Jobs

Define your goal, step up your career.

Quality, Security & Environment

4 results

Head of RA - 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 RA

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.

Quality Assurance Manager - Medical Device - Flemalle

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 is launching its industrialization and production activities in a brand new production unit.

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. For more information please visit: www.wishbone-biotech.com

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

Quality Assurance Manager

Responsibilities:

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

Your main responsibilities are:

  • Manage the Quality Management System according to the EU ISO 13485, the US FDA 21 CFR Part 820 and any other relevant regulatory requirement in accordance with the Quality Policy.
  • Ensure that required processes of the Quality Management System (QMS) are documented, established, implemented and maintained.
  • Assure that products have been supplied, manufactured, analyzed and released according to specifications and approved SOP’s and to appropriate standards and regulations.
  • Organize and document the Management Review according to the company QMS. Recommend and drive improvements.
  • Perform supplier audits, internal and external audits and interact with suppliers and customers to deal with non-conformities and drive continuous improvement.
  • Support 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.
  • Manage materiovigilance activities including incident and post-market surveillance reporting.
  • Ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
  • Report to the top 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 English. Any other language is a plus.
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 professional
  • To work in a human size, dynamic, respectful and professional environment.
  • An attractive compensation package in line with the position responsibilities and your experience.

Responsable QHSE - Energie - Dunkerque

Dunkerque LNG (Dunkerque Liquefied Gaz Naturel) est une filiale à 65 % du groupe EDF SA, 25 % de l’opérateur belge Fluxys et 10 % de Total. L’exploitant du terminal méthanier de Dunkerque est Gaz-OPALE, filiale d’exploitation de Dunkerque LNG.

GAZ-OPALE est en charge de la conduite, de la maintenance et du respect des exigences HSE (Hygiène Sécurité et Environnement). Le terminal méthanier est un site ICPE (Installation Classée pour la Protection de l’Environnement) qui suit la directive SEVESO III seuil haut.

Responsable QHSE

Responsabilités :

En tant que Responsable QHSE, votre mission est de définir et coordonner la politique «qualité, hygiène, sécurité et environnement» de l’ensemble du terminal méthanier. Pour ce faire, vous pouvez compter sur une équipe de 2 personnes et sur un réseau de partenaires externes. Rapportant au Directeur d’Exploitation, vous faites partie du Comité de Direction de Dunkerque LNG.

Vos principales responsabilités sont les suivantes :

  • Implémenter et coordonner le système de gestion de la sécurité : élaboration des plans d’urgence et mise en œuvre d’exercices.
  • Coordonner la sécurité du site, gérer et analyser les événements et incidents.
  • Évaluer et sensibiliser aux risques des postes de travail.
  • Participer au Comité d’Hygiène, de Sécurité et des Conditions de Travail (CHSCT).
  • Obtenir la triple certification Iso 9001, 14001, OHSAS 18001 par la mise en œuvre de documents contrôlés.
  • Garantir la mise en œuvre des évolutions réglementaires et assurer la gestion des déchets.
  • Veiller à la bonne application des règles d’accès au site.
  • Participer aux astreintes de la cellule de crise opérationnelle à raison d’une semaine sur cinq.
Profil :
  • Vous êtes titulaire d’un Bac+5 QHSE, scientifique, ou équivalent par expérience.
  • Vous possédez une expérience réussie de 5 à 10 ans en tant que Responsable QHSE d’un site industriel type SEVESO. Une première expérience en management est un plus.
  • Vous communiquez aisément en français et en anglais.
  • Vous êtes autonome, rigoureux(se) et faites preuve d’un esprit d’ouverture, d’écoute et de synthèse.
  • Vous appréciez le travail d’équipe et possédez une grande aisance relationnelle.
  • Vous êtes habitué(e) à travailler dans un environnement structuré et exigeant (ISO 9001-14001, OHSAS 18001).
  • Vous êtes basé(e) dans les environs de Dunkerque et êtes disposé(e) à vous déplacer ponctuellement en France et à l’étranger (Bruxelles, Zeebrugge, etc.)
Offre :
  • Une fonction stimulante au sein d’un environnement diversifié.
  • L’opportunité de rejoindre un acteur majeur dans l’industrie du gaz en Europe.
  • Des challenges et des contacts variés au sein et en dehors de l’organisation.
  • Des opportunités de développement et de formations.
  • Un salaire attractif reprenant des avantages extra-légaux avantageux.

Quality Systems Manager - Bio-Pharma/Biotech - South of Brussels

Our client is a fast-growing company that provides immunology-related analytical services to pharmaceutical and biotech companies internationally.

The company is located 50km South of Brussels. To strengthen the team, we are currently looking for a (m/f):

Quality Systems Manager

Responsibilities:

Reporting to the Quality Assurance Director, you are responsible for maintaining and enhancing the Quality Systems. You will oversee and manage Quality Assurance activities, ensuring GLP, GCP, GCLP, ISO/IEC 15189 Quality Processes, Training and Qualification.

Your main responsibilities are:

  • Develop, implement, maintain and enhance Quality Systems and associated procedures.
  • Participate in obtaining appropriate certification or accreditation.
  • Update and maintain Quality Assurance logs, databases, and generate metrics.
  • Provide GxP compliance, general QA support and guidance to personnel.
  • Conducts internal and external audits.
  • Develop, write and review SOPs to ensure compliance with applicable regulatory and corporate standards.
  • Participate in the development and delivery of internal training programs.
  • Review and evaluate investigations, findings and resolutions, change control, CAPAs, non-conformances, and audit observations.
  • Review CAPAs to determine effectiveness, perform trend analysis and compile summary reports.
  • Report compliance risks to senior management.
  • Support equipment and software validations.
Profile:
  • You hold a bachelor’s degree in Life Science, or equivalent through experience.
  • You have 5+ years of quality and/or compliance related experience in CRO industry, working in a regulated environment with direct QA responsibility.
  • You have excellent knowledge, understanding, and application of ISO/IEC 15189, GCP, EMA, OECD in relation to Good Laboratory Practice (GLP) and/or GCLP quality requirements;
  • You have good knowledge in Drug Development, Validation of Analytical Methods, Quality Assurance and Regulatory Compliance, applied to various bioanalysis techniques.
  • You demonstrate documentation management skills, ability to design and implement quality processes;
  • You have a high level of attention to detail and accuracy, and excellent investigative techniques;
  • You have strong leadership, management and communication skills;
  • You are able to identify and/or resolve quality issues, discrepancies with others in a proactive, diplomatic, flexible and constructive manner;
  • You are able to independently convey information with authority, handle highly sensitive matters and interact with high-level contacts within other organizations.
Offer:
  • A full-time permanent position within a fast-growing company.
  • A dynamic, professional and stimulating work environment.
  • Training and development opportunities.
  • An attractive compensation package in line with the position responsibilities and your experience.

Other career opportunities

42 results

Ingénieur Commercial - Energie - Paris

Dunkerque LNG est en charge de l’exploitation et de la commercialisation du terminal méthanier de Dunkerque, deuxième plus grand terminal méthanier d’Europe continentale.

Fort d’un chiffre d’affaire annuel de 190€ millions, Dunkerque LNG est un atout majeur dans le développement de la stratégie d’approvisionnement en gaz du groupe EDF en raison de son raccordement unique à deux marchés de consommation : la France et la Belgique.

La société est composée d’une vingtaine de collaborateurs répartis sur les sites de Dunkerque et de Paris La Défense.

Afin de renforcer l’équipe commerciale de Dunkerque LNG à Paris, nous sommes activement à la recherche d’un (h/f) :

Ingénieur Commercial

Responsabilités :

En tant qu’Ingénieur Commercial, vous participez activement au développement du terminal tant d’un point de vue commercial qu’opérationnel. Rapportant au Directeur Commercial, vous êtes responsable de la relation commerciale avec les clients et les différents partenaires de Dunkerque LNG.

Vos principales responsabilités sont les suivantes :

  • Entretenir et développer la relation commerciale avec les clients de Dunkerque LNG, EDF et Total.
  • Veiller au respect des contrats de réservation de capacité et de leur mise en œuvre opérationnelle.
  • Supporter la Direction Commerciale dans le pilotage de la relation contractuelle et/ou opérationnelle des prestataires : suivi du contrat de service, lancement et réception de nouveaux développements, etc.
  • Prospecter de nouveaux clients, notamment en participant à différents forums et salons industriels.
  • Planifier et gérer l’activité du terminal : bateaux, émission, stock, etc.
  • Rapporter de manière régulière la performance commerciale et opérationnelle du terminal.
  • Participer aux astreintes de soutien à raison d’une semaine sur quatre.
Profil :
  • Vous êtes titulaire d’un Bac+5 de type école de commerce, d’ingénieur ou universitaire.
  • Vous êtes fraichement diplômé(e) ou possédez une première expérience dans le secteur gazier.
  • Vous êtes orienté(e) clientèle, résultats et solutions, et doté(e) d’un très bon relationnel.
  • Vous êtes flexible, autonome, organisé(e), analytique et rigoureux(se).
  • Vous communiquez aisément en Français et en Anglais.
  • Vous êtes basé(e) à Paris La Défense et disposé(e) à vous déplacer de manière régulière à Dunkerque et ponctuellement à travers le monde.
Offre :
  • Une fonction stimulante au sein d’un environnement diversifié.
  • L’opportunité de rejoindre un acteur majeur dans l’industrie du gaz en Europe.
  • Des challenges et des contacts variés au sein et en dehors de l’organisation.
  • Des opportunités de développement et de formations.
  • Un salaire attractif reprenant des avantages extra-légaux avantageux.

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.

Responsable Comptable - Energie - Paris

Dunkerque LNG est en charge de l’exploitation et de la commercialisation du terminal méthanier de Dunkerque, deuxième plus grand terminal méthanier d’Europe continentale.

Fort d’un chiffre d’affaire annuel de 190€ millions, Dunkerque LNG est un atout majeur dans le développement de la stratégie d’approvisionnement en gaz en raison de son raccordement unique à deux marchés de consommation : la France et la Belgique.

La société est composée d’une vingtaine de collaborateurs répartis sur les sites de Dunkerque et de Paris La Défense.

Afin de renforcer l’équipe finance de Dunkerque LNG à Paris, nous sommes activement à la recherche d’un (h/f) :

Responsable Comptable

Responsabilités :

Rapportant au Directeur Financier, vous assurez le pilotage et la gestion de la comptabilité de Dunkerque LNG et sa filiale, Gaz-Opale. En binôme avec le Contrôleur de Gestion, vous êtes garant de la bonne tenue des états financiers mensuels et annuels des deux sociétés.

Vos principales responsabilités sont les suivantes :

  • Piloter les comptes sociaux de Dunkerque LNG et Gaz-Opale, dans le respect des procédures comptables.
  • Coordonner et assurer le suivi de la comptabilité des fournisseurs et des clients.
  • Être l’interlocuteur principal des Commissaires aux comptes (interne et externe).
  • Veiller au suivi des flux de trésorerie et des actifs immobilisés.
  • Encadrer de manière opérationnelle les personnes en charge du suivi des contrats.
  • Participer au Comité Financier à raison d’une fois par trimestre.
  • Rapporter de manière régulière et structurée l’évolution des démarches réalisées.
Profil :
  • Vous êtes issu d’une formation supérieure type bac + 5 (École de commerce, Master, etc.) spécialisée en comptabilité, gestion/Finance.
  • Vous disposez de 5 ans d’expérience sur un poste similaire.
  • Vous appréciez manipuler les chiffres et bénéficiez de solides connaissances en comptabilité générale.
  • Vous maitrisez les outils Microsoft Office et les logiciels comptables (idéalement SAP).
  • Vous êtes rigoureux(se), organisé(e), analytique et appréciez le travail en équipe.
  • Vous communiquez aisément en Français et vous avez de bonnes connaissances en Anglais.
  • Vous êtes basé(e) à Paris La Défense et disposé(e) à vous déplacer de manière ponctuelle à Dunkerque.
Offre :
  • Une fonction stimulante au sein d’un environnement diversifié.
  • L’opportunité de rejoindre un acteur majeur dans l’industrie du gaz en Europe.
  • Des challenges et des contacts variés au sein et en dehors de l’organisation.
  • Des opportunités de développement et de formations.
  • Un salaire attractif reprenant des avantages extra-légaux avantageux.

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.

Medical Director - 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 is backed by strong international investors.

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 Director

Responsibilities:

As a Medical Director, 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:
  • MD, ideally in neurology or in neurosciences.
  • At least 5 years of relevant working experience in the pharmaceutical Industry, in hospitals or in biotech 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, and 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

Research Assistant – Flow Cytometry and Serology - Bio-Pharma/Biotech - Gosselies

Caprion Biosciences is a contract research organisation with facilities in Montreal (Canada) and Gosselies (Belgium). Caprion Biosciences offers analytical services to biopharmaceutical companies ranging from mass spectrometry-based analytical services to the characterization of the human immune response in clinical samples.

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

In the context of its growing immune monitoring service offering in Gosselies (Belgium), we are looking for a (m/f):

Research Assistant – Flow Cytometry and Serology

Responsibilities :

Reporting to the Laboratory Manager and working closely with Principal Scientists, the Research Assistant will work within a team focusing on the characterization of the cellular (ELISPOT and various flow cytometry assays such as phenotyping of PBMC, detection of intra-cellular cytokines, etc) and of the humoral (ELISA, Luminex, viral neutralization tests, etc) immune response.

Tasks include :

  • Perform immunoassays according to current standard operating procedures;
  • Participate to the writing and/or to the review of method SOP and worksheets;
  • Manage reagents inventories and orders;
  • 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;
  • Depending on the experience level of the candidate, additional tasks may include:
    • Act as a leader in the laboratory for specific studies;
    • Work with the Principal Scientist to prepare experimental plans needed for the conduct of immune monitoring assays;
    • Participate in the development and qualification/validation of complex methods;
    • Participate in experiment planning and problem solving.
Profile :

The applicant must hold a bachelor degree or a master’s degree (or the equivalent) in a life science discipline such as biology, medical biology or biochemistry/biotechnology and demonstrate a relevant laboratory experience. Theoretical and practical knowledge of techniques related to cellular and humoral immunology is required. Experience in cell culture and handling infectious materials in BL2+ environment is an asset.

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 and interesting projects.
  • A professional, dynamic and stimulating work environment.
  • Training and development opportunities.
  • A competitive salary package including benefits, adapted to your experience and the context.

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 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.

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.

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.