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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.

Responsable Administratif et Financier - Belgian Brewery - Péruwelz

La Brasserie Caulier est une entreprise familiale de la région de Tournai, située à Péruwelz. La brasserie produit ses propres bières depuis près de 20 ans et jouit d’une excellente réputation dans le secteur.

L’équipe actuelle, composée de 17 passionnés, brasse des bières 100% naturelles, appliquant des méthodes de fabrication artisanales. La brasserie connaît une croissance importante depuis quelques années et vient d’entamer un vaste plan d’investissement qui lui permettra de doubler sa capacité de production.

Afin de soutenir la croissance de la Brasserie Caulier, nous sommes à la recherche d’un (h/f) :

Responsable Administratif et Financier

Responsabilités :

En tant que Responsable Administratif et Financier, vous faites partie de l’équipe de direction et êtes responsable des composantes administratives, financières et RH de la brasserie. Par votre intervention, vous facilitez la gestion opérationnelle de l’entreprise et la prise de décisions stratégiques.

Vous principales responsabilités sont les suivantes :

  • Mettre au point les budgets annuels avec le directeur général et veiller à leurs suivis.
  • Définir et mettre en place un système de contrôle de gestion efficace, notamment en améliorant l’implémentation et l’utilisation de Microsoft NAVISION.
  • Prendre en charge l’ensemble des démarches administratives, comptables et juridiques liées à la gestion de la brasserie.
  • Implémenter une gestion efficace des RH pour anticiper les besoins de l’organisation (recrutement, formations, politique salariale, établissement fiche de paie, etc.).
Profil :
  • Vous êtes titulaire d’un Master en économie, finance ou gestion.
  • Vous avez entre 2 et 8 années d’expérience, dont une première expérience en contrôle de gestion. Une expérience dans l’implémentation d’un ERP est un avantage.
  • Vous démontrez une passion pour la gestion d’entreprise et le monde brassicole.
  • Vous disposez de très grandes compétences analytiques et organisationnelles.
  • Vous démontrez d’excellentes aptitudes communicationnelles et relationnelles.
  • Vous travaillez aisément en équipe, et vous êtes force de persuasion.
  • Vous êtes reconnu(e) pour votre rigueur, votre autonomie, votre sens de la diplomatie et votre capacité à travailler par projet.
  • Vous êtes pragmatique, et orienté(e) résultats et solutions.
Offre :
  • Une fonction diversifiée comprenant de nombreuses responsabilités.
  • Des possibilités de formations, de développement et d’évolution de carrière.
  • L’opportunité de rejoindre une entreprise familiale et conviviale, et de contribuer à sa forte croissance.
  • Un contrat à temps plein et à durée indéterminée, assorti d’un package salarial adapté à votre profil, à votre niveau d’expérience et au contexte.

Business developer – Smart-cities - Green Technologies - Germany

SmartNodes is a Belgian innovative green-tech start-up active in the smart cities’ sustainable development.

Based in Liège, SmartNodes develops smart street lighting solutions based on high-tech controllers to power street lighting only in presence of road users. The measurement of traffic density and user speeds is used for road mobility and safety applications. By integrating environmental sensors, parking sensors, etc., SmartNodes’ public lighting network is becoming the driving force behind Smart City networks. Please visit www.smartnodes.be.

SmartNodes’ customers are cities, regions and distribution network companies, worldwide. In order to develop its business, we are actively looking for an (m/f):

Business developer – Smart-cities

Responsibilities:

Reporting to the Business Development Manager, you expand SmartNodes’ business on an international scale, mainly in Germany and DACH region. In your assigned region, you develop the attractiveness of the brand on the market, and you reach the company’s sales targets.

Your main responsibilities are:

  • You analyse the market evolution, and identify business growth opportunities and risks.
  • You propose relevant sales actions plans in order to meet the sales objectives.
  • You initiate positive relations with prospects, customers and sales channels.
  • You lead all the sales process, including response to call for tender and deal closing.
  • You build, support and motivate an efficient sales network of local partners.
  • You develop adapted local marketing tools and actions.
  • You report work evolution on a regular basis.
Profile:
  • Master degree in Business, Engineering or equivalent through experience.
  • Ideally first level experience in a sales & marketing position with technical products. Junior profiles are also welcome.
  • Results and customer oriented, rigorous, autonomous and flexible.
  • Willing to deal with public sector oriented sales activities.
  • You are ready to travel around 50% of your work time.
  • Fluent in English and German. The command of French and any other language is an asset.
Offer:
  • A challenging business development position 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 including a stock options plan.

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.

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.

Junior Product Specialist - Medical Device - Liège

Headquartered in Liège, Dim3 develops and markets innovative eHealth software and devices in the area of Clinical nutrition to facilitate medical decisions and enhance the life of patients.

Dim3’s technologies bring a great knowledge of healthcare and clinical biometry together with disruptive 3D scanning and software engineering experience. Dim3’s clinical nutrition management tools and connected products integrate automatic medical data collection, interpretation and visualization to give healthcare professionals clear and objective information in real-time.

For more information, please visit: www.dim3.com

In order to support Dim3’s development, we are actively looking for a (m/f):

Junior Product Specialist

Responsibilities:

As a Junior Product Specialist, you guide Dim3’s products to even higher levels. You have a key role in the team. You deal with medical practitioners, customers and partners in order to determine the future direction of Dim3’s applications including specific features, functionality and business models. You deeply understand the pains patients feel and invent ways to translate their needs into smart software. In order to take on these responsibilities successfully, you’ll benefit from broad training and individual coaching.

Reporting to the CTO, you work in close cooperation with customers, the Management Team, Product Development, Clinical Affairs and Sales. Your main responsibilities are:

  • You initiate the product roadmap and strategy in line with market needs and business priorities.
  • You define the pricing strategy and constantly analyze market trends and competitors’ evolution.
  • You support the Sales team in analyzing customers project requirements, in defining adapted technical solutions, and in developing written and oral commercial proposals.
  • You define new products specifications or improvements in an efficient way.
  • You manage the release process in collaboration with the other departments.
  • You develop adapted local marketing tools and actions.
  • report work evolution on a regular basis.
Profile:
  • Master’s degree in Business, Engineering or equivalent through experience.
  • Ideally first level experience in Product Management. Experience in medical software and/or devices is a plus. Experience in nutrition is also an asset. New graduates are also welcome.
  • Results and customer oriented, rigorous, autonomous and flexible.
  • Analytical, organized, team player, open-minded with a start-up mind-set.
  • Fluent in English. The command of French or any other language is an asset.
  • Strong oral and written communication.
  • Willing to travel for short periods (20% of your time) on a regular basis.
Offer:
  • A challenging position with direct impact on patients’ health and quality of life.
  • The opportunity to jump into an innovative medical software engineering company, a fast-growing start-up environment where teamwork, results and patient care are very important.
  • Varied contacts with professionals on an international scale.
  • Coaching and training path adapted to your needs.
  • An attractive salary package and evolution opportunities.

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 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.

Research Assistant – Flow Cytometry and Serology – Evenings and weekends – - 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.

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 – Flow Cytometry and Serology – Evenings and weekends

Function :

Reporting to the Associate Director, Operations 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. You will receive a strong training to further develop your skills in cellular and humoral immunology.

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;
Profile of the applicant :

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.  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.
  • Must be able to work evenings and weekend hours.
  • 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 of 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.
  • Strong training and development opportunities.
  • A competitive salary package including benefits (and premium for evenings and weekend hours), adapted to your experience and the context.

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.