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Bio-Pharma/Biotech

6 resultaten

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.

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.

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.

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.

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.

Product Design and Process Development Manager - 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):

Product Design and Process Development Manager

Responsibilities :

As Product Design & Process Development Manager, you are responsible for all CMC-related technical operations activities, including overall management of process and product development, production of non GMP batches. You ensure the work is performed in compliance with Quality 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 the non-GMP productions.
  • Manage all drug substance and drug product activities of technology transfer to GMP unit.
  • Identify, select and oversight subcontractor for process optimization, non-GMP manufacture of Drug Substance (API) and Drug Product (DP).
  • Deliver robust, scalable, industrialisable and cost-effective manufacturing routes.
  • 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.
  • Supports, informs and aligns with cross functional project management team members such as preclinical development, QC, QA, RA units.
Profile :
  • Master degree or PhD in science, bioengineering or related.
  • At least 5 years relevant experience in a pharmaceutical or biotech environment.
  • Relevant expertise in lab techniques focused on protein purification and analysis..
  • Thorough knowledge of relevant FDA and EMEA regulations is an asset.
  • 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.

Andere loopbaanmogelijkheden

37 resultaten

International Technical Project Manager - Industry - Genk

Created in 2011, Aperam is a leading global stainless steel and specialty steel producer with key industrial facilities located in France, Belgium, Germany and Brazil. Aperam is successfully implementing a strategy based on operational efficiency and innovation in their products and services.

Aperam products are sold in over 40 countries to customers in the aerospace, automotive, medical, construction, household appliances, catering and industrial processes industries. In 2017, Aperam employed about 9,600 people with a turnover of $5.051 million.

In order to join its center of industrial excellence in Genk, we are looking for an (m/f):

International Technical Project Manager

As an International Technical Project Manager, you implement and follow up global projects in the different plants (mainly in Europe) in the field of robotization, automation, digitalization/connectivity, production IT (MES, WMS, ERP Interfaces), energy saving, process innovation and shop floor layout.

Responsibilities:
  • Manage end-to-end projects: initiation, planning, implementation, monitoring, close-out, etc.
  • Participate in the company’s digital transformation (Industry 4.0).
  • Accelerate the achievement of business objectives and set up new innovative projects.
  • Be responsible for the conception, calculation and quoting of automation solutions for the Aperam production network.
  • Define and develop Aperam automation standards.
  • Set up and report the project KPIs on quality control, timing, budget and stakeholder satisfaction.
  • Collaborate in the project team as a competent partner for automation.
  • Communicate with different internal and external stakeholders : suppliers, institutes, experts, etc.
  • Report work evolution on a regular basis.
Profile:
  • Master degree in engineering with a specialization in mechatronics, electricity, electromechanics or energy management.
  • Minimum 5 years of experience as a Technical Expert in an industrial environment with a few years’ experience in continuous improvement project management.
  • A certification in project management (preferably Prince 2).
  • Strong leadership and communication skills with hands-on and pragmatic mindset.
  • Autonomy, proactivity, analytical and problem solving skills.
  • Ability to work within a multicultural environment.
  • Willingness to travel around 60% of your work time.
  • Fluency in English. Knowledge of other European languages is a plus.
Offer:
  • A unique career opportunity to participate in internal and external training courses, following a guided learning path on both technologies and processes.
  • A real career booster and transition to higher and transverse positions within the group.
  • An international exposure, with learning and development opportunities.
  • The opportunity to travel to the different company sites in Europe and Brazil.
  • 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 Design Assurance 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):

Principal Design Assurance Engineer

Responsibilities:
  • You provide design assurance support and oversight for product development activities throughout product lifecycle.
  • You create, review and/or execute IQ, OQ, PQ and test method development.
  • You ensure product development follows company procedures and design control requirements.
  • You review and approve design verification and design validation test protocols and reports.
  • You support protocol sample size calculations and data analysis with use of acceptable use of statistical methods/techniques.
  • You drive robust design reviews within R&D teams.
  • You ensure compilation and maintenance of product Design History Files.
  • You document traceability of requirements through design output and to design verification and/or design validation.
  • You lead the risk management process for pre-market and post-market assessments of assigned products.
Profile:
  • Bachelor or Master’s degree in Engineering, Life Sciences or another related field.
  • 10+ years’ experience working in a Quality or Engineering capacity with Class III medical devices. Experience with catheters and active devices preferable.
  • Experience with all phases of the product development process including clinical investigation.
  • Experience in creating and maintaining Risk Management Files.
  • 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 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.

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.

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.

Commercieel Vertegenwoordiger – Lupulus - Belgian Brewery - Vlaanderen

Brouwerij Lupulus, opgericht in 2007, is een Belgisch familiebedrijf in volle expansie. Ze brouwt de Lupulus-bieren, kwaliteitsproducten die bekend staan voor hun voortreffelijke smaak.

Lupulus is internationaal op de markt gebracht en neemt stilaan een vooraanstaande plaats in tussen de meest bekende speciale bieren. Haar uitstekende reputatie heeft ze te danken aan de knowhow en de passie van haar brouwers.

Brouwerij “Lupulus” is gelegen in de provincie Luxemburg en bestaat uit ongeveer twintig dynamische en sympathieke medewerkers. Om onze aanwezigheid in België te ontwikkelen, zijn wij op zoek naar (m/v):

Commercieel Vertegenwoordiger – Lupulus

Verantwoordelijkheden:

In Antwerp, Limburg en Nederland zijn dit uw voornaamste verantwoordelijkheden:

  • Vertrouwensrelaties opbouwen met het volledige handelsnetwerk: cafés, restaurants, hotels, winkels, distributeurs,…
  • De verkoop en de zichtbaarheid van het merk Lupulus bevorderen.
  • Regelmatige contacten met en professionele opvolging van de klanten verzekeren.
  • Marketingtools ontwikkelen in functie van de commerciële doelstellingen.
  • Optimale relaties met de klanten opbouwen en onderhouden op lange termijn.
  • De concurrentie volgen en op de hoogte zijn van de evoluties in de sector.
  • Regelmatig en gestructureerd verslag uitbrengen over de evolutie van de ondernomen stappen.
Profiel:
  • U hebt al een eerste ervaring in de verkoop, de voorverkoop of de verkoopsondersteuning.
  • U bent vertrouwd met commerciële relaties en onderhandelingen.
  • U bent georganiseerd, autonoom, volhardend, resultaat- en klantgericht.
  • U hebt interesse in bieren en de verkoop.
  • U drukt zich vlot uit in het Nederlands (mondeling en schriftelijk) en in het Frans.
  • U bent bereid zich regelmatig te verplaatsen in het u toegewezen werkgebied.
  • U leef ideaal in Antwerp of in Limburg.
Aanbod:
  • Een commerciële functie in een gezellig bedrijf in volle expansie.
  • De mogelijkheid om Belgische kwaliteitsproducten te commercialiseren.
  • Gevarieerde contacten in heel het toegewezen werkgebied.
  • Mogelijkheden tot opleiding, ontwikkeling en evolutie op middellange en lange termijn.
  • Een aantrekkelijk salaris met extralegale voordelen, dat overeenstemt met uw ervaring.

Développeur Firmware embarqué - Engineering - Perwez

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 à Perwez, 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 en Brabant Wallon, à Perwez.
  • Des opportunités de formation et de développement.
  • Une offre salariale attrayante, assortie d’avantages extralégaux compétitifs comprenant entre autres une voiture de société.