Hobson Prior are currently seeking for a CMC Drug Product Leader to join a fantastic pharmaceutical organisation on a permanent basis located in Gosselies. Our client is focused on finding and developing differentiated therapeutics.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this role, you will serve as the CMC SME on the development of rug product for new chemical entities, on formulation development, process development, from pilot scale to industrial and commercial scale.
• Responsible for preparing, evaluating and approving drug product source documents for CTA/IND.
• Partake in in responses to questions as the SME of drug product actions, working alongside the CMC Dossier Manager.
• Outline the drug product development method and guide the drug development actions at CDMOs.
• Recognise, select and handle CDMOs for both drug product development and production, non GMP and cGMP manufacture and scale up in assistance of ongoing clinical programs.
• Any other assigned duties.

Requirements:

• Educated to an advanced degree level or relevant technical training.
• Demonstrable experience in drug development and industrialisation.
• A background in formulation development, in industrial scale up and preparing for launch.
• Know-how of traditional oral dosage from production which involves technologies, for example: blending, wet/dry/spray granulation, tableting, capsule filling, coating, etc.
• Expertise on QbD, DoE, CPV (process validation).
• Acquaintance in clinical manufacturing and quality aspects of GMP manufacturing.
• Know-how of preclinical models in vivo and in vitro and drug development aspects.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

By providing your details and submitting this form, you confirm you have read and understood our privacy policy. We only share your personal details with our group companies at acaciumgroup.com/affiliates and those categories of third parties in our privacy policy at hobsonprior.com/privacy-policy.