Clinical Research Laboratory Senior Analytical Technician
Will you be our new ambassador?
Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to join our team.
Let's look together at your first challenge with us!
Scope of work:
Laboratory
Ensure the control of the laboratory environment, safety specification, the maintenance and calibration of laboratory material required to conduct clinical trials.
Responsible for orders of the laboratory (identification of supplier, making contact, order tracking, …)
Must be able to follow written and oral instructions and comply with safety and laboratory procedures.
Creation/review and update SOP’s of the laboratory when it is necessary
Sample Management
Ensure quality throughout sample processes and beyond
Manage all necessary preparations in regard to the laboratory for adequate execution of a protocol in a timely manner
Ensure proper lab samples handling (documents for staff use: trolley sheet, centrifugation sheet, urine collection sheet, order Lab supplies, etc…)
Support setting up of EDCMS as appropriate
Ensure proper inventory management in Eworkbook
Analytical
Perform all routine and special clinical chemistry, hematological, coagulation, and urinalysis, immunological and other tests according to the Standard Operating Procedures.
Implement and validate new assays. May assist with assay development. Coordinates with the guidance of the Managers new methods validation and instruments implementation.
Perform all quality control checks (monitor trends) on instruments, reagents, and techniques, maintain quality control and calibration data.
Prepare and check reagents and supplies. Perform calculations for work solutions or other calculations as required during experimental procedures.
Perform and document required routine maintenance and calibration of laboratory instruments.
Maintain the inventory of and order laboratory supplies including notifying instrument key operators of upcoming reagent/supply needs.
Process samples for analysis or storage. Utilize PIMS/LIMS computer system for the processing of samples.
Assist the Laboratory Quality Coordinator with preparation for Internal audits and BELAC audits.
Identify new lab equipment if necessary
Support new lab technique (biomarkers, material, etc…)
Assisting in the validation of methods when it is necessary
Others:
Provide ongoing and accurate information and support Volunteers/Patients regarding clinical trials to facilitate subject compliance
Monitor and document study subject compliance
Maintain accuracy, accessibility, and confidentiality in volunteer/patient records
Record and communicate or resolve any discrepancy to study protocols in regards to laboratory
Facilitate positive attitude and trust by the volunteer/patient population toward participation in clinical research
Ensure development of new procedures required by the protocol as “superuser” and train staff accordingly
Perform safety inspection of laboratories and surrounding office area as assigned and prepare a report
May Participate in protocol reviews and provid specialized oversight and technical assistance in regards to the laboratory and liaise with the PI and the Clinical Project Manager
May be assigned to be mentor/sponsor for a new colleague
Training
Participate in training courses as appropriate
Organize and assist in the training of PCRU staff and contractors with less experience and expertise
May Ensure Lab training requirements are fully achieved for protocol execution and for all protocol related procedures
Responsible for complying with Pfizer Standards, ethical standards, ICH, regulatory and legal requirements, national and European laws on health and safety at work, fire prevention and other appropriate legislation
Perform all quality control checks (monitor trends) on instruments, reagents, and techniques, maintain quality control and calibration data.
Prepare and check reagents and supplies. Perform calculations for work solutions or other calculations as required during experimental procedures.
Perform and document required routine maintenance and calibration of laboratory instruments.
Maintain the inventory of and order laboratory supplies including notifying instrument key operators of upcoming reagent/supply needs.
Process samples for analysis or storage. Utilize PIMS/LIMS computer system for the processing of samples.
Assist the Laboratory Quality Coordinator with preparation for Internal audits and BELAC audits.
Identify new lab equipment if necessary
Support new lab technique (biomarkers, material, etc…)
Assisting in the validation of methods when it is necessary
Perform safety inspection of laboratories and surrounding office area as assigned and prepare a report
May Participate in protocol reviews and provid specialized oversight and technical assistance in regards to the laboratory and liaise with the PI and the Clinical Project Manager
Experience:
Minimum of a Diploma/Bachelor degree Medical Biology or equivalent
Superior written and verbal skills are essential; including the ability to communicate complicated research principles in easily understandable language.
Must be available for various shifts (weekends/evenings/nights/public holiday)
English language skills is highly recommended, your second language would be French or Dutch
Excellent communication skills Minimum of 3 years of Laboratory experience
Clinical skills
Successful study conduct of all Clinical Research Unit studies in accordance with ethical, legal, and moral standards, Good Clinical Practices (GCPs) and Good Clinical Laboratory Practices (GCLPs), WRD management requests and drug development goals.
Computer skills
Working knowledge of computers and ability to adapt rapidly and easily to clinical research data systems and associated issues/risks
Teamwork:
ability to function in diverse workgroups to accomplish business objectives
What can Jefferson Wells do for you?
As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.
Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to join our team.
Let's look together at your first challenge with us!
Scope of work:
Preparation and Online submission of Clinical Trial Applications in CTIS
Responsible for communication with the NCP, for preparing the required Part 1 and Part 2 files and completing CTA submissions in the CTIS platform
Responsible within the Regulatory Team to ensure that studies are conducted scientifically and ethically and in compliance with EMA/FDA/ICH/GCP guidances and regulations/laws
Lead the administrative work related to completion of trials (CSR, ASR, SUSAR, AE, etc.), and ensure proper documentation and communications to relevant stakeholders.
Part 1: Competent Authorities files
Coordinates with PCRU PIs and Pharmacists, RegCMC and Dev Ops colleagues to ensure timely availability and accuracy of all the required IMP-related documents.
Coordinate and ensure the translations and redaction of relevant submission files for assigned protocols.
Part 2: Ethics Committees files
Solicit input from local clinical teams on assigned synopses, protocols and Informed Consent Documents (ICDs) where appropriate
Ensure the accuracy of managed ICDs and their translations, as well as related regulatory documents for assigned protocols (recruitment strategy, all other participant-facing documents, …).
Other Activities
Responsible for study-specific tasks such as site registration in CTMS/Oracle Siebel and Shared Investigator Platform (SIP), QC and filling of study documents in PTMF as well as maintenance and archiving of study files (ISF)
Act as an SME for SOP updates and review within the functional line
Responsible for providing oversight on specialized regulatory related PCRU projects
Liaison to the project teams for studies scheduled in the PCRU to provide inputs on regulatory aspects (EU CTR, Belgian law, …)
Responsible for the implementation of new processes and work to proactively resolve issues where appropriate
Develop knowledge of the GDPR and optimize its implementation at the PCRU
Lead PCRU teams in accomplishing business needs and resolving issues;
Represent the PCRU on local or global initiatives as a subject matter expert where appropriate
Develop and maintain relationships with schools and universities for training site registration
Give input in PCRU documentation to facilitate positive attitude and trust of participants toward clinical research.
Participates to the successful study conduct of PCRU studies in accordance with ethical, legal, and moral standards, Good Clinical Practices, Good Laboratory Practices, PCRU management requests, Clinical Development and operations (CD&O) and Global product Development (GPD) goals.
Profile:
General experience requested specific to the project:
Bachelor degree in Management, Life Sciences or equivalent, with relevant experience in Regulatory Affairs.
Autonomous but with a strong team spirit
Accountable, with very keen sense of initiative and leadership skills
Strong organizational skills, multiple projects flexibility and very good resistance to stress or a high workload, with focus on the agreed timelines.
Detail oriented, precise in oral and written communication
Strong IT skills: advanced use of MS Office tools such as Outlook, Word, Excel, PowerPoint, Teams, OneNote.
Min. 5 years of experience in pharma, of which at least some years in a regulatory environment
Working knowledge of ICH and GCP guidelines required
Strong understanding and knowledge of regulatory aspects of drug development
Languages: Fluent in French, Dutch and English (written and spoken)
Technical experience requested specific to the project
Scientific / Medical Knowledge
Understanding of basic clinical pharmacology principles, with ability to review emerging safety and efficacy profile of a drug candidate and recognize potential serious adverse effects.
Demonstrated understanding of the complexities and recent developments in exploratory research.
What can Jefferson Wells do for you?
As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.
Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to join our team.
Let's look together at your first challenge with us!
Scope of work:
The Belgium manufacturing site is one of the global leaders in the production of biological drug products and mRNA-based vaccines. The current projects being selected would operate within a major investment program to accelerate the adoption and deployment of such Industry 4.0 tools and advanced analytics for all side of the business: Manufacturing, Quality Control, Quality Assurance, Supply Planning, Sustainability, etc. You would be a tactical project leader that works to scope and define a business case for a certain initiative, defines User Requirements Specifications (URS), performs solution development (AI modeling, method development, program robotics, etc), pilots the solution and then validate its intended use.
Profile:
You have 2-4 years within the Pharma Industry (newly graduated candidates can be considered)
You hold a Master in Chemical/Process engineering, Biotech engineering, Mechanical engineering with Robotics majors
You have knowledge of digital programs with AI/ML majors
You have relevant fields of science: Chemistry/Biomedical Sciences
English is mandatory (must) as there will be contact at international level.
Dutch knowledge (even intermediate level) is a plus as there will be contact with the floor – production site.
French could be used with the sponsor (bilingual FR/ENG)
What can Jefferson Wells do for you?
As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.
Pour notre client spécialisé dans les solutions de condenseurs à air, nous sommes à la recherche d'un Technical Buyer avec des connaissances en tuyauterie et acier. Une expérience en industrie lourde est un plus.
Les projets sont de l'ordre de plusieurs millions d'euros (entre 1 et 12).
Vous allez jouer un rôle central dans les projets car 75% des pièces qui composent le produit final sont achetées.
Qui êtes-vous ?
Vous devez avoir une bonne maîtrise du marché, du produit et des fournisseurs. Vous devez aussi avoir des connaissances en tuyauterie, acier. L'expérience en industrie lourde est un plus. Idéalement, vous avez un background en mécanique mais la formation peut être également de type: ingénieur, droit ou économie.
Vous êtes structuré, intègre, curieux, avez l’envie de comprendre et d’apprendre. Il est primordial que vous puissiez savoir faire un Total Cost of Ownership. L'anglais pour la fonction est obligatoire (niveau C1).
Que pouvez-vous espérer ?
Nous vous offrons un contrat à durée indéterminée ainsi qu'un package salarial attractif. Vous profiterez également de l'opportunité de vous développer personnellement et professionnellement à travers des formations internes.
Before sizing an industry, a company needs to propose the best project and price to be selected. It’s the role of the Proposal Engineer to get the perfect match between best technologies and best prices.
Integrated within the sales and marketing team, your mission will be to assure major proposals and manage both technical and commercial offers, facing directly or indirectly with customers. You will work in a human size company on international project.
What are your responsibilities?
Strategic link between the different departments, you define the offer strategy, analyse the technical and commercial specifications issued by the client and manage the implementation of the proposal
Designing and developing creative tailor-made solutions, you lead the co-operation with the Engineering, Innovation and Project Management department, always in compliance with the company standards and processes
You implement sourcing strategy with the Supply Chain department and build up budget by gathering quotes from subvendors.
You assemble all technical and commercial inputs into a final proposal, following up with the client to ensure our proposal is in line with expectations, till the closing of the bid phase
You visit regularly your main customers all over the world to defend our offers
You build and develop a network within our customers and suppliers for present and future business opportunities
You continuously and proactively seek out opportunities (new suppliers / new applicable solutions) to improve proposal costs
Who are you?
Master’s Degree in Engineering
You combine a very strong technical background with a commercial ability or the willingness to develop it
You have knowledge of thermal engineering and experience in industrial cooling systems (dry or wet)
Strong leadership and born team-player, you are able to build bridges with and between other departments.
Flexible, polyvalent and able to multi-task, you are at ease in a dynamic and fast evolving environment and open to global cultural diversity.
Strong excel abilities required. VBA programming knowledge is a plus.
You are fully proficient in English, knowledge of German is an asset
Willing to travel up to 20%
What can you expect?
You will work in a small, dynamic and agile international enterprise with highly talented colleagues. You will receive a comfortable compensation package with good fringe benefits and the opportunity to grow and develop in your skills, competencies and career.
Jefferson Wells Life Sciences is gespecialiseerd in de ondersteuning van farma & biotech bedrijven in hun dagelijkse uitdagingen. Vandaar onze interesse in experts zoals jij om ons team te versterken.
Laten we samen kijken naar jouw eerste challenge bij ons!
Labo- technicus medewerker brand/chemie
functie:
Als labo-technisch medewerker sta je op een cruciale plaats aan het begin van een diverse en boeiende ketting doorheen onze labo’s.
Je voornaamste taak is het voorbereiden en het beheren van het staalmateriaal bestemd voor het testen in de diverse labo's.
Voorbereiding van staalmateriaal: knippen, stansen, boren, zagen, reinigen, kleven, stikken en andere voorbereidende werkzaamheden om het ontvangen staalmateriaal klaar te maken voor verder onderzoek en testen;
Voorraad van verbruiksgoederen en staalrestanten beheren;
(Op termijn) Organisatie van de staalvoorbereidingen begeleiding en opvolgen van jobstudenten en andere collega’s binnen staalvoorbereiding;
Aanspreekpunt voor labverantwoordelijken en eerste lijn;
Opvolging van evoluties in staalvoorbereiding;
Profiel:
A2 of A1 opleiding met laboratoriumkennis/ervaring (graduaat/bachelor);
Ervaring of affiniteit met textielmaterialen is een pluspunt
Wat kan Jefferson Wells voor jou betekenen?
Als ambassador krijg je de kans om te groeien binnen internationale bedrijven waarin je een sterk netwerk kan opbouwen. Door een persoonlijke opvolging krijg je een kwaliteitsvolle ondersteuning in elke stap die je onderneemt. Tot slot geniet je van de mogelijkheid om jezelf persoonlijk en professioneel te ontwikkelen aan de hand van interne trainingen en opleidingen.
Heb je interesse in deze functie? Aarzel dan zeker niet en solliciteer nu met jouw cv!
When sizing an industry, one of the important steps concerns all the metal structure, the piping support and be able to design and calculate the structures. That why our partner is looking for his office department a Structural and Ducting Engineer.
Integrated within a team and reporting to the Design Office Manager, your mission will be to ensure calculation and sizing of steel structure and associate supports.
What are your responsibilities?
Provide correct design & calculations of metallic structures (including connections), piping and ducting and to ensure their conformity with client specifications.
Issue the design notes in conformity with the applicable codes and standards.
Design, review, check and approve the drawings.
Analyse & manage the technical difficulties met with the manufacturing and erection companies as well the eventual claims with clients and to try to bring the appropriate solutions.
Participate in selection of different technical solutions proposed by the design office.
Supervise works, reports and studies outsourced to specialized companies.
Establish technical follow-up and co-ordination between the different stakeholders &partners (design office, manufacturing and erection companies, …).
As part of a team, both internally with other functions and externally with the customer, participate to derive a cost-effective means of (new) product design.
Who are you?
You have a Master’s degree in Civil or industrial engineering.
Knowledge of calculation softwares and CAD environments (Robot, ESA-PrimaWin, StaadPro, Algor, …)
Fluent in both spoken and written English.
Knowledge of and strong interest in methods of calculations for structural steel and vessels using international software/codes
Ability to liaise effectively, work in team with and build bridges between other departments
Ability to think “out of the box”
What can you expect?
You will work in a small, dynamic and agile international enterprise with highly talented colleagues. You will receive a comfortable compensation package with good fringe benefits and the opportunity to grow and develop in your skills, competencies and career.
Vous êtes orienté contrôle qualité et laboratoire ? La rigueur est votre maître-mot ? Alors ce qui va suivre va vous intéresser !
Notre partenaire est activement à la recherche d’un technicien QC pour rejoindre son équipe. Il s'agit d'une société active dans le secteur pharmaceutique située à Bruxelles.
Quelles sont vos responsabilités ?
Vous analysez et interprétez ces analyses pour les matières premières, IPC, intermédiaires, produits finis et échantillons de stabilité
Vous garantissez le double-check des analyses de vos collègues et vous réalisez des maintenances d’appareil si nécessaire
Vous réalisez des études d’applicabilité par Karl-Fisher
Vous dirigez ou participez à des projets d’amélioration continue du laboratoire QC
Qui êtes-vous ?
Vous possédez un bachelier en chimie ou biochimie
Vous maîtrisez les techniques analytiques physico-chimiques telles que HPLC, GC, UHPLC, titration, UV, ….
Vous avez une expérience dans un environnement (c)GMP
Une première expérience dans une fonction similaire est un grand atout
Si vous êtes ouvert à travailler en pause, cela est un grand +
Que pouvez-vous espérer ?
Notre client vous offre un package salarial attractif complété d’avantages extra-légaux et l’opportunité d’évoluer au sein d’un groupe dynamique et innovant.
Si vous êtes intéressé, n’hésitez pas à me contacter, via [email protected]
Nous n’attendons plus que votre candidature pour discuter de votre projet professionnel.
When sizing an industry, one of the important steps concerns all the electricity and instrumentation part to be able to supply and control the installations. It is for this purpose that our partner is looking for an E&I engineer for his design office.
Integrated within the Engineering Department, your mission will be to assure the interface with the different technical teams, project managers, suppliers and clients regarding control & instrumentation and electrical equipment.
What are your responsibilities?
Analyse the client’s technical specifications and draw up base documents
Coordinate and control the establishing of drawings and P&ID’s.
Issue technical design master documents.
Create and follow up electrical consumers, instrumentation and control i/o lists.
Make electrical, wiring schemes and flowcharts and fill out instrumentation and motor data sheets.
Prepare other technical documents such as instrumentation hook-ups, reports for instrumentation & electrical material reception, etc.
Check the technical conformity of supplier’s equipment quotes.
Participate in inspections & receptions of equipment.
Master’s degree in Engineering in electro-mechanical and/or instrumentation field
Experience in an international industrial environment
Knowledge of database softwares
Knowledge of technical design and Control & Instrumentation / Electrical equipment
Good knowledge of English
What can you expect?
You will work in a small, dynamic and agile international enterprise with highly talented colleagues. You will receive a comfortable compensation package with good fringe benefits and the opportunity to grow and develop in your skills, competencies and career.
Vous êtes orienté contrôle qualité et laboratoire ? La rigueur est votre maître-mot ? Alors ce qui va suivre va vous intéresser !
Notre partenaire est activement à la recherche d’un technicien QC pour rejoindre son équipe. Il s'agit d'une société active dans le secteur pharmaceutique située à Bruxelles.
Quelles sont vos responsabilités ?
Vous analysez et interprétez ces analyses pour les matières premières, IPC, intermédiaires, produits finis et échantillons de stabilité
Vous garantissez le double-check des analyses de vos collègues et vous réalisez des maintenances d’appareil si nécessaire
Vous réalisez des études d’applicabilité par Karl-Fisher
Vous dirigez ou participez à des projets d’amélioration continue du laboratoire QC
Qui êtes-vous ?
Vous possédez un bachelier en chimie ou biochimie
Vous maitrisez les techniques analytiques physico-chimiques telles que HPLC, GC, UHPLC, titration, UV, ….
Vous avez une expérience dans un environnement (c)GMP
Une première expérience dans une fonction similaire est un grand atout
Vous êtes ouvert à travailler en 2 pauses (6h-14h/ 14h-22h)
Que pouvez-vous espérer ?
Notre client vous offre un package salarial attractif complété d’avantages extra-légaux et l’opportunité d’évoluer au sein d’un groupe dynamique et innovant.
Si vous êtes intéressé, n’hésitez pas à me contacter, via [email protected]
Nous n’attendons plus que votre candidature pour discuter de votre projet professionnel.
