Dualyx NV

(www.dualyx.com ), 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. Accountabilities 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 Qualifications 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 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

HR@dualyx.com . Job application

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