Manager Analytical R&D(API)

Hyderabad - India

Monthly Salary: Not Disclosed

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Job Summary

Company: Listed pharma company having API Peptides Formulation and Biologics business.

Department: Analytical Research and Development for Active Pharmaceutical Ingredient(API)

Position : Manager - AR&D/ADL

Experience: 12-15 Y in HPLC Method development

Job description:

To develop HPLC / UPLC methods for related substances/ assay/ Recation monitoring/ non-carryover/ genotoxic impurities in APIs as per ICH Q2 requirements.
To conduct forced degrdataion studies and evaluate mass balance
To evalute LC MS data to identify degradation products
To qualify reference and working standards
To conduct Analytical method transfer to the manufacturing sites
To respond Regulatory deficiences and Quality control related issues
To troubleshoot HPLC / UPLC instruments and methods
To maintain HPLC / UPLC instruments and analytical columns.
To communicate with cross functional teams
To comply with Standard Operating Procedures (SOPs)
To mainatain GLP environment

Company: Listed pharma company having API Peptides Formulation and Biologics business. Department: Analytical Research and Development for Active Pharmaceutical Ingredient(API)Position : Manager - AR&D/ADLExperience: 12-15 Y in HPLC Method developmentJob description:To develop HPLC / UPLC methods fo...