Analytical Development Scientist (CMC)

Remote, USA Full-time Posted 2025-03-13

If you are an experienced analytical development specialist looking for an exciting new opportunity, I am partnering with an up and coming start up in south east France, who are looking to bring in an experienced contractor to support further product development.

This role will support and supervise all technical elements of the analytical method development, validation and implementation... projects at the CMO, as the business prepares to move into clinical phase 2 stage. This will also include writing and reviewing the analytical sections of Module 3 IND submissions.

The particular focus is on sustained release injectable formulations of small molecules.

What You Need To Know
? Workload between 1 day to 2.5 days per week (0.2 to 0.5 FTE)
? 12 month duration, with possibility of extension
? Highly competitive hourly rate
? Flexible work location (work from home ? no need to be based in France)
? Minimal travel required ? but occasional need for expenses paid CMO / client site meetings
? Proficiency in English and French ? documentation completed in English

Some The Key Experience Required
? 10+ years experience in analytical development and validation
? Experience with injectables, ideally complex dosage forms
? Experienced of the FDA is ideal

For further information, please contact Mark Bux-Ryan

Interim, freelance, contract, process, manufacturing, CMC, development, Transfer, technical, CMO, CDMO, stakeholder, client, project, management, injectable, sterile, molecule, analytical, development, method, validation, module, IND, submissions

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