Assistant General Manager Manufacturing

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 2,000,000 - 4,800,000; Full time

Job summary

Amneal Pharmaceuticals in Gujarat, India is seeking a Technical Leader to helm peptide synthesis operations, guiding upstream SPPS design and downstream purification scale-up with a focus on optimization and problem-solving.

The role requires 15–18+ years of peptide chemistry experience, strong leadership, mentoring ability, and a track record in GLP/GMP compliance and seamless tech transfer from R&D to production.

Qualifications

• Education and experience as stated in the job posting.
• 15 to 18+ years of core industrial peptide chemistry experience.
• 2+ years in supervisory or team-leading role.
• Proven mastery of both upstream and downstream peptide processing.

Responsibilities

• Lead design, optimization, and troubleshooting of SPPS protocols.
• Scale-up of Preparative HPLC from analytical to pilot/production.
• Resolve complex synthesis failures and impurities as SME.
• Oversee tech transfer from R&D to production batches.
• Manage a 22-member team of engineers/scientists.
• Ensure on-time delivery while optimizing material use.
• Oversee calibration and qualification of synthesizers and lyophilizers.
• Review MBRs, chromatograms, and batch release data.
• Ensure GLP/GMP compliance and safety.
• Author and update SOPs and CAPAs.

Skills

Project management

Cross-functional communication

Mentoring junior scientists

Soft skills

Education

B.Tech / M.Tech in Biotechnology or Chemical Engineering

M.Sc. / Ph.D. in Organic, Analytical, or Biochemistry

Tools

Empower

Chromeleon

Job description

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-function communication, and a proven track record of mentoring junior scientist.