CMC Drug Product Specialist

工作内容

Company

Our client is a clinical stage biotech company leading the development of new therapies for rare diseases. The company’s leading program involves the treatment of X-linked Adrenoleukodystrophy, a fatal neurodegenerative disease affecting both pediatric patients and adults. Their treatment could become the first approved treatment for the most prevalent form of the disease.

The company is now preparing for presenting a marketing authorization application (MAA) in Europe while in the US is under discussions with FDA on the path to approval. The company recently secured one of the largest rounds of EU biotech in 2022. The headquarters of our client is located near Barcelona in Spain and this position will be located in their subsidiary near Charleroi.

As the company is growing, we are currently looking for a talented CMC Specialist (in Drug Product) to strengthen the CMC Department to support their development programs and product launch. You will report to the director of CMC activities.

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 this growing organization.

Role

In this exciting role as CMC Drug Product Specialist, 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 scale-up, process validation, cGMP manufacturing and supply chain/logistics.
• 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 internal cross functional team.

Profile

• Bachelor or Master in Pharmacy.
• 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).

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 + 20% travelling + 2 days teleworking/week
• Start date: ASAP