Scientist( I - II ) - Reputable Pharmaceutical Company

RESPONSIBILITIES

· Design and develop analytical methods for drug substances and drug products (oral solid dosage forms and/or injectables) in compliance with regulatory requirements for global markets (USFDA, EMA, etc.).

· Perform literature searches to support method development.

· Conduct analytical method development and validation as per ICH guidelines (e.g., specificity, precision, accuracy, linearity, robustness).

· Execute pre-formulation and characterization studies including Excipient compatibility studies, Forced degradation studies, Stability-indicating method development

· Hands-on experience with analytical instruments such as: HPLC / UPLC, UV-Visible Spectrophotometer, Dissolution Apparatus, Karl Fischer, pH meter, etc.

· Apply Design of Experiments (DoE) for method optimization and robustness evaluation.

· Analyse and interpret analytical data related to: Assay, Dissolution, Content uniformity, Impurities / related substances and stability data

· Prepare and review analytical documents such as: Analytical Method Development Reports (AMDR), Validation protocols and reports, STPs, Regulatory documentation (ANDA, DMF sections)

· Demonstrate strong documentation, investigation, and communication skills for cross-functional collaboration.

Qualification

M Pharmacy, B pharmacy, MSc Chemistry