Analytical Development Scientist (CMC)
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
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