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R&D Medical & Science

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Research Assistant – Immunology / Serology (Laboratory work) - 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 Research Assistant for its flow cytometry and serology platforms, for its site in Gosselies, Belgium.

Research Assistant  – Immunology / Serology  (Laboratory work)

Function :

Reporting to the Laboratory Team Leader and working closely with Principal Scientists, the Research Assistant will work within a team focusing on the characterization of the cellular and of the humoral immune response. The main responsibilities will include the execution of PBMC isolation, flow cytometry assays, viral neutralization assays, Luminex and ELISA assays.

Tasks include :

  • Perform PBMC isolations, cellular assays, viral neutralization assays and other serological assays according to current standard operating procedures;
  • Establishment and maintenance of cell cultures;
  • Manage reagents inventories and orders;
  • Participate to the review of method SOP and worksheets;
  • Participate to the technical management of the laboratory;
  • Perform work according to internal quality standards, apply relevant Quality System procedures and participate to the continuous improvement of Quality documents;
  • Attend relevant internal training activities.
Profile of the applicant :

The applicant must hold a bachelor degree (or the equivalent) in a life science discipline such as biology, medical biology or biochemistry/biotechnology. One or two years of demonstrated experience in techniques related to cellular and humoral immunology is preferred.

The applicant must :

  • Demonstrate excellent organisational skills.
  • Demonstrate schedule adaptability and flexibility.
  • Be willing to actively participate to the generation, the implementation and the continuous improvement of laboratory processes.
  • Be willing to work in a Quality environment (ISO17025, GCLP, GMP) and apply good documentation procedures (GDP).
  • Be functional in French (spoken and written) and have a functional knowledge of written English. Knowledge spoken English is an asset.
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.

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.

Autres opportunités de carrière

37 résultats

Research Associate – Cellular Assays Immuno-oncology - Biotech - Gosselies

ImmunXperts is a high-potential start-up based in Gosselies, Belgium. This fast-growing company offers a wide range of Immunology services with a strong commitment to developing customized solutions for its clients.

The offerings include in vitro assays to assess the immunogenic potential of test molecules using T cell activation and proliferation assays as a surrogate marker for the induction of Anti-Drug-Antibodies. On the immuno-oncology side, ImmunXperts develops in vitro assays to assess the functionality of candidates. ImmunXperts continuously develops new cellular immune-assays to assist biotech and pharma companies directly in their product development. Other such collaborative services include protocol optimization and in-house training. More info can be found on www.immunxperts.com.

ImmunXperts’ team works in an open-minded, science-driven and fast-paced environment. In order to support their growth, ImmunXperts is actively looking to fill the following role (m/f):

Research Associate – Cellular Assays Immuno-oncology

As Research Associate, you will work closely with a growing team of Research Associates and lab technicians. Primarily, the immune-oncology cellular assay team to conduct, optimize and validate a wide variety of existing and new functional assays and help our clients characterize their therapeutic candidates. In function of the projects, you will also work with the other teams focusing on other immunological applications. Based on specific customer requests, you will need to employ your expertise in immunology, your analytical thinking and your problem-solving skills to design, test and confirm novel routes of predictive testing.

Key responsibilities
  • Perform cellular assays according to the Standard Operation Procedures
  • Participate in the development and optimization of cellular assays
  • Analyze data and write technical and scientific reports
  • Plan and organize your daily, weekly and monthly projects in coordination with the team to ensure delivery on budget and on time
  • Guide, train and support laboratory technicians to ensure quality work is delivered as planned
  • Support the sales and business development team in drafting and reviewing project proposals
  • Plan, coordinate and oversee progress of assigned projects intervening where necessary to stay on track
  • Manage suppliers, partners and subcontractors to ensure their roles are completed as expected
  • Report internally and externally (to client) on project progress and results
  • Respond to client inquiries and identify new project opportunities with returning clients
  • Reinforce and implement quality standards through continuous improvement strategies
  • Participate in conferences and review literature to stay up to date on progress in the field
  • Prepare and deliver technical and scientific presentations (talks, posters and webinars)
Experience
  • Master in Immunology, Biology, Pharmaceutical Science, or equivalent by experience
  • Experience working with primary cells
  • Hands-on expertise with cellular assays and immunological techniques, including flow cytometry. HTRF, Luminex and ELISpot are a plus
  • Strong grasp of assay development, validation and optimization methods
  • Previous work in direct contact with customers and service providers is a plus
Profile
  • 2 to 3 years’ experience in the pharmaceutical industry, biotech or CROs
  • Passionate and self-motivated Research Associate with ability to adapt to changing conditions
  • Excellent communication and organizational skills
  • Studious with attention to detail
  • Commitment to customer satisfaction
  • Comfortable working under pressure and with tight deadlines
  • Focus on quality and continuous improvement
  • Enjoys working in small teams and shaping the evolution of the company
  • Good English (written and spoken) skills

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.

Senior R&D Director - Medical Device - Belgium

Our client is a high-potential MedTech start-up company based in Belgium. They develop high-end innovative and disruptive therapies aiming to improve and save patients’ lives. The Company is financially backed by strong international investors and shows great business ambition.

In order to lead strategic R&D projects critical to the Company, we are looking for a (m/f):

Senior R&D Director


Responsibilities:

As a Senior R&D Director, you lead strategic R&D projects, especially in soft- and hardware components. Reporting to the CEO, and as a member of the Management Executive Committee, you lead innovation within the Company.

Your main responsibilities are:

  • You lead strategic R&D projects from a to z: specifications, design, prototype, industrialisation, manufacturing, and commercial release.
  • You ensure resources, processes, procedures and controls are adapted to the projects’ needs.
  • You lead internal and external project teams with respect to timelines, budgets, quality, safety and business requirements.
  • You analyze the market, select, lead and manage suppliers, vendors, contractors and external partners in order to meet the innovation goals.
  • You take account of medical safety requirements, FMEA and risk analysis. You prepare validation plans in line with company documentation, CE and FDA requirements and industry standards.
  • You lead development and manufacturing activities in compliance to the Quality Management Systems (ISO 13485 environment).
  • You are a key person of contact for KOL, scientific experts and governmental authorities.
  • You report results and work evolution on a regular basis to the top management.
  • You assist the CEO in representing the Company to internal and external stakeholders.
Profile:
  • Engineering Master’s degree or PhD in Electronics, IT or related fields.
  • 10 years’ experience in R&D positions within MedTech companies.
  • Expertise in hard- and software technologies.
  • Excellent project management methodologies and tools.
  • Strong leadership and communication skills 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.
  • You are likely to travel up to 20% of your work time.
  • Despite joining at senior level, you are a hands-on person and can lead and manage the team as well as perform some of the work at task.
Offer:
  • A leading and challenging position within a high-potential innovative MedTech.
  • To work in a human size, dynamic, respectful and professional environment.
  • International exposure, with development and evolution opportunities.
  • Varied contacts through external collaborations and partnerships.
  • An attractive salary package in line with the responsibilities and your experience.

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.

Assistant(e) Comptable et Administratif(ve) - Engineering, Innovation, Transport - Liège

Notre client est une start-up belge innovante basée à Liège. Son équipe, composée d’une vingtaine de personnes, est professionnelle, agréable et dynamique. La start-up est soutenue par d’importants investisseurs internationaux et possède un fort potentiel sur le marché.

Afin de poursuivre sa croissance, notre client recrute un(e):

Assistant(e) Comptable et Administratif(ve)

Responsabilités :

En tant qu’Assistant(e) Comptable et Administratif(ve), vous supportez les démarches comptables et administratives de la société. Rapportant au Finance Manager, vos principales responsabilités sont les suivantes :

  • Gestion des procédures comptables applicables au sein de la société: encodage de factures, notes de crédit, dépenses, etc.
  • Gestion des extraits bancaires et des affectations électroniques.
  • Gestion et suivi des fournisseurs d’un point de vue comptable.
  • Gestion de la documentation et des procédures administratives et juridiques de base (réponses à demandes d’informations, relecture et analyse de contrats, suivi auprès du secrétariat social…).
  • Supervision et coordination des procédures administratives : suivi et validation des chèques-repas, gestion des temps de travail (relations avec le secrétariat social).
  • Aide à l’organisation et planification de réunions, évènements, rendez-vous ou déplacements.
  • Assistance au management dans des tâches administratives, RH, ou comptables.
Profil :
  • Vous disposez d’un Bachelier en Comptabilité, Assistant de direction, Gestion d’entreprise ou bénéficiez d’expérience similaire probante.
  • Vous avez une réelle motivation pour l’encodage des documents comptables. Disposer d’une expérience avec un ERP et avec les tâches administratives est un plus.
  • Vous maîtrisez le français, et possédez un bon niveau d’anglais (écrit et oral).
  • Vous avez d’excellentes capacités relationnelles, rédactionnelles et communicationnelles.
  • Vous êtes rigoureux/se, organisé(e) et vous planifiez adéquatement votre travail et vos priorités.
  • Vous faites montre d’une bonne résistance au stress, d’une forte autonomie et de flexibilité. Vous être responsable, dynamique, proactif(ve) et pragmatique.
  • Vous êtes volontaire et êtes capable de travailler en équipe.
  • Vous maitrisez la suite MS Office (word, excel, outlook).

Offre :

  • Une fonction diversifiée au sein d’une start-up en forte croissance.
  • L’opportunité de rejoindre un environnement à taille humaine, dynamique et professionnel.
  • L’opportunité d’entrer dans une position évolutive d’un point de vue du contenu du travail.
  • Un contrat à durée indéterminée, avec possibilité de débuter par un 4/5ième
  • La possibilité de réaliser une entrée en fonction rapide.
  • Un package salarial attractif en phase avec votre 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.

Clinical Project Coordinator - Medical Device - Awans

Founded in 2009, CryoTherapeutics is an early stage European innovative company that is now establishing its operations in Awans (Liège). 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.

CryoTherapeutics recently raised 7M€ in its latest round of financing and will use these funds to continue the development of this technology with the aim of starting additional clinical studies later this year. For additional information about the company, please visit http://www.cryotherapeutics.com/

In order to support the expansion of the team in Awans, we are looking:

Clinical Project Coordinator

Responsibilities:

Reporting to and working closely with the Director of Regulatory and Clinical Affairs, as Clinical Project Coordinator, you are responsible for the operational management and the oversight of clinical trials according to the clinical strategy.

Your main responsibilities are :
  • Support clinical trials, including set-up of clinical documentation (protocol, investigator’s brochure, clinical QMS), site selection and qualification of investigators, EC/CA submission and regulatory reporting.
  • Facilitate and support staff for trial initiation, patient enrollment, compliance to the study protocol and use of the electronic database.
  • Ensure that physicians and staff are well trained and educated , and assist in clinical cases.
  • Ensure site monitoring, including scheduled visits, events reporting and documented interactions with clinical sites.
  • Compile required clinical documentation for regulatory submissions.
  • Work closely with the research team to ensure that all study procedures and visits occur as required in the protocol and timely entry of the data in the electronic database.
  • Represent the company in all regulatory and third party audits for clinical activities.
  • Deal with product-related site request and solve issues.
  • Engage with physicians and clinical staff, build relations and credibility.
  • Report results and work evolution on a regular basis to your line manager.
Profile:
  • Master’s degree in Biomedical Sciences, Bioengineering or any related field.
  • 3-7 years as Clinical Research Assistant or Clinical Project Leader at country or European level.
  • CRA/GCP training, preferably Medical Device GCP (ISO14155), and knowledgeable about regulatory requirements of medical device studies.
  • Experience in clinical trials for cardiovascular medical devices and/or ability to manage cases in cath lab is an asset.
  • Keen interest in scientific and technical issues related to clinical study.
  • Ability to work and collaborate effectively with internal and external actors.
  • Flexible, roll-up-sleeves attitude, self-directed and willing to travel when needed.
  • Excellent oral and written communication skills in English. Any other language is a plus.
  • Up to 30% 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.

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.

Quality Assurance Operational Lead - Pharmaceutical - Seneffe

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 Operational Lead

Responsabilités :

En tant que QA Operational Lead, vous rapportez directement au Quality Assurance Operational Manager et coordonnez la mise en œuvre de la politique d’assurance qualité relative aux activités de Novasep. Vous garantissez la conformité des référentiels selon les exigences et réglementations en vigueur.

Vos responsabilités principales sont :
  • Participer à un fonctionnement optimalisé du département AQ en conformité avec les principes des GMP et les requis Règlementaires, approuver les documents qualité et effectuer le QA « sur le terrain ».
  • Gérer le système documentaire afin de mettre à disposition des utilisateurs les informations leur permettant d’opérer toutes les activités de l’entreprise en ligne avec la politique qualité et conformément aux exigences des Bonnes Pratiques (GMP).
  • Vérifier et approuver le système de gestion des changements (Change Control) afin de garantir la traçabilité des modifications et de leurs rationnels.
  • Gérer le système de traitement des CAPA, Déviations / Non-Conformités afin de garantir que ces événements sont documentés, évalués, investigués et que des actions correctives efficaces sont mises en place.
  • Alimenter des indicateurs de performance et respecter les délais standards.
  • Vérifier et/ou approuver des SOP et autres documents qualité afin de développer le système qualité au sein de l’organisation.
  • Participer aux audits de l’entreprise.
Profil :
  • Vous êtes titulaire d’un diplôme à orientation scientifique ou équivalent par expérience.
  • Vous avez au moins 3 ans d’expérience dans un environnement biopharmaceutique, en qualité ou en production.
  • Vous avez de bonnes connaissances en matière de GMP et d’implémentation des systèmes qualité.
  • Vous maîtrisez la réglementation européenne et américaine de la production de produits pharmaceutiques à usage humain.
  • Vous maîtrisez parfaitement le français et parlez couramment l’anglais.
  • Vous avez un esprit entrepreneurial, êtes impliqué(e), autonome, organisé(e) et proactif(ve).
  • Vous avez une bonne capacité d’investigation, un esprit « problem solving » et de bonnes aptitudes analytiques et communicationnelles.
  • Vous êtes pragmatique, organisé(e), rigoureux (se) et avez un bon sens du compromis.
Offre :
  • Une fonction diversifiée comprenant de nombreuses responsabilités, avec la possibilité d’évoluer.
  • 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.

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.