- Working at Minoryx
We are driven and committed to making new treatments available for patients suffering from severe, orphan CNS diseases. Our culture is defined for being perseverant and passionate for what we do, and that we all share the motivation of leveraging science to helping others.
- Our core values
All our activites are performed under an ethical code which is driven by the following values:Get involvedEnjoy the challenge, have fun!We careMoving forward togetherOur core values
All our activites are performed under an ethical code which is driven by the following values:Get involvedEnjoy the challenge, have fun!We careMoving forward together
- Open Positions
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.
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.
- 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).
- 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 firstname.lastname@example.org or apply on www.plusonesearch.be
Only selected candidates will be contacted.
We are always looking for talented individuals willing to join our company and share our vision and commitment to making new treatments available for patients suffering from severe, orphan CNS diseases.
If you are interested in sending your application, please contact us at: