We are looking for an experienced Analytical Development Scientist to join our clients Pharmaceutical Development team on a contract basis. This role involves providing technical supervision and support for the development, validation, and implementation of analytical methods at a Contract Manufacturing Organization (CMO) as they prepare for clinical Phase 2.

The successful candidate will be crucial in maintaining the technical link between the company and the CMO's analytical development team. They will ensure that all regulatory and analytical requirements are met throughout the drug product development and testing process, with a particular focus on sustained release injectable formulations of small molecules. Are you ready to take your career to the next level in the heart of pharmaceutical innovation?

Role and Responsibilities:

• Provide technical supervision and support for the development, implementation, and validation of analytical methods at the CMO, with potential transfers between CMO sites.
• Critically review and validate analytical documentation issued by the CMO.
• Ensure regulatory and analytical requirements are met throughout the development and validation phases for the intended stage of drug product development and testing.
• Write and review the analytical sections of Module 3 IND submissions.

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 (once per trimester or semester) is expected.
• Workload: The expected workload will vary, starting at 20%, increasing to 50%, 12 month duration with possible extension

Desired Profile:

• 10-15 years of experience in analytical method development and validation within GLP and GMP environments.
• 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.
• Prior experience working at a CMO is a plus.
• Strong knowledge of regulatory requirements and guidelines, particularly those of the FDA (EMA knowledge is a plus).
• Experience in writing Module 3 for FDA submissions is an advantage.

Please get in touch if you require further details.

Job Title: Analytical Development Scientist

Location: Lyon, France

Job Type: Contract

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