Nextenti Tech Private Limited
Website:
nextenti.ai
Job details:
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
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