BrightOwl Loader Loading

Drug Substance Development (Sr) Lead Mechelen Belgium,  

Galapagos (company)

Posted on : 22 December 2017

Project Description

Ref 330

As Lead drug substance development CMC, you will be responsible for the drug substance (API) development and up-scaling strategy and execution thereof for various development projects.

This includes:
- API synthesis route development and solid state development

- Upscaling, manufacturing of non-GMP and GMP batches
- Evaluation of stability data and impurity identification/synthesis
- Evaluation of physico-chemical data of lab scale/pilot scale batches and adjustment of processes as needed

- Knowledge of potential mutagenic impurity assessment

- Preparation of drug substance development/manufacturing source documents related to clinical trial applications and prepare responses to drug substance related regulatory questions
- Selection and management of contractors executing the drug substance development/manufacturing activities
- Collaboration with Quality and Compliance department to assure that CROs are performing according to cGMPs
- Interaction with analytical and drug product CMC team members to build the CMC development plan and ensure execution thereof


The successful candidate has a PhD in organic chemistry and at least 5 years of experience in drug development, especially in drug substance development/upscaling area.


Mechelen, Belgium

Find a Job Find Candidates

Similar Jobs

More jobs from Galapagos

Other jobs in Belgium

Other jobs in Mechelen

Other jobs from Galapagos in Mechelen

Other similar job in Mechelen

Other Jobs

Most Recent Searches

Most Famous Searches

You might also like