Specialist / Senior Specialist Analytical Transfer & Validation

Overview

Summary

The Specialist / Senior Specialist - Analytical Transfer & Validation supports the transfer and the validation of analytical method and all analytical activities related to the product life cycle, from Raw Materials to DS & DP testing;

acts as Subject Matter Expert (SME) for complex problem solving, method improvement, audit and inspection. May be required to coordinate the activities of consultants in his / her area of responsibility.

Key Responsibilities

• Manage comprehensive validation studies to assess the performance of analytical methods, in accordance with regulatory guidelines and Good Manufacturing Practices
• Write, review analytical transfer / validation / verification protocols, data, reports, test methods and other related documentations
• Analyze and interpret results of validation studies and prepare detailed reports
• Act as the analytical technical expert on multiple programs, collaborate with internal and external team members to move projects forward.

Collaborate with Program Management to ensure clear expectations and successful results. Is responsible for the planning, the timelines and the cost reporting.

Provide regular communication of analytical status to Program Managers

• Supports the budget definition and tracking, definition of resource needs for execution of activities under his / her responsibilities
• Manage external laboratories, if any, ensuring effective coordination, costs and timelines follow-up. Set guidance and provide support in method development, validation, verification, and transfers to the external labs
• Manage the implementation of new raw material by defining the required tests, in alignment with the pharmacopeia
• Act as SME and participate in internal / external audits and HA’s Inspections for method validation / transfer
• Perform regulatory and technical watch to ensure compliance with constantly evolving requirements

Education and Experience

• Master's or PhD in biology, chemistry, biochemistry, chemical engineering, or a related field with 5 years of biotech industry experiences, in a GMP environment
• Knowledge, Skills, Abilities
• Broad understanding of Cell-based assays, PCR, ELISA, Liquid Chromatography, Capillary Electrophoresis, Virology, Microbiology and Microbiology.
• Excellent skills in project management
• Excellent interpersonal, written and communication skills
• Perfect knowledge of ICH guidelines on analytical methods, stability, comparability and specification
• Knowledge of biologics CMC and IND / BLA submission is preferred
• Fluent in French and English

Disclaimer : The above statements are intended to describe the general nature and level of work performed by employees assigned to this job.

They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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