Process analytical- Pharma

7 days ago

Panjim, India Symbiosis Management Consultants Full time

interested candidates can share their cvs -

Job Description:
The role of the Analytical Chemist is to undertake analytical research and development activities to aid and support the development of scalable synthetic routes for drug substances/intermediates. The incumbent will be responsible for developing analytical methods, performing routine and non-routine analysis, and providing analytical support to process chemistry teams to ensure product quality as per customer and regulatory requirements.

Key Accountabilities

  • Undertake analytical method development & validation for raw materials, intermediates, and APIs.
  • Provide analytical support for process improvement, scale-up, and technology transfer.
  • Ensure preparation of technical reports, protocols, and documentation as per cGMP and ICH guidelines.
  • Support troubleshooting activities in coordination with process chemists and QC teams.
  • Maintain instruments (HPLC, GC, Auto-titrator, Wet/Classical Analysis) and perform calibrations as per SOPs.
  • Plan and organize analytical lab activities in alignment with project timelines.
  • Ensure compliance with HSEQ, cGMP, GLP, and QMS systems.
  • Provide coaching and mentoring to juniors/trainees.

Responsibilities

  • Develop analytical methods for routine and stability studies using HPLC & GC.
  • Execute analytical method transfer (direct/indirect) as per project and GMP needs.
  • Perform analysis for raw material, in-process, and finished product samples.
  • Maintain accurate laboratory records, technical documentation, and ensure regulatory readiness.
  • Conduct safe handling, disposal of chemicals, and uphold best practices in lab safety.
  • Collaborate with cross-functional teams for analytical support during scale-up/commercial trials.
  • Support in DMF documentation and customer audits.

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