Technology Transfer Scientist / Executive / Senior Executive - Peptide

• 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 environments.