Senior Technical Service Officer - Analytical & Method Development

Senior Officer - Technical Service

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

For more information visit: www.apotex.com.

 

Job Summary

• Perform the Analytical activities based on requirement and as per the appropriate standard operating procedures in AD department, Apotex Pharmachem India Pvt. Ltd.
• To ensure analytical and research activities with current regulatory needs.
• To build analytical capacity within 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

• 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.
• 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.
• Unknown peak identification /Investigation analysis 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.
• Works as a member of a team to achieve all outcome.
• Works in a safe manner collaborating as a team member to achieve all outcome.
• 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 involve EHS related activities on need basis
• All other duties as assigned.

Job Requirements

 Education

Master’s degree in chemistry

Knowledge, Skills and Abilities

• Experience in AD Operations.
• Handling of Analyst Software
• Highly Responsible, organized, self-motivated with excellent analytical aptitude, Good communication,project management skills and Personality development virtues.

      Experience

 4+ years of Experience.

At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed. 

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

 

Experience Level

Senior Level