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Director CMC

Director CMC

Dualyx NV (, is a Ghent-based biotech company dedicated to the development of novel Treg based therapies to address the needs of patients with difficult-to-treat autoimmune diseases. The company is currently fast-growing and has a pipeline with highly promising immune modulating programs including DT-001, an antibody agonist program targeting the TNF receptor 2 (TNFR2) which is currently in IND-enabling studies. TNFR2 is widely regarded as a master control switch for immunosuppression, making it highly attractive for Treg therapies. Dualyx also has a pipeline of additional Treg programs in early development. Dualyx is backed by a group of well-respected investors including: Fountain Healthcare Partners, Forbion, Andera Partners, V-Bio Ventures, BGV, PMV, VIB, HTGF and GFF.

At the moment, we are looking for a Director CMC to strengthen our dynamic research team in Ghent (full-time employment; 40-60% on-site).

The Director CMC will play a critical role as the subject matter expert (SME) and project lead of Pharmaceutical Drug Development. She/he will be responsible leading all CMC activities in the company in collaboration with the CDMO, including process development, optimization, scale-up and manufacturing and for each phase the relevant analytics in support of the company’s developing pipeline and programs. The Director CMC must be able to collaborate effectively with a multidisciplinary internal and external team of scientists and engineers.


  • Lead Chemistry, Manufacturing and Controls (CMC) activities for the company’s large molecule development project

  • Work with CMC consultants and designated contract development and manufacturing organizations (CDMOs) to facilitate successful project execution, achievement of key deliverables and budget and FTE goals

  • Serve as subject matter expert (SME) with internal team members and be able to clearly explain the purpose of experiments and experimental results to senior management: Collaborate cross functionally with internal and external stakeholders such as Discovery, Regulatory Affairs, Toxicology, Medical / Clinical and Quality

  • Prepare, review and approve study protocols, study reports, manufacturing batch records, development campaign reports, CMC regulatory submission documents and SOPs

  • Proactively demonstrate leadership by advising and sharing knowledge and expert opinions with peers and senior management

  • Build project timelines and manage the critical path

  • Translate strategies into CMC operational plans

  • Develop CMC project budgets and budget forecasts to support monthly, quarterly and major financial budget cycles

  • Develop and analyse scenarios, risk assessment and mitigation planning

  • Participate in consultant and CRO selection activities


  • PhD or Master in Pharmacy or similar

  • At least 8 years of CMC experience in biologicals drug product (DP) from technical and operational point of view

  • Good understanding of DS and DP process development, scale-up and process validation

  • Experience in manufacturing, supply chain/logistics and GMP is a must

  • Experience in production planning from operational point of view in collaboration with the CDMO

  • Understanding of quality assurance

  • Substantial experience working with CDMOs is a must

  • 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)

We offer you the unique opportunity to join a high-potential biopharmaceutical company and contribute critically to Dualyx’ development. If you believe your profile fits this job description, please send your application to

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