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API Manufacturing Leader

API Manufacturing Leader

Symbiotec Pharmalab Pvt. Ltd.Indore, Republic Of India, IN
21 days ago
Job description

Key Responsibilities :

Production & Operations Management :

  • Manage end-to-end upstream processes including chemical reactions , crystallization , solvent recovery , and work-up operations .
  • Plan and execute daily production activities to meet output, quality, and yield targets.
  • Monitor critical process parameters (CPPs) and ensure adherence to process design and safety.

Compliance & Documentation :

  • Ensure GMP compliance , and adherence to regulatory and safety guidelines (USFDA, EDQM, TGA, WHO).
  • Review and approve Batch Manufacturing Records (BMRs) , SOPs , Deviation Reports , and Change Controls related to upstream activities.
  • Prepare and support regulatory audits , customer audits , and internal inspections .

    • People & Resource Management :

  • Lead and develop a team of shift engineers, supervisors, and operators .
  • Schedule manpower, oversee training and ensure adherence to SOPs and safety practices .
  • Foster a culture of accountability , teamwork , and continuous improvement .

    • Process & Quality Improvement :

  • Collaborate with R&D, Technology Transfer, and QA / QC teams to ensure smooth tech transfer and scale-up of new products.
  • Drive process optimization to improve yield, reduce cycle time , and minimize solvent loss .
  • Lead investigation of deviations, process failures , and implement corrective actions .

    • Plant & Equipment Oversight :

  • Oversee the operation and maintenance of key upstream equipment :
  • Reactors (GLR / SSR), condensers, scrubbers, distillation units, receivers , etc.
  • Coordinate with the Engineering team for preventive maintenance and equipment validation .

    • Inventory & Cost Control :

  • Monitor raw material consumption, solvent usage, and utility consumption.
  • Drive cost-reduction initiatives without compromising quality or compliance.

    • Key Skills and Competencies :

  • Deep understanding of chemical reaction engineering and process safety .
  • Expertise in hazardous reaction handling , including exothermic and pressure reactions.
  • Sound knowledge of GMP , cGMP , ICH , and regulatory requirements .
  • Strong leadership, team management, and problem-solving abilities.
  • Proficiency in production software (e.G., SAP, DCS, MES) is an added advantage.

    • Educational Qualifications :

  • B.E. / B.Tech in Chemical Engineering or equivalent OR M.Sc. in Chemistry / Organic Chemistry / Industrial Chemistry

    • Experience Required :

    15+ years of progressive experience in API manufacturing , with significant expertise in upstream operations including reaction handling , crystallization , and phase separation .

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    Manufacturing Leader • Indore, Republic Of India, IN

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