Project Leader

BioLyo Technologies is a dynamic biotech company based in Ghent, Belgium, dedicated to the development of live bacterial micro-organisms to be used as vaccines or live biotherapeutic products (LBPs). The company provides services to third parties to help speed up the development of their Live Biologicals by offering GMP compatible and scalable process development, analytical development, process characterization and GMP QC services. Areas of expertise include medium optimization, fermentation & harvest strategies, and pre-and post-lyophilization formulation of live bacterial products. Quality by Design principles and Design of Experiments software are applied to perform process characterization to work towards commercial manufacturing, a service few CDMO’s offer. BioLyo has implemented a QMS, has a cGMP license for Quality Control testing of Investigational Medicinal Products (IMPs), and offers QC testing services for batch release and stability studies. In addition, BioLyo manages the cGMP manufacturing of IMPs at contracted CDMOs to support pre-clinical and clinical phases I to III for its clients.Due to expanding activities, BioLyo needs to strengthen its team with a Project Leader. This role will be key in guiding BioLyo projects to deliver successful production processes and quality control of drug products to clients for pre-clinical and clinical evaluation.Job Description: Give input to client and supplier contracts and to risk assessments at project onboardingProvide Work Breakdown Structure of a project plan, allocating time and budgetCoordination between internal departments: Development, Quality Control and Quality AssurancePoint of contact for clients and contracted CDMOsOrganize Kick-off meeting, make project charterHost internal team meetings, client meetings and meetings with the contracted CDMOFollow-up tasks, report on project progress, manage scope changes and resource assignmentsManage activities outsourced to service providersReview development protocols and summary reports for alignment with the quotations/contractsSupport in process risk assessments according to the principles of quality risk managementSupport review of CMC sections of regulatory submissionsEnsure timely signing and sending of development and QC protocols and reportsOrganize wrap up meetings to capture lessons learnedInitiate shipment of products and follow up arrival with the clientInitiate and verify invoicing to the clientEducation and Competences:PhD or Master’s Degree in pharmaceutical science, biotechnology, bioengineering, biomedical sciences or a related field, or equivalent by experienceMinimum of 5 years of experience in a GMP environment in pharma or biotech, of which a minimum of 2 years of demonstrated Project Leader experienceExperience in overseeing outsourced manufacturing activities is preferredWorking knowledge of Fermentation and Lyophilization of live organisms or biologics is a strong plusKnowledge of cGMP and both EU and USA guidelines for pharmaceutical development, scale up and technology transferCertificate of project management training and communication courses are welcomedAbility to lead and motivate a team, to guide complex discussions and reach consensusA heart for communication and relationship buildingFluent in English, written and spoken.Excellent planning and organizational skills, focus on prioritiesPragmatic mindset of continuous improvement to get things doneWhat we offer:Working location in the vibrant Tech Lane Ghent Science Park in Zwijnaarde, easily accessible by public transportFlexible working hours according to a sliding scheduleAbility to work full-time, but this is not a requirementA competitive salary package with meal vouchers, a mobile phone subscription, maximum bicycle allowance, a pension plan and hospitalization insuranceA young team of colleagues and regular team building activitiesPlease send your application, including your CV and a motivation letter to info@biolyotech.com before 15 December 2025.