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API Synthesis Lead

API Synthesis Lead

PI Health Sciences LtdHyderabad, Republic Of India, IN
10 days ago
Job description

Job Title : Research Scientist / Senior Research Scientist – Process R&D

Department : R&D – Process Development

Industry : CDMO / API

Purpose of the Role :

To lead and execute the development, optimization, and scale-up of robust, cost-effective, and regulatory-compliant chemical processes for Active Pharmaceutical Ingredients (APIs) and intermediates, ensuring smooth technology transfer from lab to kilo lab and manufacturing.

Key Responsibilities

1. Strategic Responsibilities

  • Drive innovation by designing synthetic routes that align with project timelines and regulatory requirements.
  • Contribute to technology differentiation strategies that enhance the CDMO’s scientific credibility and client value proposition.
  • Collaborate with cross-functional teams (Analytical, QA / QC, and Regulatory) to support integrated drug development solutions.

2. Operational Responsibilities

  • Perform route scouting and literature searches, and develop robust and scalable chemical processes using QbD principles.
  • Conduct laboratory experiments for reaction optimization, impurity profiling, and process safety assessment.
  • Prepare and review technical reports, SOPs, and technology transfer documents.
  • Ensure compliance with GMP / GLP and EHS standards during lab-scale and pilot-scale operations.
  • Participate in troubleshooting during scale-up or commercial production batches and provide technical support during client audits.
  • 3. Financial Responsibilities

  • Optimize process economics by reducing cycle time, yield improvement, and minimizing raw material costs.
  • Support cost estimation activities during project proposals or client RFQs by providing technical insights.
  • 4. People & Collaboration Responsibilities

  • Guide junior team members on experimental planning, data interpretation, and documentation best practices.
  • Promote a culture of safety, learning, and innovation within the team.
  • Work closely with program management and business development to align project goals with customer expectations.
  • Qualifications & Experience

  • M.Sc. (Organic Chemistry) / PhD
  • 3–7 years of experience in Process R&D, preferably in CDMO organizations
  • Hands-on expertise in synthesis, scale-up, impurity profiling, and technology transfer
  • Familiarity with analytical techniques (HPLC, GC, NMR) and regulatory documentation
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    Lead • Hyderabad, Republic Of India, IN

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