Assistant General Manager, Manufacturing

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Amneal Pharmaceuticals in Ahmedabad, Gujarat is seeking a Senior Scientist to lead the design, optimization, and troubleshooting of SPPS protocols, including challenging sequences, and to oversee tech transfer from R&D to production.

You will manage a team of 22 engineers/scientists, ensuring strict project timelines and efficient material usage while maintaining GLP/GMP compliance and data integrity. Proficiency in Empower/Chromeleon and strong mentoring are essential.

Qualifications

• Education in Biotechnology/Chemical Engineering or Biochemistry with high-level degrees.
• 15 to 18+ years of core industrial peptide chemistry experience; 2+ years in supervision.
• Deep expertise in upstream SPPS and downstream purification/isolation.
• Proficiency in chromatography data software and data analysis tools.
• Strong PM, cross-functional communication, and mentoring skills.

Responsibilities

• Lead design, optimization, and troubleshooting of SPPS protocols for difficult sequences.
• Scale Purification methods from analytical to pilot/production scales (HPLC).
• Oversee transfer of peptide processes from R&D to validation and production.
• Manage a 22-person team of engineers/scientists and ensure on-time delivery.

Skills

Leadership

Cross-functional communication

Project management

Mentoring

Data analysis

GLP/GMP knowledge

Empower

Chromeleon

Education

B.Tech / M.Tech in Biotechnology or Chemical Engineering OR MSc/PhD in Organic, Analytical, or Biochemistry

Tools

Empower

Chromeleon

Job description

Ahmedabad City, Gujarat, India

Job Description

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).

Qualifications

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: Strong project management, clear cross-functional communication, and a proven track record of mentoring junior scientists.

Job Info

• Job Identification 8984
• Job Category Manufacturing Process Operations