Sr Research Scientist, LCMS-ARPL-LCMS AR (Bangalore, KA, IN, 560099) chez APOTEX

Job Summary

• Perform the Analytical activities based on requirement and as per the appropriate standard operating procedures in Analytical Research and Development and ARD Test Centre department.
• To ensure analytical and research activities with current regulatory needs.
• To build analytical capacity with-in the department, to ensure resource utilization, Lower cost of operation, Manpower optimization, Space utilization and customer focus.
• To ensure and adapt Apotex quality values in order to make quality pharmaceuticals.
• Method Development, Inprocess Testing & Analytical Method Validation for drug substance, drug product ,Intermediates and Raw materials.
• Nitrosamine testing.

Job Responsibilities

• Ensures all analytical tests are done according to the test method, GMP, SOP/WI and Guidelines
• Reviews all analytical data generated by Analytical Research and Development and ARD-Test Centre · Understands the detailed analytical procedures and guidelines.
• Validation of analytical methods for drug substance, drug product, intermediates and raw materials.
• Preparation of analytical method validation protocol for drug substance, drug product, intermediates and raw materials.
• Preparation of validation summary report for analytical method validation and online documentation of analysis in laboratory notebook
• Analytical Method transfer.
• Stability study sample analysis.
• Additional Test request analysis
• LCMS analysis for Finished Product , Raw Material and Intermediate / In-Process Analysis.
• Standard characterization by LCMS.
• Nitrosamine testing of raw material, intermediate, drug substance and drug product.
• Documentation
• Unknown peak investigation/identification by LCMS
• Calibration of instruments /equipment.
• Maintenance of the instrument through equipment logbook
• Upkeep of Laboratory cleanliness, safety and Good Laboratory Practices (GLP).
• Method development and partial validation by LCMS
• Coordination and follow up with service Engineers for the Instruments calibration and preventive maintenance.
• Initiate and report if any incident to the analysis and notify the supervisor for seeking resolution.
• Performs all work in compliance with our Code of Conduct and business ethics and related policies and with the legal and regulatory requirements that apply to our job activities
• Works as a member of a team to achieve all outcomes.
• Operates in accordance with our code of Conduct business, ethics and all established regulatory, compliance and safety requirements
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. 
• To adhere the EHS policy and procedure in routine activities
• To involving EHS related activities on need basis
• All other duties as assigned.

Job Requirements

• Education
  • Master’s degree in Applied chemistry
• Knowledge, Skills and Abilities
  • Experience in ARD Operations.
  • Handling of Analyst Software
  • Highly Responsible, organized, self-motivated with excellent analytical aptitude, Good communication,project management skills and Personality development virtues.
• Experience
  • 9+ years of Experience