Key Responsibilities

1. Technical Leadership & Process Optimization

- Upstream Strategy : Lead the design, optimization, and troubleshooting of Solid-Phase Peptide Synthesis (SPPS) protocols, including difficult sequences and modification chemistry.
- Downstream Scaling : Direct the scaling up of Preparative HPLC and RP-HPLC purification methods from analytical to pilot/production scale.
- Troubleshooting : Serve as the subject matter expert (SME) to resolve complex synthesis failures, poor solubility issues, and challenging impurity profiles.
- Tech Transfer : Oversee the seamless transfer of peptide processes from the R&D; stage to validation and commercial production batches.

2. Operations & Team Management

- Resource Allocation : Manage a team 22 members of engineers/scientists, assigning daily synthesis, purification, and lyophilization tasks.
- Project Timelines : Ensure projects meet strict delivery schedules while optimizing raw material consumption (resins, protected amino acids, solvents).
- Equipment Oversight : Oversee the calibration, maintenance, and qualification of automated synthesizers, Prep-HPLC systems, and lyophilizers.
- Data Integrity : Review and sign off on chromatograms, analytical data,



Master Batch Records (MBRs), and final batch release reports.
- Compliance Lead : Ensure the laboratory strictly adheres to GLP/GMP guidelines, data integrity standards, and safety regulations.
- SOP Authoring : Author, update, and approve Standard Operating Procedures (SOPs), deviation reports, and Corrective and Preventive Actions (CAPA).

Candidate Qualifications & Requirements

- Education : B.Tech / M.Tech in Biotechnology or Chemical Engineering OR M.Sc. / Ph.D. in Organic, Analytical, or Biochemistry.
- Experience : 15 to 18+ years of core industrial experience in peptide chemistry, with at least 2+ years in a supervisory or team-leading role.
- Technical Mastery : Deep, provable expertise spanning both upstream chain-building (cleavage, coupling) and downstream isolation (salt-exchange, TFF, freeze-drying).
- Software Literacy : High proficiency in chromatography data software (e.g., Empower, Chromeleon) and data analysis tools.
- Soft Skills : Robust project management, clear cross-functional communication, and a proven track record of mentoring junior scientists.

📌 Assistant General Manager, Manufacturing (India)
🏢 Amneal Pharmaceuticals
📍 India