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
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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