- Key Responsibilities

Technology Transfer
- Technology transfer of peptide API processes from laboratory to manufacturing scale.
- Review development reports, batch records, process descriptions, and analytical methods.
- Prepare and execute technology transfer protocols and reports.
- Coordinate with R&D;, Manufacturing, Quality Assurance, Quality Control, Engineering, teams.
- Support site-to-site transfer and customer technology transfer projects.

Process Scale-Up & Manufacturing Support
- Evaluate process scalability and identify critical process parameters (CPPs).
- Support scale-up activities for Solid Phase Peptide Synthesis (SPPS) and solution-phase peptide synthesis processes.
- Troubleshoot process-related issues during engineering, exhibit, validation, and commercial batches.
- Analyse process performance and recommend improvements for yield, quality, cycle time, and cost optimization.
- Monitor process consistency during routine manufacturing.

Process Validation & Regulatory Compliance
- Support process validation and cleaning validation activities.




- Prepare risk assessments, process flow diagrams, and gap assessment reports.
- Ensure compliance with cGMP, ICH, FDA, EMA, and other regulatory requirements.
- Provide technical support during regulatory inspections and customer audits.

Peptide Process Expertise
- Hands-on knowledge of:
- Solid Phase Peptide Synthesis (SPPS)
- Peptide cleavage and deprotection
- Purification using Preparative HPLC
- Lyophilization processes
- Peptide isolation and drying techniques
- Process optimization and impurity control
- Understanding of amino acid chemistry, coupling reagents, peptide impurities, and degradation pathways

Required Qualifications
- M.Sc. / M.Pharm. / B.Pharm. / M.Tech in Chemistry, Pharmaceutical Sciences, Biotechnology, or related discipline.
- Minimum 5+ years of industrial experience in peptide API development, manufacturing, or technology transfer.
- Experience in GMP-regulated pharmaceutical

📌 Technology Transfer Scientist (Vadodara)
🏢 Alembic Pharmaceuticals
📍 Vadodara