Manager-Tech Transfer (Transdermal)
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Job Location:
Monthly Salary:
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
About Client:
It is a leading global pharmaceutical company specializing in oncology APIs (Active Pharmaceutical Ingredients) and formulations.
Roles And 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.
Key Skills
- Restaurant Experience
- Customer Service
- Employee Evaluation
- Management Experience
- Math
- Employment & Labor Law
- Sanitation
- Leadership Experience
- P&L Management
- Mentoring
- Supervising Experience
- Restaurant Management
