CMC Manager

Job Purpose

As Minoryx is growing, we are currently looking for a talented CMC Manager to strengthen the CMC Department to support their development programs and product launch. You will report to the Executive Director CMC & Supply Chain.

This position is an excellent opportunity to contribute actively to the advancement and the growth of a Phase 3 stage company while contributing to the development of a promising treatment. This role will be key in the growing organization.

Your responsibilities

In this exciting role as CMC Manager, you will be responsible for the following: 

• Monitor in-house and external CMC activities. Facilitate development and oversee execution of CMC activities.
• Manage CDMOs for process last optimizations, scale-up, process validation and cGMP manufacture.
• Identify potential technical, supply and compliance issues and recommends mitigation for emerging risks.
• Review technical documents.
• Prepare plans and timelines based on inputs from CDMOs teams. Contribute to implementing, maintaining business continuity of the product across the complete supply chain.
• Ensure Drug Product (DP) supply for clinical studies and product launch.
• Contribute to launch readiness from operational point of view. Contribute to prepare supply chain model and stock policy.
• Liaise with other departments to provide them the requested CMC information. Ensure alignment with cross functional team.

Requirements

• BSc or MSc in Chemistry.
• 3-5 years CMC experience in small molecules, in drug product (DP) from technical and operational point of view.
• Good understanding of DP process development, scale-up and process validation.
• Experience in manufacturing, supply chain/logistics and GMP is a must.
• Experience in production planning and in product launch preparation from operational point of view.
• Understanding of quality assurance.
• Substantial experience working with CDMOs and leading their teams is a plus.
• Experience in ERP systems is a plus.
• Open-minded with strong team spirit and excellent interpersonal skills.
• Ability to contribute to a continuous learning and process improvement environment.
• Agility, rapid response to changes without losing the ability of being organized.
• Ability to work independently and to collaborate with a group in a goal- and team-oriented setting.
• Effective communication skills.
• Fluency in English (written and spoken).

Our offer 

• A dynamic and ambitious work environment in a high qualified and experimented small team, with daily interactions with the headquarters in Spain.
• Permanent contract, full time job
• Location: Gosselies (Belgium) + 20% travelling + 2 days teleworking/week
• Start date: ASAP 

How to apply? 

If you are interested in this challenging opportunity, please address your application (CV and short motivation text, both in English) to our recruitment partner, Plus One:

Mrs Gaëlle Minet, by email on gminet@plusonesearch.be or apply on www.plusonesearch.be

Only selected candidates will be contacted.