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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.

Senior Software Developer - Medical Device - Liège

Founded in 2016, Oncoradiomics is an innovative and ambitious start-up established in Liège. Oncoradiomics’s strategic goal is to “revolutionize precision medicine”, by applying advanced artificial intelligence to clinical imaging.

Oncoradiomics focuses on tailoring cancer care to the clinical, imaging, biological and genetic characteristics of an individual patient so that the best outcome can be achieved.

Oncoradiomics holds several international grants and patents and is continuously developing and connecting with leading industrial and academic players to advance healthcare and the life sciences.

Senior Software Developer

Responsibilities:

Reporting to the CTO, your mission is to develop and manage the lifecycle of medical image software. Your main responsibilities are:

  • You expand existing software to meet the request for new functionality.
  • You port existing software to other environments, e.g. Python or C++.
  • You optimize the performance and the design of existing software.
  • You implement algorithms published in literature.
  • You focus on creating fault-tolerant programming.
  • You establish multi-platform versions of the software package (Docker).
  • You write and execute system tests for existing code to ensure validation and verification.
  • You write documentation for regulatory clearance.
  • You create scalable, automated and customer-oriented solutions.
Profile:
  • Bachelor’s or Master’s degree in Computer Sciences, IT, Electrical Engineering or related field.
  • At least 3 years of experience in a Software Engineer position within the industry.
  • Experience in medical image analysis/processing is a strong asset.
  • In-depth understanding of medical image standards, e.g. DICOM.
  • Proficiency in Python scripting.
  • Strong command of C++ and Matlab programming languages. Java is a plus.
  • Very good organizational, analytical and problem-solving skills.
  • Ability to work autonomously and in a team when required.
  • Good oral and written communication skills in English. Any other language is an asset.
Offer:
  • A challenging and diversified position within a high-potential innovative start-up company.
  • To work in a dynamic, respectful and professional
  • International exposure, with learning and development opportunities.
  • An attractive compensation 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.

Regulatory Manager - Medical Device - Liège

Founded in 2016, Oncoradiomics is an innovative and ambitious start-up established in Liège. Oncoradiomics’s strategic goal is to “revolutionize precision medicine”, by applying advanced artificial intelligence to clinical imaging.

Oncoradiomics focuses on tailoring cancer care to the clinical, imaging, biological and genetic characteristics of an individual patient so that the best outcome can be achieved.

Oncoradiomics holds several international grants and patents and is continuously developing and connecting with leading industrial and academic players to advance healthcare and the life sciences.

Regulatory Manager

Responsibilities:

As a Regulatory Manager, you lead and drive the execution of Oncoradiomics global regulatory strategy. Reporting to the CEO, you define and implement the regulatory policy in line with applicable directives, guidelines and legal requirements. Your main responsibilities are:

  • You drive regulatory strategy for EU/US markets: develop global regulatory strategies and drive the international product registration activities (with focus on EU, US, Canada, Australia, Japan, China and South Korea).
  • You prepare, organize, and submit global regulatory submissions/approvals.
  • You prepare and submit regulatory filings including, CE marking, traditional and special 510(k) applications, letters to file, technical files, etc.
  • You ensure regulatory requirements for establishment registrations, device listings, and registration licensing is maintained.
  • You perform MDR and MDV complaint reporting assessments.
  • You support the product development team in the implementation of regulatory requirements, including review of design input, risk management, and test documentation.
  • You perform regulatory assessment of product changes.
  • You proactively interpret regulatory guidelines and regulations, anticipate concerns, educate, and integrate requirements into product development programs.
  • You review and approve marketing materials to ensure compliance with advertising and promotional regulations.
  • You support internal and external audits.
Profile:
  • Master or PhD in life sciences or equivalent through experience.
  • 10 years experience in a RA position in the (software solutions) MedTech sector.
  • 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.
  • Fluency in English.
Offer:
  • A challenging and diversified position within a high-potential innovative start-up company.
  • To work in a dynamic, respectful and professional
  • International exposure, with learning and development opportunities.
  • 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.

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.

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.

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.

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.

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.