lifecycle Management
- Support commercial batch manufacturing post-launch.
- Lead investigations (OOS OOT deviations CAPA).
- Drive continuous improvement initiatives for yield cost and process efficiency.
- Qualifications
- / / (Pharmaceutical Technology / Chemical Engineering) / PhD preferred.
- 10–18 years of relevant experience in transdermal patches.
- Strong experience in technology transfer and scale-up of transdermal systems.
- Exposure to regulated markets (US/EU) preferred.
Key Skills
- Program Management
- FDA Regulations
- Management Experience
- Facilities Management
- Clinical Development
- Data Management
- Quality Systems
- Project Management
- Research & Development
- GLP
- Budgeting
- Leadership Experience
