Assistant General Manager, Manufacturing

Amneal Pharmaceuticals


Date: 2 weeks ago
City: Ahmedabad, Gujarat
Contract type: Full time
Key Responsibilities

 JOB DESCRIPTION

  • 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.
  • 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.

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