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Senior Analytical Development Specialist

Il y a 2 mois

Lyon, Auvergne-Rhône-Alpes, France Actalent Temps plein
Job Summary

We are seeking an experienced Senior Analytical Development Specialist to join our team at Actalent. As a key member of our Pharmaceutical Development team, you will be responsible for providing technical supervision and support for the development, validation, and implementation of analytical methods at a Contract Manufacturing Organization (CMO).

Key Responsibilities
  • Technical Supervision: Provide technical guidance and support to the CMO's analytical development team to ensure the development, validation, and implementation of analytical methods meet regulatory requirements.
  • Method Development and Validation: Critically review and validate analytical documentation issued by the CMO, ensuring compliance with regulatory requirements and industry standards.
  • Regulatory Compliance: Ensure that all analytical requirements are met throughout the development and validation phases for the intended stage of drug product development and testing.
  • Documentation and Reporting: Write and review the analytical sections of Module 3 IND submissions, ensuring accuracy and compliance with regulatory requirements.
Requirements
  • Language Skills: Proficiency in both French and English is mandatory for day-to-day discussions and documentation.
  • Travel: Occasional travel to CMO or client sites is expected.
  • Workload: The expected workload will vary, starting at 20%, increasing to 50%, 12-month duration with possible extension.
Desired Profile
  • Experience: 10-15 years of experience in analytical method development and validation within GLP and GMP environments.
  • Skills: Proficiency in HPLC, GC, and Coulometry, experience with particle size distribution (laser light diffraction), skilled in dissolution testing, experience with injectables, particularly complex dosage forms.
  • Regulatory Knowledge: Strong knowledge of regulatory requirements and guidelines, particularly those of the FDA (EMA knowledge is a plus).
  • Documentation: Experience in writing Module 3 for FDA submissions is an advantage.