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Technical Advisor - Automobile - Brussels

Based in Brussels (Belgium), FIGIEFA is the European federation and political representative of the independent wholesalers and retailers of automotive replacement parts. Together with its 19 national European Member State members, it represents the interests of more than 30.000 companies trading with vehicle parts, components and accessories throughout Europe.

The aim of FIGIEFA is to safeguard a legislative environment in the EU that provides access to technical information, to the ‘connected vehicle’ and its in-vehicle data as well as to replacement parts/equipment as the basis for free and fair competition in the automotive aftermarket in a rapidly changing automotive technology environment.

In order to support the activities of its office in Brussels, we are currently looking for a (m/f):

Technical Advisor

Responsibilities:

As a Technical Advisor, you manage all technical and ‘connected vehicle’ IT-related dossiers and processes in connection with FIGIEFA’s activities in the area of the automotive aftermarket.

Your main responsibilities are:

  • Advise FIGIEFA in all technical and ‘connected vehicle’ IT-related matters.
  • Participate in meetings (in Brussels or EU) and take responsibility for the management of technical subjects and dossiers (e.g. telematics, EC type-approval legislation).
  • Support the FIGIEFA Secretariat in its information activities and meetings.
  • Advise and prepare answers on upcoming questions from the EU institutions and help in the preparation of position papers.
  • Liaise with FIGIEFA’s partner alliance AFCAR (Alliance for the Freedom of Car Repair in the EU).
  • Communicate with FIGIEFA legal/political experts and work out common strategies, statements, papers and positions.
  • Report results and work evolution on a regular basis.
Profile:
  • You are an experienced automotive technical expert or are experienced in vehicle-related IT technologies around the ‘connected vehicle’ (e.g. telematics and cybersecurity).
  • You are, preferably, specialised in vehicle communication, vehicle design/functionality, diagnostics or contemporary and developing vehicle technologies.
  • You have excellent oral and written communication skills in English and strong interpersonal skills.
  • You are flexible, proactive, and able to work on your own as well as in close cooperation with the FIGIEFA Secretariat.
  • You are able to assess the business consequences of new legislation, automotive technologies and vehicle related services.
  • You are ready to travel frequently to other European countries.
Offer:
  • A challenging position within a multi-national and political environment that tackles a wide range of technical issues.
  • The opportunity to support and promote free and fair competition in the automotive aftermarket and to safeguard a legislative environment at EU level.
  • Various contacts with European and international institutions while representing the interests of FIGIEFA members.
  • An attractive salary package in line with the position responsibilities and your experience.

Technico-Commercial - Medical Device - Forest

Située à Forest et composée d’une vingtaine de personnes, Dumont Instruments est une entreprise familiale qui existe depuis près de 40 ans. La société est active dans la conception, la production et la commercialisation de fraises de haute précision pour outils rotatifs.

Sa clientèle se compte principalement dans le secteur dentaire en France et en Belgique (dentistes, laboratoires de prothèses dentaires, etc.), mais également parmi certaines industries en Europe et dans le monde. Pour plus d’informations, veuillez visiter www.dumont-instruments.com.

Pour accompagner le Directeur Industrie dans le développement commercial de la société, nous recherchons activement un (m/f) :

Technico-Commercial

Responsabilités :

En tant que Technico-Commercial, vous participez au développement commercial de la société. Rapportant au Directeur Industrie, vous l’accompagnez dans ses différentes missions.

Vos principales tâches sont les suivantes :

  • Veiller au suivi administratif et logistique des différents contrats (ex : facturation des clients, réception des commandes, etc.).
  • Assurer la coordination de la production du pôle industrie.
  • Proposer des solutions techniques et commerciales adaptées aux besoins des clients.
  • Développer une relation de confiance avec les clients et les fournisseurs afin d’assurer une bonne collaboration sur le long terme.
  • Prospecter de nouveaux clients et augmenter la visibilité de Dumont Instruments.
  • Rapporter de manière régulière et structurée l’évolution des démarches réalisées.
Profil :
  • Vous êtes titulaire d’un Bachelier en mécanique ou électromécanique.
  • Vous êtes fraichement diplômé(e) ou possédez une première expérience dans une fonction technique ou technico-commerciale.
  • Vous êtes orienté(e) clientèle, résultats et solutions, et doté(e) d’un bon relationnel.
  • Vous êtes passionné(e) par la technique liée à l’usinage de précision, curieux(se) et avez l’envie d’apprendre.
  • Vous êtes analytique, organisé(e), autonome et rigoureux(se).
  • Vous communiquez aisément en français et en anglais (oral et écrit). La connaissance du Néerlandais est un atout.
  • Vous êtes disposé(e) à vous déplacer environ 25% de votre temps sur le territoire confié (prioritairement en Belgique, France et Luxembourg).
Offre :
  • Une fonction commerciale stimulante dans une entreprise conviviale et dynamique.
  • L’opportunité de commercialiser des produits belges dont la qualité est internationalement reconnue.
  • Des contacts diversifiés sur l’ensemble du territoire confié.
  • Un parcours de formation dès votre entrée en fonction et tout au long de votre carrière au sein de Dumont Instruments.
  • Un contrat à durée indéterminée à temps plein.
  • Un salaire attractif assorti d’avantages extra-légaux, en phase avec votre expérience.

Research Associate – Target expression - Biotechnology - Brussels

Confo Therapeutics, a spin-off of VIB and VUB, is a drug discovery company built around a disruptive technology which enables it to address ‘undruggable’ GPCRs. The company is building a portfolio of transformative medicines in various disease areas.

Confo Therapeutics is currently located on the Etterbeek campus of the Vrije Universiteit Brussel and on the Technology Park in Zwijnaarde/Ghent. More information about Confo’s technology and strategy can be found on www.confotherapeutics.com.

For the expansion of the target discovery team in Brussels, we are looking for a (m/f):

Research Associate – Target expression

Responsibilities:
  • You will help to implement a state of the art cell culture lab and build an efficient cell culturing engine for different eukaryotic hosts.
  • You will overexpress GPCRs in different eukaryotic expression hosts and assess recombinant receptor expression (transient and stable cell lines).
  • You support the Confobody discovery teams to assess conformation sensitivity of antibodies in cell based assays.
  • You manage Confo Therapeutics’ cell line culture capacity and inventory aligned with the Data Management System.
  • You communicate experimental progress to the project teams.
Profile:
  • Bachelor in life sciences with at least one year experience in eukaryotic cell culturing in an industrial setting.
  • Proficient in eukaryotic cell transfection techniques and methods to assess heterologous protein expression such as flow cytometry and radioligand assays.
  • Experienced operator of flow cytometer and capable to analyse flow cytometry data is an asset.
  • Scientific integrity, solid analytical and problem solving skills.
  • Working accurately and self-motivating.
  • Enthusiastic team player in a small company setting.
  • Excellent communication skills in English.
Offer:
  • A competitive compensation package with extensive benefits.
  • An entrepreneurial and stimulating working environment in a growing and ambitious biotech company.
  • Excellent career development opportunity, with exposure to all aspects of R&D in the company.

Pharmacien d’Industrie (QP) - Bio-Pharma/Biotech - Woluwé-Saint-Lambert

Située à Woluwe-Saint-Lambert, ß+ Pharma est une société spécialisée dans la production de radio-isotopes innovants à usage médical et destinés au diagnostic de maladies oncologiques, cardiologiques et neurologiques. Sa production couvre les besoins de ses clients sur le territoire du BeNeLux et une partie de la France.

Fondée en 2002 et composée de 11 collaborateurs, ß+ Pharma offre un environnement dynamique et un réel esprit d’équipe permettant l’épanouissement de tous ses employés.

ß+ Pharma est une spin-out de la société IBA, dont elle utilise la technologie pour la production des radio-isotopes. Actuellement, la société fait partie du groupe Curium Pharma, actionnaire à 75%.

Afin de contribuer au développement de ß+ Pharma, nous sommes activement à la recherche d’un (h/f):

Pharmacien d’Industrie (QP)

Responsabilités:

En tant que Pharmacien d’Industrie (QP), vous supervisez la production des radio-pharmaceutiques dans le respect des normes GMP et vous assurez la libération des lots. Vous rapportez directement au Radio Pharmacien Responsable.

Vos principales tâches sont :

  • Libérer les lots produits en veillant à respecter les délais et les normes de qualité.
  • Participer aux activités de fabrication des radio-pharmaceutiques.
  • Assurer le bon fonctionnement des activités de maintenance, de qualification, de validation et

    d’approvisionnement du service.

  • Effectuer, en collaboration avec le Responsable QC, le suivi de contrôle des matières premières.
  • Gérer le système de qualité en accord avec les normes GMP.
  • Participer aux audits fournisseurs ainsi qu’aux audits sur les autres sites de production européens.
  • Participer à la formation initiale et continue du personnel.
  • Rapporter de manière régulière votre travail.
Profil:
  • Vous disposez d’un Master en Pharmacie, d’un Master complémentaire en Pharmacie Industrielle ainsi que d’un numéro QP.
  • Vous êtes fraichement diplômé(e) ou démontrez une première expérience dans le domaine en industrie (radio-/bio-)pharmaceutique.
  • Vous êtes respectueux(se), digne de confiance et aimez le travail en équipe.
  • Vous êtes flexible et faites preuve de rigueur.
  • Vous êtes dynamique et proactif(ve) et disposez de bonnes capacités de communication.
  • Vous maitrisez l’anglais et le français à l’oral comme à l’écrit.
Offre:
  • Une fonction diversifiée au sein d’une société en développement.
  • L’opportunité de rejoindre un environnement à taille humaine, dynamique et professionnel.
  • Un parcours de formation dès l’entrée en fonction et tout au long de votre évolution.
  • Un contrat à durée indéterminé assorti d’un package salarial attractif.

Stagiaire en Recrutement - Consultance RH - Bruxelles/Gosselies/Mont-Saint-Guibert

PaHRtners est une entreprise belge de consultance en Ressources Humaines (RH). Nos bureaux sont situés à Woluwe-Saint-Lambert (Bruxelles), à Gosselies et à Mont-Saint-Guibert (Wallonie).

Nous sommes notamment spécialisés dans le recrutement et la sélection de scientifiques, d’ingénieurs, d’experts et de top managers. Nous fournissons ces services principalement aux secteurs industriels et de la santé.

Les valeurs-clés sur lesquelles repose notre approche sont l’authenticité, la transparence et le respect. Consultez www.pahrtners.be ou contactez info@pahrtners.be pour plus d’info.

Pour renforcer l’équipe, nous recherchons actuellement un(e) :

Stagiaire en Recrutement

– pour 4 à 6 mois –

Tâches :

En tant que stagiaire, vous recevrez tout d’abord une solide formation. Sous la supervision du responsable de stage, vos principales tâches seront les suivantes :

  • Exploiter les outils modernes de recrutements : réseaux sociaux, bases de données, approche directe, cooptation, etc.
  • Rédiger et publier des annonces sur les sites Internet.
  • Participer au sourcing, screening et à la pré-sélection des profils identifiés.
  • Contacter les profils identifiés et assurer un suivi professionnel tout au long de la procédure.
  • Réaliser des prises de références professionnelles.
  • Participer aux entretiens de sélection, et débriefing.
  • Assister aux Assessment/Development Centers et analyser les compétences.
  • Assurer une bonne gestion administrative des dossiers de recrutement.
  • Réaliser des projets visant l’amélioration du service.
Profil :
  • Bachelor ou Master en RH, Psychologie, Business, Sciences ou Ingénieur.
  • Une réelle motivation à découvrir le monde du recrutement et de la chasse de têtes.
  • Un intérêt pour le monde industriel et scientifique.
  • Rigoureux(se), autonome et proactif(ve). Convivialité et curiosité intellectuelle.
  • Bonne communication en Français. L’anglais et le néerlandais sont des atouts.
  • Disposé(e) à vous rendre à Woluwe-Saint-Lambert ou à Gosselies par vous-même.
  • Aisance avec l’informatique et le web.
Offre :
  • Un stage de 4 à 6 mois en recrutement au sein d’une structure professionnelle.
  • Une solide formation reconnue dans le monde du recrutement.
  • Une réelle opportunité d’apprentissage et de réalisations concrètes.
  • Une opportunité de travailler sur des recrutements locaux et internationaux.
  • Un accompagnement individualisé et une autonomie grandissante.
  • Des horaires flexibles et modulables, une ambiance de travail ouverte et décontractée.
  • Un démarrage de stage selon vos préférences.

Autres opportunités de carrière

39 résultats

Head of CMC - Bio-Pharma/Biotech - Liège

ASIT Biotech is a Belgian clinical-stage biotech company focused on the development of breakthrough immunotherapy products for the treatment of allergies.

Thanks to its innovative technology platform, ASIT Biotech currently holds a leading and unique position on the market. This innovation results in a short treatment, expected to improve patient compliance and quality of life. ASIT Biotech’s product pipeline targets to significantly expand the current immunotherapy market. For more information about the company, please visit www.asitbiotech.com.

With a headcount of 25 staff members, ASIT Biotech is located in Liège, Belgium. In order to support its high-potential developments, we are looking for a (m/f):

Head of CMC

Responsibilities :

As Head of CMC, you are responsible for all CMC-related technical operations activities, including overall management of process and product development, selection and oversight of the pharmaceutical supply chain, technology transfer, manufacturing and supply of clinical trial material. You ensure the Quality and RA compliance of CMC-related activities with the corporate policies.

You report directly to the CEO and are part of the Executive management.

Your main responsibilities include:

  • Lead the overall management of product and process development.
  • Manage all drug substance and drug product activities from technology transfer to clinical supplies for clinical studies.
  • Identify, select and manage CMOs for process optimization, cGMP manufacture, supply, testing, release and distribution of Drug Substance (API) and Drug Product (DP).
  • Manage the non-GMP productions and associated analytical development activities.
  • Deliver robust, scalable and cost-effective manufacturing routes.
  • Implement appropriate analytical methods and protocols in coordination with QA.
  • Ensure the compliance of all CMO with relevant regulatory standards.
  • Define and execute plans for API and DP validation and registration, in coordination with QA and RA.
Profile :
  • PhD in Life Science with at least 10 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment.
  • Relevant expertise in lab techniques focused on protein expression, isolation and analysis.
  • Strong experience in managing CMOs for the manufacture of cGMP APIs and DP.
  • Experienced in cGMP manufacturing and IND, CTA and NDA regulatory filings.
  • Thorough knowledge of relevant FDA and EMEA regulations.
  • Experience with implementing technical, strategic and operational plans.
  • Excellent communication and organizational skills.
  • Ability to identify and resolve critical issues.
  • Fluency in French and English.
Offer :
  • A challenging leading position within a stimulating and dynamic work environment.
  • A variety of interesting contacts with international exposure.
  • The opportunity to have direct impact on the results of a high-potential biotech company.
  • An attractive compensation package in line with the position responsibilities and your experience.

Medical Officer - Biotech, Biotechnology - Mont-Saint-Guibert

NOVADIP BIOSCIENCES (www.NOVADIP.com) is an innovative biotech company expert in the development of novel regenerative medicines. This human-sized structure is a leader in new generation therapies for hard & soft tissue reconstruction from autologous adipose stem cells.

NOVADIP BIOSCIENCES shows the ambition to grow to a worldwide class, with a successful closing of a 28M€ fund raising. Its main objective for the coming years is to develop its portfolio of products and to perform clinical validation and process industrialization of its main compounds.

NOVADIP BIOSCIENCES is a French/English-speaking work environment based in Mont-Saint-Guibert (close to University of Louvain-la-Neuve and Brussels area), Belgium, Europe.

In order to support our clinical development, we are actively looking for a (m/f):

Medical Officer

Responsibilities:

As a Medical Officer, you are part of the Medical Department consisting of the Chief Medical Officer, a Compliance Manager, 2 Clinical Project Managers, 2 Clinical Research Associates and a Clinical Research Assistant. You closely collaborate with them.

Your main responsibilities are as follows:

  • Design, contribute and write new study protocols and documentation related to clinical trials (IMPD/IND, investigator brochure, sponsor master files, patient informed consent, CRF, monitoring plan, safety plan /DSMB…) and contribute to the design of clinical development plans.
  • Develop and maintain a network of medical experts in the field and work in close collaboration with internal departments (i.e. R&D, Regulatory Affairs, Manufacturing, logistics…).
  • Identify, screen, select, initiate clinical sites, CROs, and other sub-contractors in the future trials in collaboration with clinical team.
  • Set up pharmacovigilance program (standalone or in collaboration with CRO).
  • Manage the interactions with ethics committees.
  • Monitor trials from a medical point of view, together with internal staff and clinical sites personnel.
  • Review incoming clinical data, and write medical reports or any other scientific files in collaboration with the Chief Medical Officer.
  • Facilitate communication flow between the clinical sites, CROs and Novadip.
  • Share your knowledge with the teams in order to overcome scientific, operational, regulatory, marketing, financial and strategic challenges within the company.
  • Active participation in training/coaching of operational teams involved in clinical trials (internal and external).
  • Report to the Chief Medical Officer.
Profile:
  • MD, PhD in Medical Sciences or Master in sciences or related field.
  • Min. 5 years of experience within either a CRO or a Pharma/Biotech/Medtech company. Experience in cell therapy is a great asset.
  • In depth understanding of clinical development plans, clinical trials, and superior knowledge of IHC-GCP.
  • Interest in basic sciences and translation of medical science in new clinical trials protocols.
  • Good communication skills with both clinical and non-clinical contacts.
  • Excellent attention to details and established organizational skills.
  • Demonstration of flexibility, professionalism, good interpersonal skills and managerial skills.
  • Fluency in written and spoken English is required. Good level of Dutch or French is desired.
  • Willingness and ability to be based in Belgium and to travel nationally and internationally.
  • To be in the possession of a full driving license.
Offer:

A diversified full-time permanent position within a high-potential innovative biotech company.

  • To work in a human-sized, dynamic, respectful and professional environment.
  • The opportunity to take part in a challenging scientific and business growth.
  • Varied contacts inside the company and with the biotech/pharma sector.
  • An attractive salary package in line with the position responsibilities and your experience.

Principal Scientist - Bio-Pharma/Biotech - Gosselies

Caprion Biosciences, a contract research organisation with facilities in Montreal (Canada) and Gosselies (Belgium), offers analytical services to biopharmaceutical companies for the characterization of the human immune response in pre-clinical and clinical samples.

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

For its site in Gosselies and in the context of its growing immune monitoring service offering, Caprion is looking for a (m/f) :

Principal Scientist

Responsibilities :

Reporting to the Director of 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 (phenotypic, ICS, etc) ELISPOT, ELISA, Luminex 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
  • Acting as a key resource to provide guidance and support in root cause analysis and impact assessment
  • Overall conduct of studies in different immune-therapeutic areas, acting as primary contact to the client for communication of study progress
  • Data interpretation, report generation and presentation of results to clients
Profile :

The applicant must hold a doctorate degree in life science, with strong knowledge of immunology, with post-doctoral experience (or equivalent) and have a deep expertise of flow cytometry analysis. The applicant must also have a minimum of two years of experience in the industry.

The applicant must :

  • Be proficient with analysis software such as FlowJo, Pestle, Spice, Prism and Excel and be able to perform complex analysis of flow cytometry data such as Boolean analysis.
  • 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 studies.
  • Be willing to work in a Quality environment (ISO17025, GCLP, GMP) and apply good documentation practices (GDP).
  • Be fluent in English (written & spoken) and able to functionally communicate in French.
Offer :
  • Full time permanent contract.
  • Diversified tasks and responsibilities and interesting projects.
  • A professional, dynamic and stimulating work environment.
  • Development opportunities.
  • A competitive salary package including benefits, adapted to your experience and the context.

Medical Advisor - Biotechnology - Gosselies

Our client is a clinical stage biotech company leading the development of new therapies for rare diseases affecting the central nervous system. The company’s leading program is currently in an ongoing phase II/III clinical trial in EU and US, with results expected in 2020. In the upcoming months, our client is planning to launch a clinical trial for a second orphan indication.

For more information about the company, please contact us via recruitment@pahrtners.be

Founded in Spain, the company is opening a subsidiary in Gosselies (Belgium). In order to strengthen the team in Belgium, we are currently looking for a (m/f):

Medical Advisor

Responsibilities:

As a Medical Advisor, you provide scientific support to the company as a whole and particularly to planned ongoing clinical research activities. You collaborate with an internal multidisciplinary team to successfully execute the company’s development program strategies and operations.

Your main responsibilities are:

  • Provide medical expertise for project and study development.
  • Write clinical trial materials, including trial synopsis and protocol.
  • Monitor ongoing clinical studies for protocol adherence and safety.
  • Contribute to and review documentation related to clinical trials (e.g. investigators brochures).
  • Review clinical study reports designed by third parties.
  • Screen information from journal publications and conference presentations for relevant developments in the company’s indications.
  • Develop and maintain broad and deep relationships with external partners.
 Profile:
  • Degree in Life Science, biological science, or other related area. A medical Degree in neurology or pediatric medicine is an asset.
  • At least 5 years of relevant working experience in the Pharmaceutical Industry or in Biotech/Startup companies.
  • Extensive knowledge of all aspects of GCP and regulations.
  • Experience in clinical research in orphan indications or with brain imaging technologies is an asset.
  • Strong collaboration, documentation and presentation skills.
  • Flexibility, good time management, team-working skills, stress resistant, ability to work proactively and independently.
  • Well-developed communication skills, problem solving skills, creative and critical thinking.
  • Fluent in English. A good command of French and/or Catalan is an asset.
  • Prepared to travel to the Spanish site regularly, clinical investigational sites, conferences and meeting with regulators.
Offer:
  • An interesting position within a high-potential clinical stage biotech company.
  • The opportunity to work in a human-sized and multicultural team environment.
  • A variety of interesting contacts with international exposure.
  • An attractive salary package in line with the position responsibilities and your experience.

Product Regulatory Affairs Specialist - Medical Device - Wavre

Founded in 2011, iSTAR Medical is a clinical-stage medical technology company that aims to provide leading patient care through the design, manufacturing and marketing of novel ophthalmic therapies.

iSTAR Medical develops innovative ophthalmic implants for patients with glaucoma. The ophthalmic implants are made from proprietary STAR® material, a technology from the University of Washington in Seattle (USA). For additional information about the company and the technology, please visit http://www.istarmed.com/

In order to support the development of the company, we are currently looking for a (m/f) :

Product Regulatory Affairs Specialist

Responsibilities:

As Product Regulatory Affairs Specialist, you are in charge of writing the technical documentation to support clinical study applications, CE marking and FDA registration. You insure compliance of product technical files with regulatory standards and provide support to ensure that regulatory standards are part of the Product Development Process.

Your main responsibilities are:

  • Write technical documentation including Investigator Brochures, Clinical Protocols, Product Risk Analysis, Biocompatibility Risk Assessments.
  • Prepare technical files for Clinical Studies filings, CE-Mark applications and FDA registrations.
  • Maintain technical documentation to ensure compliance with internal QMS and Regulatory Standards.
  • Support R&D and Manufacturing to define the product/process validation strategies in compliance with Regulatory Standards.
  • Ensure that normative and regulatory changes are identified in a proactive manner and coordinate actions plans.
  • Manage product registration processes.
  • Report work evolution on a regular basis.
Profile:
  • Master’s degree or Ph.D. degree in Science or equivalent through experience.
  • At least 5 years of experience supporting Regulatory Affairs for Medical Devices Class IIb.
  • Strong technical writing skills (Investigator Brochures, Clinical Study Protocols, Risk Management).
  • Good knowledge of Microsoft Office applications.
  • Excellent interpersonal, communication and presentation skills.
  • High level of attention to detail, excellent organizational skills and time management, flexibility.
  • Fluent in English, written and spoken. Knowledge of another language is an asset.
  • Willing to travel abroad occasionally.
Offer:
  • A full-time permanent position within a high-potential medical device company with direct impact on the lives of patients.
  • A professional, dynamic and stimulating work environment.
  • A variety of interesting contacts with international exposure.
  • An attractive compensation package in line with the position responsibilities and your experience.

Clinical Trial Manager - Biotechnology - Gosselies

Our client is a clinical stage biotech company leading the development of new therapies for rare diseases affecting the central nervous system. The company’s leading program is currently in an ongoing phase II/III clinical trial in EU and US, with results expected in 2020. In the upcoming months, our client is planning to launch a clinical trial for a second orphan indication.

For more information about the company, please contact us via recruitment@pahrtners.be

Founded in Spain, the company is opening a subsidiary in Gosselies (Belgium). In order to strengthen the team in Belgium, we are currently looking for a (m/f):

Clinical Trial Manager

Responsibilities:

Reporting directly to the Director of Clinical Operations and working closely with the team in Spain, you are responsible for the operational management and the oversight of clinical trials according to the clinical strategy.

Your main responsibilities are:

  • Coordinate clinical trial in collaboration with selected CRO.
  • Visit clinical study sites regularly and interact with study members.
  • Ensure successful execution of the clinical trials on time and on budget.
  • Review study related documentation and materials.
  • Co-monitor clinical study for protocol adherence and safety with selected CRO.
  • Ensure that clinical trial activities are documented in accordance with regulatory requirement.
  • Create and maintain effective relationships with KOL.
  • Report results and work evolution on a regular basis to the Director of Clinical Operations.
Profile:
  • Master’s or bachelor’s degree in Life Science or equivalent through experience.
  • At least 5 years of relevant experience in clinical trials.
  • Extensive knowledge of all aspects of GCP and regulations.
  • Track record on managing clinical studies on time & on budget.
  • Good collaboration, documentation and presentation skills.
  • Flexibility, good time management, team-working skills, stress resistant, ability to work proactively and independently.
  • Well-developed communication skills, problem solving skills, creative and critical thinking.
  • Excellent command of Microsoft Office Tools (Excel, Word, PowerPoint).
  • Fluent in English. A good command of French or Catalan is an asset.
  • Prepared to travel to Spanish site regularly, clinical investigational sites, conferences and meeting with regulators.
Offer:
  • An interesting position within a high-potential clinical stage biotech company.
  • The opportunity to work in a human-sized and multicultural team environment.
  • A variety of interesting contacts with international exposure.
  • An attractive salary package in line with the position responsibilities and your experience.

Interested ?

Head of Regulatory Affairs - Bio-Pharma/Biotech - Liège

ASIT Biotech is a Belgian clinical-stage biotech company focused on the development of breakthrough immunotherapy products for the treatment of allergies.

Thanks to its innovative technology platform, ASIT Biotech currently holds a leading and unique position on the market. This innovation results in a short treatment, expected to improve patient compliance and quality of life. ASIT Biotech’s product pipeline targets to significantly expand the current immunotherapy market. For more information about the company, please vist www.asitbiotech.com.

With a headcount of 25 staff members, ASIT Biotech is located in Liège, Belgium. In order to support its high-potential developments, we are looking for a (m/f):

Head of Regulatory Affairs

Responsibilities:

As a Head of RA, you lead and drive the execution of ASIT global regulatory and quality assurance strategy. Reporting to the CEO, you are responsible for regulatory affairs, quality assurance, and compliance activities across the company. You define and implement the quality and regulatory policies in line with applicable directives, guidelines and legal requirements.

Your main responsibilities are as follows:

  • Develop, propose and implement the company regulatory & quality strategy.
  • Manage regulatory documents submissions for clinical studies, and product approvals.
  • Implement an efficient quality system and a continuous improvement culture within the company.
  • Interact with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, and follow-up of
submissions.
  • Support and advise project teams on regulatory and quality issues.
  • Provide technical review of data and reports for regulatory submissions.
  • Draft product labelling, instruction leaflets and packaging.
  • Participate in internal/external audits, inspections and provide post-inspection
follow-up.
  • Write and update SOP, work instructions, and policies.
Profile:
  • Master or PhD in life sciences or equivalent through experience.
  • 10 years experience in a RA and/or a QA management position in the Biotech/Pharma sector.
  • Track record in developing quality systems from EU/US clinical developments to product approval.
  • Thorough knowledge of ICH guidelines, GxP and related regulatory guidances.
  • Proven track record of building strong relationships with internal and external stakeholders.
  • Ability to maintain multiple projects and meet timelines, including change management skills.
  • Client-centered and solution-oriented, with hands-on and pragmatic mindset.
  • Excellent leadership, communication and interpersonal skills.
  • Familiar with MS Office solutions.
  • Fluency in English.
Offer:
  • A challenging leading position within a stimulating and dynamic work environment.
  • A variety of interesting contacts with international exposure.
  • The opportunity to have direct impact on the results of a high-potential biotech company.
  • An attractive compensation package in line with the position responsibilities and your experience.

Développeur Firmware embarqué - Engineering - Luxembourg

Créée en 2008, ShifTech Engineering est une entreprise spécialisée dans le domaine de la préparation de moteur sur banc de puissance. Composée d’une équipe de 15 personnes, ShifTech Engineering est actuellement présente en Belgique, en France, au Luxembourg et en Chine, et jouit d’une renommée internationale pour la qualité de ses réalisations et services destinés aux particuliers. Pour plus d’informations sur l’entreprise, veuillez consulter www.shiftech.eu.

Shiftech Engineering développe depuis 3 ans un nouveau produit hardware. Celui-ci permet au préparateur du monde entier de lire puis d’écrire les données d’un calculateur moteur. Pour plus d’informations sur le produit, veuillez consulter www.autotuner-tool.com

Dans le cadre du renforcement de l’équipe de Shiftech Engineering au Luxembourg, nous sommes activement à la recherche d’un (m/f) :

Développeur Firmware embarqué

Responsabilités :

En collaboration avec le chef de projet et notre Ingénieur Firmware, vous participez aux activités de développement de l’outil Autotuner. Vos principales responsabilités sont :

  • Analyser, développer et améliorer le code C déjà existant suivant les développements de nouveaux calculateurs moteur.
  • Etre en charge du développement des scripts LUA suivant le protocole CAN de la voiture.
  • Rapporter et présenter de manière structurée, rigoureuse et adaptée les résultats des activités.
  • Effectuer du reverse engineering.
Profil :
  • Vous disposez d’un Master en IT ou électronique.
  • Vous jouissez, idéalement, de 3 à 5 années d’expérience dans une fonction de développement Firmware en milieu industriel ou équivalent.
  • Vous possédez une excellente maîtrise de Python et du langage C. La connaissance des scripts LUA et de FreeRTOS est un atout majeur.
  • Vous êtes à l’aise avec Git ou tout autre logiciel de gestion de sources.
  • Vous faites montre d’un bel intérêt pour l’esprit start-up qui encourage la créativité et l’innovation.
  • Vous aimez les challenges et vous montrez de réelles affinités pour les innovations technologiques.
  • Vous communiquez aisément en français et en anglais.
  • Vous êtes analytique, proactif(ve), autonome, organisé(e) et rigoureux(se).
Offre :
  • Une fonction technique diversifiée et stimulante dans une petite équipe jeune et dynamique.
  • Intégrer une structure en pleine expansion et de renommée dans le domaine automobile pour la qualité de ses services.
  • Un cadre de travail agréable et d’accès aisé, et la possibilité de homeworking.
  • Un contrat à durée indéterminée à temps plein au Luxembourg, à Redange-sur-Attert.
  • Des opportunités de formation et de développement.
  • Une offre salariale attrayante, assortie d’avantages extralégaux compétitifs comprenant entre autres une voiture de société.

Business developer – Smart-cities - Green Technologies - Germany

SmartNodes ist ein innovatives belgisches Green-Tech Startup, das in der nachhaltigen Entwicklung der Smart Cities aktiv ist.

Mit Sitz in Lüttich entwickelt SmartNodes intelligente Straßenbeleuchtungslösungen, die auf High-Tech-Controllern basieren, um Straßenbeleuchtung nur in Anwesenheit von Verkehrsteilnehmern zu be-treiben. Durch die Integration von Umweltsensoren, Parksensoren usw. wird das öffentliche Lichtnetz von SmartNodes zur treibenden Kraft hinter Smart City-Netzwerken. Bitte besuchen Sie unsere Homep-age unter www.smartnodes.be.

Kunden von SmartNodes sind Städte, Regionen und Vertriebsnetzwerke weltweit. Um unsere geschäft-lichen Aktivitäten weiterzuentwickeln, suchen wir aktiv nach einem (m/w):

Business developer – Smart-cities

Verantwortlichkeiten:

Sie leisten dem Business Development Manager Berichterstattung und erweitern somit mit dessen Unterstützung das Geschäft von SmartNodes auf internationaler Ebene, hauptsächlich in Deutschland und der DACH-Region. In Ihrer Region entwickeln Sie die Attraktivität der Marke auf dem Markt und erreichen die Verkaufsziele des Unternehmens.

Ihre Hauptaufgaben sind:

  • Sie analysieren die Marktentwicklung und identifizieren Geschäftswachstumschancen und -risiken.
  • Sie schlagen relevante Verkaufsaktionspläne vor, um die Verkaufsziele zu erreichen.
  • Sie initiieren positive Beziehungen zu Interessenten, Kunden und Vertriebskanälen.
  • Sie führen den gesamten Verkaufsprozess, einschließlich der Antwort auf Ausschreibungen und Geschäftsabschluss.
  • Sie konstruieren, unterstützen und motivieren ein effizientes Vertriebsnetz lokaler Partner.
  • Sie entwickeln angepasste lokale Marketing-Tools und Aktionen.
  • Sie berichten regelmäßig über die Entwicklung der Arbeit.
Profil:
  • Master-Abschluss in Business, Engineering oder gleichwertig durch Erfahrung.
  • Idealerweise eine erste Erfahrung in einer kaufmännischen Position mit technischen Produkten. Juniorprofile sind ebenfalls willkommen.
  • Ergebnis- und kundenorientiert, streng, autonom und flexibel.
  • Bereit, sich mit den Aktivitäten des öffentlichen Sektors zu befassen.
  • Sie sind bereit, ungefähr 50% Ihrer Arbeitszeit zu
  • Sie sprechen fließend Englisch und Deutsch. Weitere Sprachkenntnisse, insbesondere der französischen Sprache, sind von Vorteil.
Angebot:
  • Eine herausfordernde Geschäftsentwicklungsposition in einem schnell wachsenden Start-up- Unternehmen.
  • Die Möglichkeit, in ein Unternehmen für nachhaltige Entwicklung und grüne Technologien einzu
  • Vielfältige Kontakte zu Fachleuten auf internationaler Ebene.
  • Bedeutende Lern- und Entwicklungsmöglichkeiten.
  • Ein attraktives Gehaltspaket inklusive eines Aktienoptionsplans.

Senior product engineer - Medical Device - Awans

Miracor Medical is a class IIb/III medical device company specialized in improving clinical outcome of patients with impaired cardiac function, active in interventional cardiology. The company has developed a high potential proprietary technology that consists of hardware, software and catheter(s).

The technology is in advanced clinical stages, with various potential therapeutic applications (among others acute infarct and heart failure). More than 190 patients have been treated with the recent version of the technology. The company aims at getting CE Mark and approval from FDA to run a pivotal study in the next 2 years.

Miracor Medical’s offices are based in Awans, Belgium. The company 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):

Senior product engineer

Responsibilities:
  • You initiate and manage related projects.
  • You guide/manage risk management activities.
  • You create/review technical documentation and processes (as part of DHF, DMR, QMS).
  • You create verification and validation plans and coordinate their execution; apply statistical techniques in order to define samples sizes.
  • You organize and execute subjective evaluations (product reviews) to ensure all (product) requirements are met.
  • You review manufacturing documentation such as procedures/processes, BOMS and drawings.
  • You transfer and oversight of parts of manufacturing processes.
Profile:
  • Master’s degree in Engineering, Informational Systems or Computer Science.
  • 10+ years’ experience working in development of Class III (minimum IIb) medical devices (or other relevant regulated industry).
  • Ideally experience with hardware/software and catheters.
  • Experience in creating Risk Management plan, (Software) Hazard Analysis, DFMEA, PFMEA, Risk Management reporting.
  • Deep understanding of MDD (MDR), FDA 21 CFR 820, ISO13485 and ISO14971 standards
  • In-depth knowledge of the concepts of: design control, engineering change control, statistical techniques, verification and validation methods/protocols, design history files (DHF) and device history and master records (DHR/DMR).
  • Extensive understanding of statistical analysis, measurement and calibration systems, quality testing, sampling and inspection, process control, SOPs, etc.; Six Sigma certificate.
  • Excellent organisational and communication (oral and written) skills.
  • Ability to work on teams as well as individually.
  • Fluent in English (oral and written).
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.