Amneal Pharmaceuticals

Assistant General Manager, Manufacturing

Amneal Pharmaceuticals  •  State of Gujarāt, IN (Onsite)  •  6 hours ago
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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.
  1. 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: Strong project management, clear cross-functional communication, and a proven track record of mentoring junior scientists.
Amneal Pharmaceuticals

About Amneal Pharmaceuticals

Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.

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Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.

Industry
Chemicals & Materials
Company Size
5,001-10,000 employees
Headquarters
Bridgewater, New Jersey
Year Founded
2002
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