Expert Analytical Scientist

2 weeks ago

Hyderabad, Telangana, India beBeeAnalytical Full time ₹ 20,00,000 - ₹ 25,00,000
Scientific Professional Wanted

The role requires expertise in analytical method development, validation, structural characterization, elucidation, impurity profiling, and troubleshooting for drug substances (APIs) and its intermediates.

Key Responsibilities:

  • Develop, optimize, validate, and transfer analytical methods in line with ICH requirements.
  • Support characterization of raw materials, intermediates, and APIs.
  • Establish impurity profiles, assay methods, and residual solvent analyses.
  • Preparation of technical reports, quality reports, documentation, and handling audits.
  • Calibration of instruments as per schedules, qualification of standards, and its maintenance.
  • Creation and review of analytical documents and calibrations of equipment's.

Client Project Support:

  • Act as the technical point of contact for client analytical needs in development, scale-up, and commercial manufacturing stages.
  • Prepare and present technical data, development reports, and analytical strategies to clients.

Instrumentation & Troubleshooting:

  • Operate and maintain HPLC, GC, LC-MS, FTIR, UV, KF, DSC, and other relevant equipment.
  • Resolve technical and analytical challenges promptly to ensure project continuity.

Regulatory Compliance & Documentation:

  • Prepare method validation protocols & reports, method development reports, cut-off studies report, incident investigation reports, and Standard Operating Procedures.
  • Ensure adherence to internal procedures and data integrity principles during all testing activities.
  • Support client and regulatory audits (USFDA, EMA, MHRA, WHO).

Cross-functional Collaboration:

  • Work closely with process chemistry, formulation development, quality assurance, and manufacturing teams.
  • Support technology transfer between development and commercial sites.

Education & Experience:

  • M.Sc or M.Pharm with 10+ years' experience in the Analytical R&D; 4-5 years' experience with PhD.

Technical Skills:

  • Strong command of chromatographic, spectroscopic, and other analytical techniques.
  • Experience with method development for complex products and diverse client needs.
  • Proficiency in chromatography data systems (Empower, Chromeleon).
  • Regulatory Knowledge: ICH Q2, Q3, GMP, GLP guidelines.

Key Attributes:

  • Strong client-facing communication skills.
  • Ability to work in a fast-paced, deadline-driven environment.
  • High attention to detail and scientific rigor.
  • Effective multi-tasking and prioritization skills.

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