Jobs

Geef uw doelstellingen aan help uw loopbaan sneller vooruit.

Biotechnology

5 resultaten

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.

Clinical Trial Assistant (CTA) - 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 a (m/f) :

Clinical Trial Assistant (CTA)

Main responsibilities:

iTeos Therapeutics is searching for a resourceful colleague that will be responsible for ensuring administrative support to the Gosselies-based Clinical management team. This position will function under the guidance and direction of the medical director. The successful candidate will be an autonomous and proactive with experience working in a clinical development environment.

More specifically, the responsibilities will be to :

  • Assist in the formatting, editing and processing of essential clinical documents (protocols, IB, reports, etc) for performance planning and accomplishments of Clinical staff. Keep publication lists, training records and curricula vitae of staff up to date.
  • Provide all necessary ad hoc help to make sure the clinical pharmacological studies can be carried out in a correct and timely way. In the absence of the study monitors, take the necessary initiative to respond to requests from study sites.
  • Filing: ensure that all administrative and research-related documents are filed correctly and timely. Make sure that all documents can be traced at any time for internal and external use and/or audits.
  • Continuous improvement: constantly assesses internal administration procedures and proposes alternatives for better functioning to the study monitors and to the management. Informs the management of possible issues.
  • Typing, redaction, translation: where necessary, type, write and/or translate documents for internal and/or external use.
  • Provide general support to the Directors and Managers: e.g. deal with general correspondence, manage files, type and prepare presentations, organize business travel, organize and participate in and write minutes of staff meetings, prepare expense reports, manage vacation schedule …
  • Agenda management: follow-up on agenda of local management and ensure that the communication flow between study monitors, local and US management and study sites is optimized.
  • Financial routine: invoices and supply management.
Profile:
  • Bachelor or Master degree with a first experience in a comparable position.
  • Written and spoken fluency in English and French.
  • Excellent computer skills – MS office.
  • Communication and organization skills.
  • Very high accuracy.
  • Flexibility and hands-on initiative.
  • Sense of responsibility.
  • Basic knowledge of medical terminology is an asset.
  • Capacity to work autonomously and in a team.
  • Eager to learn.
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.
  • Varied contacts inside and outside the company.
  • A long-term contract and an attractive salary package in line with the position responsibilities and your experience.

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.

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.

Finance Manager Belgium & Group Internal Controller - 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) :

Finance Manager Belgium & Group Internal Controller

Reporting to the US based Finance Director, you are responsible for the overall supervision of all Belgian day-to-day financial activities (including external consultants) and in charge, with the support of external consultants, of the group internal controls.

Main responsibilities:

External reporting

  • Preparation of quarterly and annual US GAAP consolidated accounts (with external consultants)
  • Management of the relationship with external auditors and financial consultants
  • Preparation of the Audit Committee

Budgeting, financial reporting and controlling

  • Supervision of financial book-keeping and external accountants
  • In charge of cost/management accounting
  • Preparation of budgets & plans and monthly, quarterly & annual reporting.
  • Follow-up of expenses and in particular projects or activities related costs, in coordination with the scientific and clinical teams.
  • Identification and analysis of significant gaps between budget and actuals.
  • Forecasts and specific financial analysis requested by top management
  • Presentation to and review of financial position with top management

Tools, systems and procedures

  • Define, implement and maintain adequate internal controls (Sox compliance is foreseen in the future)
  • Selection, implementation & maintenance of accounting and ERP systems
  • Review, development, optimization and implementation of accounting procedures

Taxes

  • Follow up of transfer pricing policy and associated documentation (with external advisors)
  • Follow up of Belgian tax position (with external advisors)

Treasury

  • Treasury forecast, FX risk management
  • payments management.

Support to specific projects such as IPO preparation, Sox implementation and follow-up, etc.

Profile:
  • You hold a University Degree (Master degree in economics, finance or related).
  • You have at least 5 years’ experience in controlling and reporting activities (in the Life sciences sector is a plus). Your latest experience involves internal controls in, ideally, a Sox environment.
  • Demonstrated accomplishments in areas of financial analysis/reporting, budgeting, internal controls, auditing, working capital and cash flow management, forecasting & consolidated reporting, risk assessment and continuous improvement.
  • You have good knowledge of IFRS and/or US GAAP standards.
  • You master Standard Office tools and BOB (or other accounting software) and you are familiar with ERP.
  • You are perfectly fluent in French and English (oral and written).
  • You are willing to travel to the U.S. (possible travels to Boston).
  • Organized and rigorous, you have a good ability to adapt to changes in priorities.
  • Although autonomous, you have a high ability to collaborate with multidisciplinary teams.
  • You are very open-minded and have excellent interpersonal and communication skills.

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.

Andere loopbaanmogelijkheden

39 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.

Quality Assurance Manager – Product release and Regulatory Affairs - Pharmaceutical - Gosselies

Novasep est l’un des principaux CDMO au service des sciences de la vie et de la chimie. L’entreprise propose une large gamme de services : développement de procédés, d’équipements et de systèmes de purification de molécules, ainsi que des services de fabrication. Pour plus d’informations : http://www.novasep.com

Novasep Belgium est l’un des leaders mondiaux dans la production de vecteurs viraux. Situés à Seneffe et Gosselies, ses deux sites offrent un environnement de travail stimulant et convivial. Novasep Belgium compte près de 250 collaborateurs, et met actuellement en place un plan de croissance ambitieux et structuré.

Afin de soutenir le développement de Novasep Belgium, nous sommes à la recherche d’un (h/f) :

Quality Assurance Manager – Product release and Regulatory Affairs

Responsabilités :

En tant que Quality Assurance Manager – Product release and Regulatory Affairs, vous êtes en charge de la libération des lots. Vous coordonnez les activités liées aux affaires réglementaires et aux audits internes. Vous accompagnez et supervisez les équipes de votre département. Vous avez un rôle de Qualified Person.

Vos responsabilités principales sont :

  • S’assurer que les exigences pour libérer un lot soient respectées (directive 2003/94/EC pour les produits médicaux).
  • Piloter les activités de libération des produits.
  • Mener les audits internes dans le respect des procédures LEAN.
  • Implémenter et maintenir un système réglementaire efficace qui s’applique à toutes les activités de Novasep.
  • Diriger les activités de validation en assurant des procédures LEAN.
  • Tenir à jour les procédures, instructions et autres documents de support.
  • Former le personnel aux techniques de production.
  • Accompagner, former et superviser les équipes
  • Superviser les équipes : Animer – Contribuer – Coacher – Diriger.
  • S’inscrire dans une démarche d’amélioration continue en vue d’optimiser les pratiques.
Profil :
  • Vous avez un diplôme de Pharmacien Industriel et avez obtenu l’agrément de Qualified Person.
  • Vous possédez au moins 5 années d’expérience dans un département Qualité au sein d’une entreprise pharmaceutique. Vous avez 2 ans d’expérience dans un rôle de QP.
  • Vous avez une bonne expérience en gestion d’équipe.
  • Vous avez de bonnes connaisses des normes cGMP et FDA concernant la fabrication, les essais et la libération des produits.
  • Vous avez de l’expérience avec la méthodologie LEAN.
  • Vous vous exprimez aisément en Français et en Anglais.
Offre :
  • Une fonction diversifiée comprenant de nombreuses responsabilités.
  • L’opportunité de rejoindre un leader mondial, reconnu pour son expertise.
  • Travailler dans un environnement convivial, avec des collègues passionnés et motivés.
  • Un contrat à temps plein et à durée indéterminée, assorti d’un package salarial adapté à votre profil et à votre niveau d’expérience.

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.

Qualified Person (QP) - Pharmaceutical - Gosselies

Novasep est l’un des principaux CDMO au service des sciences de la vie et de la chimie. L’entreprise propose une large gamme de services : développement de procédés, d’équipements et de systèmes de purification de molécules, ainsi que des services de fabrication. Pour plus d’informations : http://www.novasep.com

Novasep Belgium est l’un des leaders mondiaux dans la production de vecteurs viraux. Situés à Seneffe et Gosselies, ses deux sites offrent un environnement de travail stimulant et convivial. Novasep Belgium compte près de 250 collaborateurs, et met actuellement en place un plan de croissance ambitieux et structuré.

Afin de soutenir le développement de Novasep Belgium, nous sommes à la recherche d’un (h/f) :

Qualified Person (QP)

Responsabilités :

Rapportant au QA Manager, vous êtes responsable de la libération finale des lots de produits pharmaceutiques.

Vos responsabilités principales sont :

  • S’assurer que les exigences pour libérer un lot soient respectées (directive 2003/94/EC pour les produits médicaux).
  • Garantir que les procédures de production et de test ont bien été validées.
  • Vérifier que les contrôles de qualité ont été menés adéquatement concernant les conditions de production et d’emballage des lots.
  • Veiller à ce que tous les tests et vérifications soient effectués en cas de déviation ou de changement dans la production.
  • Valider que la documentation relative à la production, aux emballages, au contrôle de qualité est bien complète et validée par une autorité compétente.
  • S’assurer que les prescriptions légales sont respectées pour les produits importés.
  • Veiller à ce que les conditions générales liées aux licences de production et autorisations de production (IMB) soient bien appliquées.
  • Mener des audits GMP dans les sites de production de produits médicaux utilisés pour les études cliniques.
  • Tenir un registre des lots validés.
  • Promouvoir les normes GMP à l’aide de formations et d’accompagnements en interne.
Profil :
  • Vous avez un diplôme de Pharmacien Industriel et avez obtenu l’agrément de Qualified Person.
  • Vous avez au moins 5 années d’expérience en assurance qualité.
  • Vous êtes reconnu(e) pour votre rigueur, votre assertivité et votre esprit de synthèse.
  • Vous vous exprimez aisément en Français et en Anglais.
Offre :
  • Une fonction diversifiée comprenant de nombreuses responsabilités.
  • L’opportunité de rejoindre un leader mondial, reconnu pour son expertise.
  • Travailler dans un environnement convivial, avec des collègues passionnés et motivés.
  • Un contrat à temps plein et à durée indéterminée, assorti d’un package salarial adapté à votre profil et à votre niveau d’expérience.

Dessinateur/Projeteur - Aéronautique - Bernissart

Fondée en 2009, JDC Airports est une société spécialisée dans l’intégration de systèmes « Aeronautical Ground Lights ». Leurs sièges opérationnels se trouvent à Harchies, Bernissart (Belgique) et Roissy (France).

Avec près de 70 collaborateurs, JDC Airports est l’un des leaders et un expert dans le balisage aéroportuaire. Leur offre s’étend depuis la conception (bureau d’études) jusqu’à la réalisation et la maintenance des installations.

La politique de JDC Airports est orientée sur le dynamisme et le service à la clientèle, tant au niveau national qu’international. Notre client propose une structure compacte, un personnel expérimenté et certifié. Pour plus d’informations, veuillez consulter www.jdc-airports.com

Afin de soutenir la croissance de JDC Airports sur son site à Bernissart (près de Mons, Belgique), nous sommes à la recherche d’un (h/f) :

Dessinateur/Projeteur

Responsabilités :

En tant que Dessinateur/Projeteur en Electricité, en lien direct avec les Responsables d’Affaires et les Conducteurs de travaux, vous aurez en charge les études techniques. Vous établissez des plans et schémas électriques, des calculs d’éclairement et divers autres projets clients.

Vos responsabilités principales sont :
  • Réaliser des schémas et des plans électriques.
  • Gérer des dossiers d’exécution et des ouvrages exécutés.
  • Réaliser des relevés et métrés pour la réalisation des plans.
  • S’occuper du dimensionnement des réseaux (note de calculs BT).
  • Etablir des calculs d’éclairement (intérieurs et éclairage public).
  • Mener des études techniques des projets d’appel d’offre Balisage lumineux ou Tertiaire.
Profil :
  • Vous possédez un diplôme technique A2/A3 en électromécanique ou électricité.
  • Vous présentez une première expérience réussie dans un poste similaire.
  • Vous êtes autonome, rigoureux/se, organisé(e).
  • Vous êtes doté(e) d’un bon esprit de synthèse et une bonne capacité d’adaptation.
  • Vous maitrisez AutoCAD et les logiciels de bureautique (Word, Excel).
  • La connaissance des logiciels de calculs Caneco et DiaLUX, ainsi qu’une bonne connaissance technique des normes C15-100 et C13-100 est un plus.
Offre :
  • L’opportunité de rejoindre une société dynamique et en pleine croissance.
  • Une fonction technique, proche du terrain.
  • Un contrat à durée indéterminée assorti d’une rémunération attractive ainsi que des avantages liés à votre fonction.

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.

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.

Software Engineer - Green Technologies, Green-Tech - Liège

Based in Liège, SmartNodes is the LACROIX City R&D excellence center for smart street solutions over lighting grids. The measurement of traffic density and user speeds is used for road mobility and safety applications.  By integrating environmental sensors, parking sensors, etc., SmartNodes’ public lighting network is becoming the driving force behind Smart street networks.

SmartNodes is part of LACROIX City, European leader in Smart City technology. As industrial designer of complementary smart street equipment for local authorities and businesses, LACROIX City guides, optimizes and secures the flow of vehicles and people with an end goal: to share streets and roads, taking into account the needs of all their users and operators. Established in France, Spain, Belgium and North America, LACROIX City has now more than 600 employees shared between R&D offices and complementary production sites. Lacroix City customers are cities, regions and distribution network companies, worldwide. Together, they prepare the infrastructure for smart roads and mobility. Please visit https://www.lacroix-city.com

In order to develop its business and reinforce the team in Liège, we are actively looking for a (m/f):

Software Engineer

Responsibilities:

Reporting to the R&D Manager, you are developing backend applications and SmartNodes embedded communication technologies. You maintain close contact with Sales & Marketing in order to identify technical upgrade of current solutions and commercial opportunities.

Your main responsibilities are:

  • You propose, with the support of the R&D Manager, the roadmap of backend and embedded applications.
  • You develop, maintain and upgrade backend and embedded applications and/or you customize existing standard applications to the most suitable solution based on the customers’ specifications and expectations.
  • You participate to demonstrations and software development projects.
  • Your report work evolution on regular basis.
Profile:
  • Master degree in engineering, IT or computer science, or equivalent through experience.
  • Good understanding of Linux environments and embedded C.
  • Solutions, quality, innovation and results oriented, with good communication skills.
  • Self-motivated, team player, hands on, autonomous, rigorous and flexible.
  • Very good command of English.
  • The command of French, Dutch and/or German is a plus.
  • Junior application welcome.
Offer:
  • A diversified and challenging technical position within a dynamic team in a leader company.
  • 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.

Project Leader en microbiologie cutanée - Life Sciences, R&D Medical & Science - Gembloux

Basée à Gembloux (Belgique), StratiCELL est une entreprise supportant la recherche et le développement de produits à usage cutanés, en cosmétique et en dermatologie. La CRO (Contract Research Organisation) a pour mission d’objectiver l’effet de principes actifs sur base de modèles cellulaires et tissulaires.

StratiCELL fait partie du groupe Plant Advanced Technologies (Alternext, Paris) et jouit depuis 15 années d’une excellente réputation au niveau mondial. L’équipe actuelle, composée de 12 scientifiques passionnés, apporte son expertise scientifique aux clients de l’entreprise, les leaders du marché dermo-cosmétique.

La R&D représente une partie importante des activités de StratiCELL et alimente continuellement le pipeline de modèles et de tests, ciblés sur les pathologies de la peau (humaines et vétérinaires), la neuro-dermatologie, ou encore sur l’étude des interactions peau-microorganismes.

Afin de soutenir la croissance de son département microbiote cutané, nous sommes à la recherche d’un (h/f) :

Project Leader en microbiologie cutanée

Responsabilités :

Rapportant au CEO, vous êtes responsable du développement du département de microbiologie cutanée et des projets associés. En tant qu’expert, vous êtes le point de contact principal pour les clients et les collègues sur les questions liées à la microbiologie cutanée.

Vos principales responsabilités sont les suivantes :

  • Développer des projets intégrant des composants du microbiote cutané aux modèles 3D de peau in vitro.
  • Mettre au point des tests dermo-cosmétiques pertinents basés sur les interactions peau-microbiote.
  • Conduire les projets de recherche au sein du département pour les clients et la R&D.
  • Développer l’activité en capitalisant sur les connaissances et les modèles déjà acquis.
  • Être la personne de référence sur les questions liées à l’étude du microbiote cutané.
  • Réaliser les mises au point et les études au laboratoire afin de développer les différents modèles.
  • Traduire les protocoles validés en offres d’essais standardisés pour les clients.
  • Supporter la personne en charge du business développement au niveau scientifique en répondant aux demandes des clients, par une veille sur le marché, et lors de conférences.
  • Réaliser le reporting en interne et en externe vers les organismes de financement.
Profil :
  • Vous êtes titulaire d’un Master ou d’un Doctorat en Biologie/Microbiologie avec une double compétence dans ces matières
  • Vous possédez une expérience en biologie de la peau et êtes familier avec le microbiote cutané.
  • Vous maîtrisez les techniques de culture cellulaire, histologie, immunomarquages, ELISA, qPCR, et les techniques de culture et d’identification de microorganismes (CFU, qPCR 16S, métagénomique, etc.)
  • Vous aspirez à travailler principalement au laboratoire, sous contraintes de biosécurité BL2.
  • Vous êtes capable de prendre le lead de projets et vous respectez les deadlines.
  • Vous avez des qualités relationnelles et de leader, et vous êtes de nature proactive.
  • Vos qualités sont la rigueur, la précision, la persévérance, la créativité et la communication.
  • Vous parlez couramment anglais, et êtes prêt(e) à vous déplacer ponctuellement à l’étranger.
Offre :
  • Un environnement stimulant et participatif au sein d’une PME de haute technologie, en forte croissance, leader en Europe des tests in vitro en cosmétique et dermopharmacie.
  • Un salaire en rapport avec l’expérience, et avantages extra-légaux.
  • Le support et l’expertise des scientifiques et d’une organisation à la pointe de l’innovation.

Principal Scientist - CRO, R&D Medical & Science - Gosselies

Caprion Biosciences, an international contract research organisation based in Montreal (Canada) offers analytical services to biopharmaceutical companies for the characterization of the human immune response in pre-clinical and clinical studies.

Caprion operates globally, with facilities in North America, Europe and Asia, and supports large pharmaceutical companies and biotechs.

In the context of its growing immune monitoring service offering, Caprion is looking to hire a Principal Scientist for its flow cytometry and serology platforms, for its site in Gosselies, Belgium.

Principal Scientist

Function :

Reporting to the Associate Director, Scientific Operations, and working closely with the laboratory personnel, the Principal Scientist will work within a team focusing on the characterization of the cellular and humoral immune response, using various types of assays such as flow cytometry (phenotyping, receptor occupancy, phosflow, ICS, etc) ELISPOT, ELISA, and viral neutralization tests.

Responsibilities include:

  • Overseeing experimental design of flow cytometry, ELISPOT and antibody-based assays through generation of study-specific workplans and supporting documentation;
  • Overall conduct of studies in different immune-therapeutic areas, acting as primary contact to the client for communication of study progress;
  • Ensures that timelines and milestones are met and are in line with company objectives;
  • Data interpretation, report generation and presentation of results to clients.
Profile of the applicant:

The applicant must hold a doctorate degree in life science, with strong knowledge of immunology, and preferably with post-doctoral experience (or equivalent).  Experience in the industry is a strong asset.

The applicant must :

  • Demonstrate excellent communication and organisational skills;
  • Be abreast of latest immune monitoring methodologies;
  • Have an excellent knowledge and understanding of GCLP regulations and other regulatory guidelines sufficient to carry out GCLP regulated studies and apply good documentation practices (GDP);
  • Experience in assay validation is an asset;
  • Be proficient with analysis software;
  • Be fluent in English (written & spoken) and able to functionally communicate in French;
  • Be willing to travel mainly within Europe and occasionally to other continents.
Offer :
  • Full time permanent contract, with possibility of rapid start.
  • Diversified tasks and responsibilities.
  • A professional, dynamic and stimulating work environment.
  • Training and development opportunities.
  • A competitive salary package including benefits, adapted to your experience and the context.