Company: Regulatory Professionals
Closing Date: 20 Nov 16
Type: Full Time
Salary (£): On Application
Drug Substance Development Senior Lead - Biotech Antwerp Area, Belgium OR East Paris, France: Salary: €70,000-€90,000 depending on experience - Are you looking to use your strong drug substance development experience to work for an innovative clinical-stage Biotech?
Drug Substance Development Senior Lead - Biotech
Location: Antwerp Area, Belgium OR East Paris, France
Job type: Permanent position
Salary: €70,000-€90,000 depending on experience
Job reference: J23999
- Are you looking to use your strong drug substance development experience to work for an innovative clinical-stage Biotech?
- Want to lead and project manage various development projects?
- Do you have an interest in growing with a highly successful mid-sized company?
We are currently supporting a very successful clinical-stage Biotech company who have formed partnerships with some of the biggest names in the industry. They focus on small molecule medicines for immune-related diseases.
You will be acting as the Senior Lead for drug substance development CMC, responsible for up-scaling strategy and overseeing various development projects.
- Leading API (synthesis route and solid state) development
- Manufacturing non GMP and GMP batches and upscaling
- Compile/ prepare CMC documentation for clinical trial applications and preparing responses to Agency questions about drug substance
- Evaluation of stability data and impurity identification
- Lead and build the CMC development plan
- Select and manage CRO"e;s and contractors within the drug substance development department
- At least 5 years"e; experience in drug substance development CMC
- Strong theoretical and practical knowledge of the drug development process
- Experience in preparing drug substance development reports for CMC sections of IND/IMPD/NDA submissions
- Fluent English
Remember if this role is not suitable for you or you are no longer looking for a new job please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice.
Key words: Belgium, Mechelen, Flanders, Antwerp, Flemish, Paris, France, Romainville, Biotech, Biotechnology, Manager, CMC, Drug substance, Drug substance development, GMP, Regulatory Affairs, Regulatory Affairs Lead, Senior Lead, Drug development, clinical trials, early phase, early phase drug development
3rd floor 33 Blagrave Street Reading
|Tel:||+44 (0)118 9522 797|
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