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Global Head of Regulatory Affairs - Bio-Pharma/Biotech, Biotechnology - Gosselies

iTeos Therapeutics is a privately-held, clinical-stage biopharmaceutical company dedicated to extending and improving the lives of cancer patients by designing and developing next generation immunotherapies. iTeos Therapeutics is advancing its two main programs into a phase I/II clinical stage. The first program is an insurmountable and non-brain penetrant adenosine A2A receptor antagonist. The second program is a human ADCC-enabling anti-TIGIT antibody.

Based in Gosselies, Belgium and Cambridge, MA, iTeos Therapeutics was founded out of the Ludwig Institute for Cancer Research (LICR) and the de Duve Institute (UCLouvain) in 2011. In March 2020, the Company completed a $125 million Series B2 financing led by 6 main US Venture Capitalists. All previous investors including Fund +, VIVES II and SRIW, as well as SFPI, also participated in this funding round. For more information, please visit www.iteostherapeutics.com.

iTeos Therapeutics is now a world-class actor in the sector. To carry on its growth and reinforce its team, iTeos Therapeutics is looking for a (m/f) :

Global Head of Regulatory Affairs

The Global Head of Regulatory Affairs will be a key member of iTeos Therapeutics’ Leadership Team and be responsible for developing iTeos Therapeutics’ global regulatory strategy, represent iTeos in regulatory interactions and ensure execution of regulatory requirements and provide input into internal quality systems. This role requires expert interpretation of requirements relating to the development and licensing of cancer therapeutics and communication to cross-functional teams to create innovative regulatory strategies for targeted small molecules and biologics to treat cancer. This position will report to the Chief Medical Officer and will have extensive interface with the senior management team.

Main responsibilities:
  • Responsible for developing innovative global regulatory strategies and working with the cross-functional project team on execution.
  • Leads interactions with global regulatory agencies.
  • Represents regulatory affairs in the leadership team and on cross-functional project teams to provide regulatory guidance and education through the interpretation of regulations, policies, procedures, guidelines, and compliance requirements.
  • Provides oversight for regulatory staff (whether at CRO or internally) and assesses and makes recommendations on staffing requirements.
  • Develops and manages regulatory submissions and related supplements and amendments with the support of a CRO.
  • Responsible for developing and maintaining regulatory strategy documents.
  • Interacts directly with health authorities and maintains excellent relationship with regulatory personnel.
  • Works with the team to integrate biomarker/companion diagnostic strategies into the development of assigned programs.
  • Educates company on regulatory requirements and evolving trends and disseminates regulatory policy and intelligence relevant to the business.
  • Provides regulatory due diligence assessments of new business opportunities.
Profile:
  • Advanced degree in a scientific or health-related field
  • Seasoned professional with at least 10 years of regulatory affairs experience in the biopharmaceutical industry
  • Exceptional communication and presentation skills to articulate complex regulatory strategy and decision-making both internally and externally
  • Experience and comfort with pushing the boundaries and asking challenging questions both of the internal team and of the regulatory authorities.
  • Experience in providing strategic advice on integrated regulatory development plans and executing regulatory strategy for cancer therapeutics.
  • In-depth working knowledge of regulations, guidance, policies, and procedures pertinent to drug and biologics development and operational knowledge of IND/CTA and NDA/BLA/MAA submissions.
  • Experience with development of biomarkers and IVD companion diagnostics devices preferred.
  • Exceptional writing skills with experience in drafting and submitting timely drug and biologic applications to health authorities.
  • Track record of building an excellent relationship with the FDA, EMA and other regulatory agencies.
  • Quality mindset.

LEADERSHIP CHARACTERISTICS :

  • Entrepreneurial, resourceful, energetic, self-starter
  • Approaches challenges with creativity and pragmatism
  • Ability to engage team to achieve goals without direct authority
Offer:
  • A stimulating scientific position within a high-potential innovative biotech company.
  • The opportunity to work in a science-driven, dynamic, human‐sized, respectful and professional environment.
  • A challenging scientific and business growth in which you get to bring your knowledge and skills.
  • Varied contacts inside the company, the biotech/pharma sector and the scientific world.
  • A long-term contract and an attractive salary package in line with the position responsibilities and your experience.

Chief Executive Officer (CEO) - Medical Device - Mont-Saint-Guibert

Digital Orthopaedics is an innovative e-Health company providing a comprehensive Clinical Decision Support System (CDSS) for musculoskeletal pathologies, for the foot and ankle in particular.

Digital Orthopaedics’ ambition is to transform the planning and execution of orthopedic surgeries and treatment with the ultimate goal of personalizing orthopedic treatments through the innovative use of ideation, modeling and 3D simulation. The company lately got the CE Mark and is planning to commercialize its products in the coming 2 years.

The startup provides surgeons, patients, and medical devices companies with a state of the art CDSS to identify the optimal treatment and surgical therapeutic plan for each patient.  Digital Orthopaedics’ solutions also assist medical device companies with a mechanism of virtual clinical studies for testing implants and prosthetic ankles.

With a team of around 20 passionate persons, Digital Orthopaedics is dedicated to improving patients treatment and outcome. Since 2016, teams of engineers and physicians have been working closely together to generate highly innovative solutions and results.

As part of the development of Digital Orthopaedics’ activities, we are actively looking for a (m/f):

Chief Executive Officer (CEO)

Main responsibilities:

As a Chief Executive Officer, your main objective is to efficiently develop the company’s growth and to lead the development and commercial phases and actions. You successfully close new financing rounds and help Digital Orthopaedics become one of the top players in this market.

The position’s main responsibilities are:

  • Determine the company’s strategy and objectives on a commercial, financial, managerial and technical level, in consultation with the Board of Directors and the shareholders.
  • Promote and execute the strategy with a focus on adding value for shareholders.
  • Contribute to the definition of coherent and efficient go-to-market strategic and operational plan and play a major role in its execution.
  • Propose and implement a market segmentation and product launch strategy.
  • Develop a long term and a M&S portfolio strategy.
  • Identify relevant collaborations and partnerships, licensing deals and business opportunities.
  • Actively participate in the Board of Directors and chair the Executive Committee.
  • Promote and maintain positive relationships with all stakeholders.
Profile :
  • You have a Master’s degree or a PhD with a scientific, economic or commercial orientation. A MBA is an asset.
  • You have at least 10 years’ experience in management positions in business development.
  • You combine experience in successful start-up or early stage businesses with hands-on past experience at executive level in a healthcare/medtech business.
  • You have an entrepreneurial mindset, and a proven track record of success in helping build businesses from start-ups or small business units into sustainable commercial operations.
  • You take advantage of a well-connected professional network within the life sciences industry.
  • You have experience of successful launches of new technologies.
  • You fluently communicate in English and French.
Offer :
  • A challenging and leading position within a high-potential MedTech start-up.
  • To join a e-Health company with a worldwide ambition.
  • The opportunity to work in a human-sized, dynamic, respectful and professional environment.
  • An attractive package in line with the position responsibilities and its context.

Site Manager - Industry - Région de Charleroi

Notre client est une entreprise industrielle spécialisée en fabrication de pièces métalliques à destination des professionnels de la construction.

Située dans la région de Charleroi, la société est composée d’une vingtaine de collaborateurs passionnés et motivés. Notre client dispose de son propre parc de machines et met en œuvre un nouveau plan d’investissement pour renforcer son positionnement sur le marché pour les années à venir.

Afin de renforcer l’équipe, nous sommes à la recherche d’un (m/f) :

Site Manager

Responsabilités :

En tant que Site Manager, vous dirigez le site industriel alliant les activités de fabrication, de planification, d’achat, de maintenance et de vente. Vous faites vivre la vision et les valeurs du groupe, tout en respectant les spécificités et la valeur-ajoutée locale. En outre, vous assurez la qualité, la sécurité et l’amélioration continue des activités. Vous contribuez activement au développement commercial des activités.

Vos principales responsabilités sont les suivantes:

  • Gestion du développement commercial, et de la santé financière du site.
  • Coordonner et optimiser le fonctionnement des opérations, ainsi que des achats..
  • Diriger, motiver et développer les collaborateurs de l’équipe.
  • Mettre en œuvre la stratégie de l’entreprise au sein du site, et veiller à l’amélioration continue.
  • Garantir l’application des règles de sécurité, des normes de qualité et du règlement intérieur.
  • Rapporter de manière structurée, rigoureuse et adaptée les résultats des activités.
Profil :
  • Vous êtes titulaire d’un diplôme de Master, d’Ingénieur ou équivalent par expérience.
  • Vous disposez de 10 ans d’expérience dans une fonction comparable en environnement industriel
  • Vous communiquez efficacement, avec assertivité, et possédez une certaine aisance relationnelle.
  • Vous êtes à l’écoute et faite preuve d’empathie envers vos collaborateurs.
  • Vous faites preuve de leadership, et démontrez des compétences en change management.
  • Vous parlez couramment Français et avez une bonne maitrise de l’Anglais. La connaissance du Néerlandais est un atout.
  • Vous vous déplacez ponctuellement chez les fournisseurs et/ou clients.
Offre :
  • Une fonction diversifiée au sein d’une industrie reconnue pour la qualité de ses produits.
  • Des défis opérationnels, commerciaux et humains stimulants et enrichissants.
  • L’opportunité de développement et d’évolution en termes de responsabilités.
  • Un salaire attractif reprenant des avantages extra-légaux en phase avec votre expérience.

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42 resultaten

C/C++ Software Engineer - Engineering, Innovation, Transport - Genval

Founded in 2013, E2 Drives is an innovative start-up company active in electric mobility. The company is specialized in mechanics, electronics, electric motor and embedded control software. Recently, E2 Drives has developed a high-end and disruptive new generation of electric bikes. The key differentiator of the bike is its all-in-one drive unit integrating an electric assistance and an automatic gearbox.

E2 Drives’ ambition is to develop and commercialize the best electric bike on the market, in the commuting segment, with premium functions and an affordable price. The team is currently composed by 5 dynamic and entrepreneurial persons but will strongly grow this year.

E2 Drives, future top player of the electric bikes market, is based in Genval (South-East of Brussels).

In order to strengthen the team in Genval, we are looking for a (m/f):

C/C++ Software Engineer

Responsibilities:

Reporting to the CTO, you develop RTOS C++ embedded firmwares for the central IoT board of the innovative bikes. Based on market and testrides feedbacks, you identify and implement new solutions and technical upgrades.

Your main responsibilities are:
  • You propose and implement the roadmap of RTOS C++ embedded firmware of the central IoT board with focus on quality, robustness and timing.
  • You identify, propose, implement new and existing connected functions (including BLE, 3G, NB-IoT, GPS, NFC stacks).
  • You work in a broader way on the overall behaviour of the connected bike.
  • You test/debug and validation of technical upgrades.
  • You are in charge of your own projects and collaborate within the software development team.
  • You report work evolution on a regular basis.
Profile:
  • Master degree in engineering, IT, computer science, or equivalent through experience.
  • 3 to 5 years’ experience in a software engineer position within the industry.
  • Experience in C/C++ firmware development with RTOS, and several communication peripherals (BLE, 3G, NB-IoT, GPS, NFC…) and sensors from the IoT world. Familiar with Git.
  • Analytical, problem solving skills, rigorous, autonomous and results oriented.
  • Familiar with failure analysis and code robustification.
  • Command of bootloader, authentification, and encrypted firmware updates are a plus.
  • Knowledge in STM32 family peripherals is a plus.
  • Fluent in French or in English.
Offer:
  • A challenging position within a high-potential innovative start-up.
  • To join an electric bikes company with a worldwide ambition.
  • The opportunity to work in a human-sized, dynamic and excellence-oriented environment.
  • An attractive salary package in line with the position responsibilities and its context.
  • A full-time permanent contract.

Research Technician – In Vivo Pharmacology - Bio-Pharma/Biotech, Biotechnology - Gosselies

iTeos Therapeutics is a privately-held, clinical-stage biopharmaceutical company dedicated to extending and improving the lives of cancer patients by designing and developing next generation immunotherapies.

Based in Gosselies, Belgium and Cambridge, MA, iTeos Therapeutics was founded out of the Ludwig Institute for Cancer Research (LICR) and the de Duve Institute (UCLouvain) in 2011. In March 2020, the Company completed a $125 million Series B2 financing. For more information, please visit www.iteostherapeutics.com.

iTeos Therapeutics is now a world-class actor in the sector. To carry on its growth and reinforce its team, iTeos Therapeutics is looking for an (m/f) :

Research Technician – In Vivo Pharmacology

Keys responsibilities:

As a Research Technician, you perform in vivo assays to discover and to validate small molecules and biologics for the development of innovative cancer immunotherapies. Your main responsibilities are as follows :

  • Perform experimental in vivo models of cancer, including compound dosage and endpoint assessment, according to Standard Operating Procedures.
  • Perform pharmacokinetic and pharmacodynamics studies.
  • Systematically compile data and report in Excel and in Prism files.
  • Collaborate with other project stakeholders and discuss assays results with them.

This function requires occasional presence on Saturdays or Sundays (more or less once a month). The function may from time to time require starting work before 8am or ending the day between 5-7pm.

Profile:
  • Bachelor in Life Sciences, Pharmacology, Biochemistry or closely related field.
  • FELASA B/C certified.
  • Experience in in vivo studies is a must.
  • Previous experience in Culture of cell lines for in-vivo studies and/or standard lab techniques (ELISA, qPCR, flow cytometry, etc.) is a plus.
  • Previous experience in the biotech/pharma industry or in a similar academic position is an advantage.
  • Knowledge of Microsoft Office. Knowledge of Prism is a plus.
  • Good communication skills in French and English.
  • Rigorous, detail-oriented, organized, autonomous, committed and flexible.
  • Strong team spirit and excellent interpersonal skills.
Offer:
  • A stimulating scientific position within a high-potential innovative biotech company.
  • The opportunity to work in a science-driven, dynamic, human‐sized, respectful and professional environment.
  • A challenging scientific and business growth in which you get to bring your knowledge and skills.
  • Varied contacts inside the company, the biotech/pharma sector and the scientific world.
  • A long-term contract and an attractive salary package in line with the position responsibilities and your experience.

Maintenance & Manufacturing Technician - Medical Device - Awans (Liège)

Miracor Medical, a medical device company located in Awans, Belgium, provides innovative solutions for the treatment of severe cardiac diseases, aiming to improve short and long-term clinical outcomes and reduce associated cost.

The company has developed the PiCSO Impulse System, the first and only coronary sinus intervention designed to reduce infarct size, improve cardiac function by clearing microcirculation and potentially reduce the onset of heart failure following acute myocardial infarction.

The technology has received ‘Breakthrough Designation’ from the FDA in 2019 and the CE-Mark in June 2020. Miracor is currently recruiting patients in a landmark European randomized controlled trial, while preparing for a US investigational device exemption study (IDE) and building up team for the upcoming commercialization.

Miracor Medical is now looking for talented and enthusiastic talents to expand its international team. For additional information about the company and its technology, please visit www.miracormedical.com.

Miracor Medical offers a culturally diverse, English speaking working environment in the heart of Europe, Belgium, a few hours away from Europe’s capital cities.

To support the development of the company, we are looking for a (m/f):

Maintenance & Manufacturing Technician

The key objectives of the Maintenance & Manufacturing Engineer are to ensure that the System installation, service and repair activities are planned and carried out on time and that the production of Components is executed as planned. The position is office based in Awans (Liège). Travel to hospitals and other partnering companies in Europe is possible.

Responsibilities:
  • Contribute to the Company Quality Objectives
  • System installation, service and repair management and execution
  • Responsible for the manufacturing (packaging and labelling) of system components.
  • Test equipment management (e.g. monitor calibration needs).
  • Spare parts management (e.g. create technical specifications, perform purchasing and inspection tasks).
  • Assist in verification and validation activities.
  • Other duties as assigned by direct Supervisor

 

Profile:
  • Bachelor’s or master’s degree in Biomedical Sciences, or equivalent through experience.
  • Any experience as a technician or engineer in the Medical Device industry is an asset
  • You are autonomous and have a hands-on and pragmatic mind-set.
  • You are able to work and collaborate effectively with internal and external stakeholders to achieve company objectives.
  • You are able to understand and interpret medical device regulations and Quality Management Systems.
  • You possess excellent communication skills.
  • You would like to work in a dynamic and social environment.
  • You are fluent in English. A good command of French and/or any other language is an asset.
  • Proficiency with common business software, such as MS Office applications.

 

Offer:
  • A challenging and diversified position within a high-potential innovative medical device company.
  • To work in a human size, dynamic, respectful and professional environment.
  • International exposure, with learning and development opportunities.
  • An attractive compensation package in line with the position responsibilities and your experience.

Electric Motor control Engineer - Engineering, Innovation, Transport - Genval

Founded in 2013, E2 Drives is an innovative start-up company active in electric mobility. The company is specialized in mechanics, electronics, electric motor and embedded control software. Recently, E2 Drives has developed a high-end and disruptive new generation of electric bikes. The key differentiator of the bike is its all-in-one drive unit integrating an electric assistance and an automatic gearbox.

E2 Drives’ ambition is to develop and commercialize the best electric bike on the market, in the commuting segment, with premium functions and an affordable price. The team is currently composed by 5 dynamic and entrepreneurial persons but will strongly grow this year.

E2 Drives, future top player of the electric bikes market, is based in Genval (South-East of Brussels).

In order to strengthen the team in Genval, we are looking for a (m/f):

Electric Motor control Engineer

Responsibilities:

Reporting to the CTO, you develop embedded firmware for the motor control PCB. Based on internal objectives, you, on one hand, focus on tasks as improving motor control performance and on the other hand identify and implement more broader algorithm to control the whole drive unit of the electric bikes.

Your main responsibilities are:
  • You will propose and draw up the roadmap and its implementation in C of the electric motor control and more broadly the drive unit control.
  • You improve step response, improving efficiency, lowering ripples, increasing torque per ampere of our current PMSM FOC (also called dq, vector) control.
  • You adapt our control to IPM motor.
  • You lead C firmware developments, maintain, upgrade with regards to quality, robustness (by failure analysis) and timing.
  • You are in charge of your own projects and collaborate within the software development team.
  • You report work evolution on a regular basis.
Profile:
  • Master degree in engineering or equivalent through experience.
  • 3 to 5 years’ experience in a software engineer position within the industry.
  • Experience in time-critical C firmware development, PMSM and IPM control (FOC) and its low level constaints (Timing, Sampling, Filter delays, PWM updates opportunity…). Git or SVN familiar.
  • Analytical, problem solving skills, rigorous, autonomous and results oriented.
  • Familiar with failure analysis and code robustification.
  • Command of bootloader, authentification, and encrypted firmware updates are major assets.
  • Knowledge in STM32 and/or Kinetis families’ peripherals is a plus.
  • Fluent in French or in English.
Offer:
  • A diversified and challenging technical position within a experienced team in a fast growing start-up.
  • The opportunity to enter a sustainable development and green tech company.
  • Varied contacts with professionals on an international scale.
  • Significant learning and evolution opportunities.
  • An attractive salary package coherent with your experience.
  • A full-time permanent contract.

IT Application Manager - Radio–Pharma - Fleurus

Situées à Fleurus (Belgique), l’IRE et sa filiale IRE ELiT sont des entreprises industrielles renommées et innovantes jouissant d’un potentiel de développement élevé.

Avec près de 250 collaborateurs, l’IRE est l’un des principaux producteurs mondiaux de radio-isotopes utilisés en médecine nucléaire à des fins de diagnostic et de thérapie. IRE ELiT est quant à elle active dans la production radio-pharmaceutique.

Plus concrètement, ces entreprises contribuent à sauver des millions de vies dans le monde chaque année. Sur les 5 dernières années, l’entreprise a renforcé son développement et jouit d’une croissance continue. Pour plus d’informations, veuillez consulter www.ire.eu

Pour assurer le bon développement de l’IRE, nous sommes activement à la recherche d’un (m/f) :

IT Application Manager

Responsabilités :

Rapportant au Directeur des Opérations, vous supervisez et maintenez à jour les applications software en mettant en œuvre les bonnes pratiques. Vous assurez l’efficience des systèmes d’application, en optimisant les coûts et en garantissant un haut niveau de satisfaction des utilisateurs.

Vos principales responsabilités sont les suivantes :

  • Évaluer les besoins et requis de l’entreprise en solutions applicatives.
  • Mener le déploiement d’un nouvel ERP et son développement à travers toute l’entreprise.
  • Coordonner et mener à bien la digitalisation de l’entreprise.
  • Gérer le cycle de vie des applications et veiller à l’adéquation de la partie hardware.
  • Superviser le design, le développement et le déploiement des systèmes IT critiques.
  • Assurer la veille technologique, développer et optimiser des solutions.
  • Supporter la résolution de problèmes liés aux applications.
  • Créer et améliorer des processus et protocoles pour l’usage des applications. S’assurer que les bonnes pratiques et les standards soient appliqués.
Profil :
  • Vous êtes titulaire d’un Master à orientation IT.
  • Vous disposez de 10 années d’expérience, idéalement dans le secteur industriel/manufacturing, dont 3 ans dans un rôle de leadership.
  • Vous avez une expérience dans le déploiement d’un ERP et en gestion de projets transversaux.
  • Vous êtes orienté(e) solutions et résultats, et faites preuve d’assertivité et de diplomatie.
  • Rigoureux/se, pragmatique et autonome, vous êtes doté(e) d’une forte capacité organisationnelle et relationnelle.
  • Vous êtes capable de mobiliser les équipes, challenger le statu quo et d’exercer une influence sur l’organisation.
  • Vous jouissez d’une très bonne connaissance du français et de l’anglais.
Offre :
  • Une fonction diversifiée incluant des responsabilités et des projets intéressants.
  • Des défis professionnels, technologiques et humains enrichissants.
  • Intégrer une structure industrielle renommée et innovante en pleine croissance.
  • Un salaire attractif reprenant des avantages extra-légaux, en ligne avec votre expérience.

Research Scientist Translational medicine – Immuno-oncology - Bio-Pharma/Biotech - Gosselies

iTeos Therapeutics is a publicly-held (NASDAQ: ITOS), clinical-stage biopharmaceutical company dedicated to extending and improving the lives of cancer patients by designing and developing next generation immunotherapies. Based in Gosselies, Belgium and Cambridge, MA, iTeos Therapeutics was founded out of the Ludwig Institute for Cancer Research (LICR) and the de Duve Institute (UCLouvain) in 2011.  In March 2020, iTeos Therapeutics completed a $125 million Series B2 financing, and in July 2020, the company completed its IPO raising over $200million of proceeds.  This additional capital will allow the company to continue to develop its clinical pipeline and expand its preclinical pipeline by investing in the discovery research team.

iTeos Therapeutics’ innovative pipeline includes two clinical-stage programs targeting novel, validated immuno-oncology pathways. EOS-850, is designed as a highly selective small molecule antagonist of the adenosine A2a receptor, a key driver of immunosuppression in the tumor microenvironment across a broad range of tumors. EOS-850 is being investigated in an open-label Phase 1/2a clinical trial in adult patients with advanced solid tumors. The lead antibody product candidate, EOS-448, is an antagonist of TIGIT, also designed to engage the Fc gamma receptor, or FcγR,. An open-label Phase 1/2a clinical trial of EOS-448 is currently ongoing in adult patients with advanced solid tumors. iTeos Therapeutics also continues to expand its pipeline through internal research efforts and external collaboration with leading scientists.

For more information, please visit www.iteostherapeutics.com.

To reinforce its translational medicine team, iTeos Therapeutics is currently looking for a (m/f) :

Research Scientist

Translational medicine – Immuno-oncology

 

Responsibilities :

Within the Translational Medicine team, you will play a key role in the evaluation of the mechanisms of action of our immune oncology drugs in clinical development and support the selection of biomarkers. You will generate robust in vitro data on the products under clinical development, helping to interpret data obtained in clinical trials and refining our biomarker strategy.

Your main responsibilities will be to :

  • Coordinate with colleagues from the Translational Medicine or Pharmacology teams, design and perform independently complex experiments to assess the function and effect of iTeos drugs and to test new biomarkers in various immunology systems (i.e. immunophenotyping experiments, functional immunoassays as well as molecular biology and ELISA-based assays in human samples).
  • Identify and establish in the laboratory relevant immunoassays and technical approaches.
  • Compile, document, critically analyze experimental results in order to present them at project team meetings.
  • Show strong ownership by being up to date with the project literature and more broadly with the immune-oncology field.
  • Write technical reports and contribute to scientific articles.
  • Share your expertise e.g. in immunoassays with other people and other teams within the company.
  • Collaborate with external contacts, either with academic partners or with CRO’s.

 

Profile :
  • PhD and/or post-doc in (Tumour) Immunology.
  • Hands-on experience in the biotech/pharma industry would be valued and give you access to the Senior Scientist position.
  • Strong expertise in immunology techniques including functional immunoassays (e.g. in vitro stimulation of immune cells) and multi-parametric flow cytometry.
  • Strong background in molecular biology assays (such as qRT-PCR, NGS is a plus).
  • Previous experience in handling human blood samples and/or tissues for primary cell isolation is required.
  • Excellent command of English (oral and written), French is a plus.
  • Committed and detail-oriented, strong sense of time management and flexibility.
  • You are both autonomous and a team player with an inquisitive mindset and strong problem-solving skills.
  • You are very open-minded and have excellent interpersonal and communication skills.

 

Offer :
  • A stimulating position within a high-potential innovative biotech company.
  • The opportunity to work in a science-driven, dynamic, human‐sized, respectful and professional environment.
  • A challenging scientific and business growth in which you get to bring your knowledge and skills.
  • An extensive networking inside the company, the biotech/pharma sector and the scientific world.
  • A permanent contract with an attractive salary package in line with the position responsibilities and your experience.

R&D Engineer – Catheter - Medical Device - Awans (Liège)

Founded in 2009, CryoTherapeutics is an early stage European innovative company that is now establishing its operations in Liège (Awans). The company is in the process of developing a novel catheter system to treat atherosclerotic plaque that causes heart attacks by delivering cryoenergy to the coronary arteries. For additional information about the company, please visit http://www.cryotherapeutics.com/

CryoTherapeutics aims to develop and market the novel cryoenergy therapy initially for patients who have suffered a heart attack, and in the longer term also for patients identified as being at future risk of heart attack. CryoTherapeutics recently raised 7M€ in its latest round of financing and will use these funds to continue development of this technology with the aim of starting clinical studies later this year.

In order to support the expansion of the team in Awans, we are looking for a (m/f):

R&D Engineer – Catheter

Responsibilities:

As a R&D Engineer – Catheter, the candidate will lead and take care of designing, developing and testing next-generation catheter delivery systems from concept to human use. Reporting to the CTO you play a key role in the R&D/innovation activities.

The position’s main responsibilities are:

  • Conceptualize, design and develop innovative interventional catheters, including design requirements, prototype developments, pre-clinical and clinical assessments, and industrialization.
  • Support the design of the next generation catheter components, in collaboration with Quality.
  • Support the development of new test methods, tooling and equipment procurement, and executing long term testing for catheters.
  • Collaborate with colleagues and physicians in both pre-clinical and clinical developments in order to evaluate technology and to have a better understanding of cardiovascular anatomy.
  • Work with team members and external partners to deliver project’s technical objectives.
  • Report results and work evolution on a regular basis to the top management.
  • Establish timelines and ensures adherence to timely execution
  • Develop appropriate test methods for product evaluations, writes and executes test protocols and test reports required per GMP and regulatory submissions
Profile:
  • Mechanical or Biomedical Engineering Master’s degree.
  • First experience in design, development and industrialization within medical device companies.
  • Experience with catheters is a strong asset.
  • Relevant technical expertise on extrusion, braiding, molding, and bonding processes.
  • Experience in materials (plastics, adhesives and associated processes), and mechanical (small part) design is desired.
  • Experienced in medical device regulatory requirements, QMS and design control processes is an asset.
  • Proven record of working with and managing vendors for product and process specification and testing.
  • Strong innovation and communication skills together with hands-on and pragmatic mind-set.
  • Very good organizational, analytical and problem solving skills.
  • Highly collaborative, self-motivated and team-oriented individual in a company setting.
  • Excellent oral and written communication skills in English. Any other language is a plus.
  • Up to 25% travel may be required.
Offer:
  • A challenging position with a high potential innovative medical device company.
  • To work in a human-sized, collaborative and respectful environment
  • A variety of interesting contacts with international exposure.
  • An attractive compensation package in line with the position’s responsibilities and your experience.

Responsable Maintenance et Facilities - Radio–Pharma - Fleurus

Situées à Fleurus (Belgique), l’IRE et sa filiale IRE ELiT sont des entreprises industrielles renommées et innovantes jouissant d’un potentiel de développement élevé.

Avec près de 250 collaborateurs, l’IRE est l’un des principaux producteurs mondiaux de radio-isotopes utilisés en médecine nucléaire à des fins de diagnostic et de thérapie. IRE ELiT est quant à elle active dans la production radio-pharmaceutique.

Plus concrètement, ces entreprises contribuent à sauver des millions de vies dans le monde chaque année. Sur les 5 dernières années, l’entreprise a renforcé son développement et jouit d’une croissance continue. Pour plus d’informations, veuillez consulter www.ire.eu

Pour assurer le bon développement de l’IRE, nous sommes activement à la recherche d’un (m/f) :

Responsable Maintenance et Facilities

Responsabilités :

Rapportant au Directeur des Opérations, vous gérez et optimalisez les activités de maintenance de l’outil de production et de l’Infrastructure. Vous dirigez une équipe d’environ 30 personnes.

Les responsabilités suivantes vous sont confiées :

  • Définir et mettre en place la stratégie de la maintenance à moyen et long terme.
  • Élaborer, suivre et optimiser le budget de la maintenance des équipements.
  • Diriger, motiver et développer les collaborateurs du département.
  • Élaborer et implémenter la TPM au niveau de la maintenance.
  • Veiller aux indicateurs de performances et atteindre les niveaux de services attendus.
  • Déployer le programme de gestion de la maintenance (GMAO).
  • Promouvoir la dynamique d’amélioration continue au sein du département.
  • Être le point de contact technique avec les institutions externes.
  • Développer un partenariat avec la délégation syndicale.
Profil :
  • Vous êtes Ingénieur ou équivalent par expérience.
  • Vous disposez d’environ 10 années d’expérience dans une fonction comparable au sein d’un environnement industriel, de préférence en milieu pharmaceutique/biotech.
  • Vous appréciez les environnements industriels sous hautes contraintes de qualité.
  • Vous êtes orienté(e) solutions et faites preuve d’assertivité et de diplomatie.
  • Vous faite preuve de leadership et d’une forte capacité organisationnelle et relationnelle.
  • Vous jouissez d’une très bonne connaissance du français et de l’anglais.
  • Vous êtes orienté(e) résultats et solutions, rigoureux/se, pragmatique et autonome.
Offre :
  • Une fonction diversifiée incluant des responsabilités et des projets intéressants.
  • Des défis professionnels, techniques et humains enrichissants.
  • Intégrer une structure industrielle renommée et innovante en pleine croissance.
  • Un salaire attractif reprenant des avantages extra-légaux, en ligne avec votre expérience.

Quality Assurance and Regulatory Affairs Manager - Biotech, Biotechnology - Flémalle

Created in 2013, Wishbone is an innovative start-up located in Flemalle (Liege). Wishbone is engaged in the development of intraoral bone regeneration biomaterials. The company has launched its industrialization and production activities in a brand new production unit and has successfully reached ISO 13485 certification.

The goal of Wishbone is to develop superior bone graft substitute products with breakthrough technologies and innovative procedures, and thus improve patient well-being and contribute to a better environment. The company will launch its forst commercial product and several other innovative products are under development. For more information please visit: www.wishbone-biotech.com

To support this challenging development, we are looking for a (m/f):

Quality Assurance and Regulatory Affairs Manager

Responsibilities:

As a Quality Assurance and Regulatory Affairs Manager, you are responsible for managing the company Quality Management System and its related activities. You are also responsible for the Regulatory Affairs Management. You ensure the company and the products are compliant with the appropriate standards and regulations. You provide support in the Quality Management System maintenance and improvements. This includes the development of systems, policies/procedures and programs to ensure compliance with the EU and FDA regulations, ISO standards, and other international requirements.

You have a cross-functional role, directly manages a small team of QA/RA Associate and Product Specialist and interact with all departments and with the top management.

Your main responsibilities are :
  • Managing the Quality Management System according to the EU ISO 13485, the US FDA 21 CFR Part 820 and any other relevant regulatory requirements in accordance with the Quality Policy.
  • Ensuring that required processes of the Quality Management System (QMS) are documented, established, implemented and maintained.
  • Assuring that products have been supplied, manufactured, analyzed and released according to specifications and approved SOP’s and to appropriate standards and regulations.
  • Organizing and documenting the Management Review according to the company QMS. Recommending and driving improvement.
  • Performing supplier audits, internal and external audits and interacting with suppliers and customers to deal with non-conformities and drive continuous improvement.
  • Supporting activities for CE marking and FDA approval certification of products as well as maintaining the documentation up to date when changes to the product occur, dealing with notifications and amendments when required.
  • Managing materiovigilance activities including incident and post-market surveillance reporting.
  • Ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
  • Reporting to the management on the effectiveness of the Quality Management System and any need for improvement of the company organization.
Profile:
  • Scientific Master’s degree, or equivalent through experience.
  • At least 5 years of experience in QA management positions in the medical devices industry.
  • Strong understanding of regulations and guidelines governing medical devices (e.g. CFRs, ISO 13485, MDD, MDR).
  • Strong leadership, project management and communication skills together with hands-on and pragmatic mind-set.
  • Ability to work in a start-up environment where accuracy, accountability, quality, safety and timeliness are essential.
  • Highly collaborative, self-motivated and team-oriented individual in a company setting.
  • Excellent oral and written communication skills in French and English. 
Offer:
  • The opportunity to join an innovative medical device company, a fast-growing start-up environment where teamwork, results and patient care are very important.
  • A challenging and diversified position in a dynamic, young and nice
  • To work in a human size, respectful and professional environment.
  • An attractive compensation package in line with the position responsibilities and your experience.

Senior BD & Investment Manager – Life Sciences - Innovation, Life Science & Technology - Louvain-la-Neuve

Sopartec S.A. (www.sopartec.com) est la société de transfert de technologie de l’UCLouvain, membre du Louvain Technology Transfer Office (LTTO) et gestionnaire des fonds Vives.

Le LTTO (www.ltto.com) est le guichet unique du transfert de technologie à l’UCLouvain. Il couvre les différentes phases du processus (du laboratoire jusqu’au marché) : financement des contrats de recherche ; détection d’inventions au sein des laboratoires; protection, gestion de la propriété intellectuelle et maturation technologique ; commercialisation via contrats de licence ou création de spin-offs.

Vives (www.vivesfund.com) sont des fonds de capital d’amorçage, gérés par Sopartec et initiés par l’UCLouvain, qui investissent dans des sociétés développant des innovations de rupture ayant un impact sociétal positif.

Le 3ème fonds, VIVES Inter University Fund, en cours de finalisation, investira dans les spin-off de l’UCLouvain ainsi que dans des projets provenant de ses partenaires académiques privilégiés (KUL, WUR, UNI et Université de Paris) dans un rayon de 400km autour de Louvain-la-Neuve.

Afin de renforcer l’équipe de Sopartec, nous sommes à la recherche d’un(e) (m/f) :

Senior BD & Investment Manager – Life Sciences

Responsabilités :

Rapportant au CEO, vous accompagnez les porteurs de projets dans la phase de maturation et de commercialisation du transfert de technologie et vous participez au processus d’investissement de VIVES dans le secteur des sciences de la vie.

Vos principales responsabilités sont :

  • Recherche, sélection et analyse d’opportunités d’investissement pour Vives Inter-University Fund : initiation et supervision de la phase de due diligence, négociation et préparation de propositions d’investissement, suivi administratif, juridique et financier des participations.
  • Représentation de la SOPARTEC/VIVES au sein du conseil d’administration des sociétés prises en participation.
  • Accompagnement des porteurs de projet dans les phases de maturation technologique et de commercialisation au sein du LTTO : participation à la stratégie de protection de la propriété intellectuelle, à l’élaboration des demandes de financement de la preuve de concept, à l’identification et à la validation du business model, à la recherche de parrainages industriels, au montage de la spin-off et à la valorisation de la propriété intellectuelle sous forme d’accord de licence.
Profil :
  • PhD ou Master en sciences du vivant : Pharma-, Bio- ou Chimie.
  • Une expérience de minimum de 10 ans en business development en milieu industriel ou en start-up est requise. Une expérience en brevet et en négociation des licences est un atout.
  • Intérêt marqué pour l’entrepreneuriat et pour les aspects stratégiques, financiers, juridiques et commerciaux.
  • Capacité de juger rapidement des mérites d’un projet.
  • Capable de trouver des solutions dans un environnement complexe et changeant.
  • Très bonne connaissance du français et de l’anglais, idéalement, du néerlandais.
  • Aisance relationnelle, compétences de négociation et sens aigu de la diplomatie.
  • Rigoureux, analytique, organisé, responsable et autonome.
Offre :
  • Une fonction riche et variée au sein d’une équipe dynamique et pluridisciplinaire.
  • L’occasion de contribuer activement au transfert des connaissances qui créeront du bien-être pour la collectivité et de la valeur ajoutée pour l’économie réelle.
  • Une culture de travail favorisant à la fois l’autonomie et le travail en team.
  • Un salaire attractif assorti d’avantages extra-légaux, en phase avec votre expérience.