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CMC Drug Substance Specialist - Biotech - Charleroi

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. The company's 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 Substance) 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 Substance 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 process last optimizations, scale-up, process validation and cGMP manufacture.
  • Provide technical expertise for the drug substance (DS) processability, scale-up, manufacturing and testing.
  • Manage analytical activities and stability plans.
  • Attend drug substance (DS) key productions.
  • Identify potential chemical/technical, analytical, processing, stability, and compliance issues and recommends mitigation for emerging risks.
  • Review certificates of analysis, batch records and other technical documents.
  • Ensure DS supply for clinical studies and product launch.
  • Support in writing and reviewing CMC documents for INDs/IMPD/regulatory section submissions.
  • Liaise with other departments to provide them the requested CMC information. Ensure alignment with cross functional team.

Profile

  • Bachelor or Master in Chemistry.
  • 3-5 years CMC experience in small molecules, in drug substance (DS) from technical point of view.
  • Good understanding of DS synthesis, process development, scale-up and process validation.
  • Experience in analytical techniques, manufacturing and GMP.
  • Substantial experience working with CDMOs and leading their teams 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.
  • 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

Publication date

08.09.2022

Contact person

DORTU

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