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 settings.

📌 Technology Transfer Scientist / Executive / Senior Executive Peptide Vadodara
🏢 Alembic Pharmaceuticals
📍 Vadodara