Analytical R&D Chemist

Flychem; Telangana; Presencial; INR 400.000 - 700.000; Jornada completa

Descripción de la vacante

Flychem Private Limited seeks enthusiastic chemistry graduates to join our Analytical Research & Development team in India. The role focuses on analytical method development, method validation and support for pharmaceutical intermediates and APIs.

You will perform method development, validation, impurity profiling, stability studies and support for process development, with adherence to GLP, GMP and ICH guidelines.

Formación

• MSc in Chemistry with analytical emphasis preferred.
• 1–3 years in Analytical R&D or API analysis.
• Strong knowledge of HPLC/GC/UV and related methods.
• Familiar with GLP, GMP and ICH guidelines.
• Good documentation and communication skills.

Responsabilidades

• Perform analytical testing of pharmaceutical intermediates and APIs using HPLC, GC, UV and other techniques.
• Develop and optimise analytical methods for assay, related substances, residual solvents and other quality parameters.
• Perform analytical method validation and verification as per ICH guidelines.
• Conduct impurity profiling and quantification of process-related and degradation impurities.
• Perform material, in-process, intermediate and finished API analysis.
• Support investigations related to OOS, OOT, atypical results and laboratory deviations.
• Conduct stability studies and support accelerated and long-term stability testing.
• Assist in analytical method transfer from AR&D to QC and other locations.
• Support Process R&D activities during reaction monitoring, process optimization and plant-scale-up.
• Maintain analytical records, chromatograms and laboratory notebooks.

Conocimientos

Analytical Chemistry

Problem-solving

Documentation

Teamwork

Educación

MSc in Chemistry

Herramientas

HPLC

GC

UV

Descripción del empleo

We are looking for enthusiastic and motivated chemistry graduates to join our Analytical Research & Development team, focusing on analytical method development, method validation and analytical support for pharmaceutical intermediates and Active Pharmaceutical Ingredients (APIs).

The candidate will be involved in analytical method development, method optimisation, impurity profiling, analytical testing, stability studies and analytical support for process development and plant-scale-up activities. Candidates should have a sound understanding of analytical instruments, pharmaceutical quality systems, GLP, GMP and relevant ICH guidelines.

Key Responsibilities

• Perform analytical testing of pharmaceutical intermediates and APIs using HPLC, GC, UV and other analytical techniques.
• Develop and optimise analytical methods for assay, related substances, residual solvents and other quality parameters.
• Perform analytical method validation and verification as per applicable ICH guidelines.
• Conduct impurity profiling, identification and quantification of process-related and degradation impurities.
• Perform raw material, in-process, intermediate and finished API analysis.
• Support analytical investigations related to OOS, OOT, atypical results and laboratory deviations.
• Perform stability studies and support accelerated and long-term stability testing.
• Assist in analytical method transfer from AR&D to QC and other manufacturing locations.
• Support Process R&D activities during reaction monitoring, process optimisation and plant-scale-up.
• Maintain analytical records, chromatograms, calculations, laboratory notebooks and analytical reports.
• Prepare and review analytical method procedures, SOPs, specifications and method validation protocols and reports.
• Follow GLP, GMP, data integrity and laboratory safety requirements.
• Develop knowledge of relevant ICH guidelines, including ICH Q2(R2), Q14, Q3A, Q3B, Q3C, Q3D, Q7, Q9 and Q10.
• Coordinate with Process R&D, QC, QA and Production teams to support product development and commercialisation.

Qualifications and Skills

• M.Sc. in Chemistry; Analytical Chemistry / Organic Chemistry preferred.
• 1-3 years of experience in Analytical R&D, pharmaceutical intermediates or API analysis.
• Good theoretical and practical knowledge of HPLC and GC.
• Basic knowledge of UV, FTIR and other analytical instruments.
• Understanding of analytical method development, optimisation and validation.
• Knowledge of assay, related substances, impurity profiling and residual solvent analysis.
• Understanding of OOS/OOT investigations, stability studies and analytical documentation.
• Familiarity with GLP, GMP, data integrity and ICH guidelines.
• Good documentation, communication and problem-solving skills.
• Ability to work independently and collaboratively with cross-functional R&D teams.

Preferred Candidate Profile

Candidates with hands-on experience in HPLC, GC, analytical method development, method validation, impurity profiling and analytical support for API and pharmaceutical intermediate development will be preferred.