The Responsibilities • Independently design and execute pharmacokinetic studies, analyze, and interpret data, and presenting findings back to project teams • Recommend and lead new strategies within the DMPK department • Apply your understanding of surgical techniques to provide mechanistic study support for our projects • Develop and implement state-of-the-art technologies
Skills and Knowledge Required • A degree in biological sciences or related discipline, PhD would be advantageous • Demonstrate experience with a range of in vivo DMPK models • Experience in the pharma or CRO industry with hands on experience of in vivo ADME activities in drug discovery support. This will include routine and mechanistic investigations to support the understanding of the clearance and disposition of new drugs. • Knowledge of the range of ADME and analytical methods available to drug projects • Be able to demonstrate the ability to collaborate and influence in a multidisciplinary team • Publication and presentation record • FELASA B Belgium personal license for in vivo work
Our Offer Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
The Responsibilities • The Documentation & Compliance Officer manages and coordinates the updates of the documentation for the Secondary Packaging & Artwork Operations. • The DC Officer makes sure the structure of the documentation is accurate. • The DC Officer gets the requirements for update from the Process owner and writes the updates of the process into the different documents, avoiding redundancies or gaps. • The DC Officer prepares the review and manages the workflow of review and approval of documents, ensuring the training documents are ready as well for sop effectiveness. • The DC Officer manages and coordinates the deviations including investigations & CAPA of the SPA Operations team. • The DC Officer works in close collaboration with the Operations team but also with the SPA Compliance Expert.
Skills and Knowledge Required • Bachelor's Degree • Knowledge of documentation & deviation management • Experience in packaging and preferably in the pharmaceutical industry is a plus • Data minded • Structured, detail minded and well organized • Ms Office advanced skills • Excellent at coordinating and tracking • Service minded with good written and verbal communication skills • Problem solver • Project Management skills • Stress resistant, flexible and team oriented • Capable of doing the extra mile to reach targets
Our offer Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. If you are interested, you can send your CV to [email protected] .
The Bioprocess analyst will be part of a team dedicated to performing in-process analysis of bioprocessess. This includes:
Plan and perform daily laboratory activities related to analysis
Performance of analytical assays with minimal supervision
Follow in-place procedures to guaranty data integrity
Analysis of results using advanced statistical methodologies and tools
Verification of data and troubleshooting when required
Prepare technical reports, process summaries, protocols, and quantitative analyses.
Utilize process and laboratory derived data to support technical investigations and aid in process optimization/development
Who are you ?
Bachelor degree in Biology, Chemical Engineering or related discipline with at least 1 year of industry experience in an analytical lab in a biotech environment.
Strong laboratory skills, experience working with monoclonal antibodies and a track record of spending >70% of current and past work function in the laboratory.
Proven experience working with HPLC, CGE and cIEF systems and Empower3 Software.
Ability to multi-task and to organize and communicate large amounts of data.
Flexible and the ability to work in a team environment under deadlines.
Interpersonal skills to communicate and maintain good working relationships with internal customers/partners across departments and geographies.
Ability to work in a matrix and service-oriented environment.
Ability to present and discuss orally and in writing scientific data in English
What can you expect ?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
Computer System Validation Engineer La mission est à réaliser au sein du département Site Process Validation de Braine L’alleud (Belgique) qui a pour responsabilités de prendre en charge les activités de qualification et validation du Site. La mission se déroulera plus précisément dans le pôle « Computerized System Validation » pour un projet transversal c’est-à-dire concernant toutes les BU. Le but étant de renforcer la politique de cybersécurité du site de Braine et en substance, à passer sur des systèmes d’exploitation Windows 10. De là, un assessment est réalisé afin d’évaluer la compatibilité des versions de logiciels/micrologiciels actuels avec cette nouvelle version de système d’exploitation.
Vos Responsabilités – Définir et assurer le suivi des stratégies de qualification CSV qui touchent au projet OMP, – Identifier l’approche d’implémentation de ces stratégies (Change Control, autres), – Déterminer les impacts validation sur base des release notes du fournisseur, – Évaluer la compatibilité avec les logiciels / micrologiciels existants, – Comprendre, appliquer et communiquer sur les prérequis de validation, – Identifier et contrôler les risques inhérents au projet, – Rédiger les documents de qualification conformément aux SOP de la société – Planifier, organiser et coordonner les activités de validation, en lien avec l’équipe projet, – Exécuter et/ou vérifier les tests de qualification des installations en impliquant les futurs utilisateurs et/ou le fournisseur et conformément aux procédures en vigueur, – Reporter à sa hiérarchie tout problème ayant un impact sur le planning d’implémentation ou le déroulement de la mission, – Supporter ou prendre à charge des activités liées à de l’amélioration continue, – Assurer le respect de la législation et des normes en vigueur ainsi que des règles de sécurité interne. Par ailleurs, la personne pourra compléter des périodes plus calmes par la gestion des activités de qualification/validation CSV liés au projet automation en cours (autre que ceux d’OMP), soit : o Définir et assurer le suivi des stratégies de qualification/validation CSV. o Evaluer l’impact qualification inhérent au risques identifiés. o Rédiger les documents de qualification conformément aux SOP de qualification /validation. o Identifier l’approche d’implémentation de ces stratégies (Change Control, autres). o Planifier, organiser et coordonner les activités de validation, en lien avec l’équipe projet. o Exécuter et/ou vérifier les tests de qualification / validation des installations en impliquant les futurs utilisateurs et conformément aux procédures en vigueur. o Reporter à sa hiérarchie tout problème ayant un impact sur le planning d’implémentation des dits projets éventuels. o Donner le support CSV aux activités du département Site Process Validation (gestion de déviations, CAPA, préparation et/ou participation aux audits, …). o Mettre à profit son expertise CSV afin de répondre à des sujets spécifiques (position papers, analyses de risque, …)
Les Connaissances et Compétences Requises – Bachelor / Master de préférence à orientation informatique/automation industrielle et autrement, dans un domaine scientifique. – 5 ans d’expérience dans le domaine de la validation dont au moins 3 ans sur les systèmes automatisés et/ou informatisés et en particulier sur des mises à jour / upgrade/ revamping de software / firmware. – Compréhension des flux, des pratiques, des méthodologies et des délivrables de validation. – Connaissance confirmée de la partie automation des procédés industriels pharmaceutiques (laveuses, testeurs de gants, RABS, isolateur, sertisseuse, remplisseuse, scelleuse, tunnel de dépyro, autoclave, testeurs de filtres, stations CIP/SIP, centrales d’acquisition comprimeuse, mélangeur, système d’inspection visuel, système de sérialisation). – Connaissance confirmée de la partie équipements de laboratoire (RMN, électrophorèses, spectro UV Vis, Spectro FTIR, qPCR, MALDI TOF etc.). – Connaissances des paramètres et éléments de conception pouvant avoir un impact qualité sur les procédés susmentionnés. – Connaissance des techniques en IT/Computer System Validation. – Compréhension et facilité d’expression en anglais. – Capacité à prendre des responsabilités et des décisions. – Capacité à entretenir de bonnes relations avec les acteurs du projet. – Capacité de persuasion et compétence d’assertivité. – Rechercher et analyser les causes de défaillances, et proposer des solutions innovantes pour y remédier. – Capacité à établir des liens entre les concepts et à faire preuve de recul (helicopter view). – Autonome et flexible. – Faculté à comprendre, à suivre et à faire siennes les décisions prises avec le line manager. – Esprit analytique et capacité de raisonnement logique marquée. – Méthodique, rigoureux, proactif et organisé. – Orienté(e) qualité et client (manager CSV). – Facilité à travailler en équipe et à soutenir ses collègues, à communiquer et à parler d’une seule et même voix. – Franchise, éthique, honnêteté, respect & intégrité. – Capacité à coordonner différents projets en même temps.
Notre Offre Si vous êtes passionné(e) par l'innovation et que vous souhaitez contribuer à un projet stimulant au sein d'une entreprise de renommée mondiale, postulez dès aujourd'hui à notre offre. Jefferson Wells s’engage à vous offrir un contrat en consultance, un accompagnement rapproché ainsi qu’un salaire et un package attractifs. Des questions ? Vous souhaitez soumettre votre candidature ? Envoyez un mail à [email protected] .
The Cellular Biology Scientist will be part of the cell biology team. The team is composed by scientists supporting the neuro-science preclinical projects from the beginning until they get the molecules ready for the clinical trials.
You will :
Work on the design of the experiments
Analyze and reporting the data’s
Setting up assays or screening methodologies to understand the mode of action of mo lecules
Use of human translational disease models
Check if the molecules have the desired therapeutic effect and the strength of the effect.
Work with stakeholders: the neuro-inflammation and neuro degeneration epilepsy team; toxicology department; chemistry department,…
Who are you ?
Master/PhD level scientist with experience in cell biology.
Background – in iPSC neuronal differentiations from iPSC – molecular biology techniques as gel electrophoresis, RT-qPCR, shRNA or guideRNA design and sequencing (scRNAseq, RNAseq)
Biochemical techniques as western blotting, Jess – setting up of quantitative mechanistic or phenotypic assays as ELISA, MSD, MEA
Data analysis capabilities using Graphpad, Excel, ActivityBase, Spotfire
Fluent in English
What can you expect ?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
Define and propose the qualification/validation strategy for equipment, systems, and processes, including development products, focusing on continuous improvement.
Align site validation strategy with industry benchmarks.
Support and update the Site Validation Master Plan (SVMP) based on management priorities.
Define relevant KPIs for managing “Site Process Validation” activities.
Operations:
Provide SME expertise in Qualification/Validation for evaluating and approving protocols and reports.
Plan and organize Qualification/Validation activities related to the SVMP with the system owner.
Stay updated with technological advancements and maintain technical expertise.
Develop and maintain procedures for the Site Process Validation Department.
Foster partnerships with clients and suppliers to improve process control.
Develop the skills of Business Unit employees for agility and flexibility.
GMP and Quality:
• Ensure documentation consistency with strategies and methods per current requirements. • Defend Q/V activities during internal and external audits. • Report quality-impacting issues to management. • Make decisions on qualification strategy deviations with SMEs.
Who are you ?
Experience of 6 to 8 years in the field of Qualification and/or validation is essential and more particularly in the field of chemical and pharmaceutical synthesis, Laboratory equipment and warehouse
Proven experience in team management, qualification, production, pharmaceutical industry, and CVS is a plus.
Good knowledge of English and French is mandatory.
What can you expect ? Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
Performs analyses like X-Ray Powder Diffraction, SEM, Optical microscopy, Spectroscopy (Raman, IR), DSC, TGA, DVS,… to characterize the solid state of compounds (polymorphs, amorphous) on pure material or in mixture, and formulated material (suspension, blend, granules, tablets, amorphous solid dispersion).
Provides solid-state support for development projects at preclinical and early clinical stages, which implies polymorph studies, salt and co-crystal screening.
Develops when appropriate qualitative or quantitative methods in the above-mentioned fields with support of experts.
Performs solubility curve measurement and support to crystallization process.
Interprets data in the context of solid-state analyses.
Documents and verifies in an appropriate manner the whole of the performed activities (e.g. Electronical Lab Notebook, sample management system, …).
Contributes to the writing of technical documents like reports, user guides, guidances, etc…
Does short presentations of results to experts.
Reads documents in English and writes (draft) reports in English.
On equipment, performs calibrations and other necessary verifications in agreement with procedures and reference documents and assures the integrity and the maintaining of proper functioning of the instruments.
Applies the health safety and environment policies and rigorous standards (GMP, GSP, 5S) of the laboratories.
Quality:
Makes sure to have received and understood all the information and instructions required for the tasks before starting work.
Communicates appropriately the results and any event that might have a potential impact on the quality or timelines of the activity, to the supervisor or other concerned people.
Respects the procedures and reports any discrepancies to the responsible.
Respects and properly maintains the analytical equipment and facilities at his/her disposal.
Performs double check within the team.
Shows good communication skills/teamworking skills.
Who are you ?
Min. Bachelor in (bio-)chemistry and/or analytical chemistry or equivalent.
Min years’ experience required: 2-3 years at least in analytical laboratory. Pharma background or solid state background may be an advantage.
Key technical backgrounds: Experience in XRPD and spectroscopic techniques.
Mandatory skills: team player, compliant/rigorous (understands the importance of following procedures), meticulous, patient, flexible (needs to combine multiple tasks and must adapt to priority changes).
Language skills:
Fluent in French
English: able to read scientific documents and write draft reports
What can you expect ?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
Supervision of Transport Requests, Product Shipment Execution, Post-delivery Service, ensure the achievement of agreed service levels, costs and compliance regulations
Preparation of all shipping, import and export documentation as required dependent on relevant flow.
Initiate cross-functional collaboration to drive service improvement, forecasting accuracy and replenishment management as well as support and implement growth strategies, duly but not limited to New Product Introductions order management and execution.
Complaint/Deviation supervision in Trackwise/Source system, accountability for relevant CAPAs
Handle complex and escalated order management constraints and Creation and management of deliveries and shipment transactions in SAP.
Analyze relevant data to determine order management outputs and handling of operation administrative tasks.
Responsible for the dangerous goods sent by road or airfreight as per the ADR/ IATA regulations as well as working knowledge of GDP shipping.
Work with transportation providers and ensure proper volume and cost allocation.
Managing SOPs and associated documents for Global Transportation. Implement Global Logistics policies and procedures – partner with related functions seeking for process formalization and improvement
Partner with GTDC to monitor performance for enhanced Supply Chain resilience (e.g. Import and Exports Controls, Valuation, Temperature monitoring)
Manages and solves upcoming risks efficiently and identifies root causes
Initiates any additional change controls that may be needed in the context of launch and linked to distribution topics and have an active participation in Global Distribution Projects and Launches
Identify and implement Continuous Improvement initiatives to improve quality of service, productivity and profitability – in partnership with Global Distribution Excellence
Key stakeholders for liaison
Internal: All Global Distribution pillars; GSC functions (Affiliate Regional Managers, Affiliate and Regional Finance Managers/Controllers, Regional Supply Chain, Plan), IM and Site Supply Chain Management and Global Purchasing • External: Service Providers/Vendors, in particular 3PL’s, 4PL’s, carriers, Customs Brokers, various branch organizations for transport and logistics managemen
Who are you ?
Bachelor's Degree
LEAN management
At least 3-5 years relevant working experience in international pharmaceutical logistics management and/or supply chain expertise with excellent understanding of GDP (European and International). ADR/IATA certified. Practical experience in cooperating with FCA, usage of DETEC platform.
Understands basics of supply chain flow & concepts from long term demand to distribution to the patients (tools, terminology, and techniques)
Understands the importance of accurate and comprehensive master data and GxP rules
Working knowledge of GMP/GDP regulations, implementing procedural control frameworks, and experience with audit/inspection protocols.
Knowledge of Incoterms and Cold Chain Distribution
Ability to manage the “grey zone”, balance multiple priorities
Fluency in English and French
What can you expect ?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
To strengthen the Biological Formulation department, our client based in Braine l’Alleud, is looking for a talented individual to fill the position of: Formulation Development Scientist. As a Formulation Development Scientist, you will be responsible for the selection of formulations allowing the NBEs to move forward from preclinical, clinical and commercial stages.
The Responsibilities • Supporting the development of formulation of monoclonal antibodies through the application of manufacturing (buffer exchange) and analytical techniques (H/UPLC, cIEF, UV spectroscopy, DLS, CGE, etc.). • Preparing formulations of antibody for stability studies and collecting experimental data following established analytical methods. • Writing accurate and precise experiment records, for all activities following Good Scientific Practices. • Helping to generate study protocols and reports to justify the selection of preferred NBE formulations.
Skills and Knowledge Requirements • Biotechnology, Biology or Analytical (bio)chemistry degrees. • Ideally 2 years of industrial experience, experience with analytical techniques and/or formulation, ideally with proteins/antibodies derived molecules or at least an internship with practical experience. • Practical laboratory skills with HPLC/UPLC (especially size exclusion), cIEF, UV/Vis spectroscopy, DLS, CGE, rheology, etc. • A working knowledge and practical laboratory experience of antibodies and their formulation, including freeze-drying. • Experience or interest in protein structural modelling is a plus • Experience in writing accurate and precise experiment records • Experience with data analysis and interpretation, protocols and summary report writing would be a plus. • Technical English is mandatory. • Familiar with a creative, flexible, fast pace and stimulating environment in a multidisciplinary team.
Our Offer Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
The Responsibilities • Is accountable of the design and execution of his projects – mainly in management of some different projects/program (multiple/interaction management of dashboard, status advancement and health for each project/program). • Coordinate and manage activities with partner (engineering company) during projects design & execution (all portfolio of projects/program will be produced with Engineering company). • Coordinate all technical activities and planning for execution of a project. • Have a larger understanding of all related disciplines to challenge/review globally and identify potential issues. • Have a relevant or previous experience in Pharma (rules GXP, GMP or GLP) and have expertise in Intregrate (Planisware SW) Infrastructure, Security or Annex 01 is a must. • Is also person of reference of overall project activities – cost, schedule, quality, risk mgmt, Gate mgnt,… • Project point of contact with management, business clients, external or engineering companies and technical team. • Alignment with global standards – technical, green, safety, GMP, … • Partnering with engineering firms to ensure proper support in delivering the project designs & execution. • Working with our Business Expert to define the best solution to meet customer needs. • Managing cost and planning for all engineering projects activities. • Managing Basic / Detailed design and execution. • Ensuring resources identified without gaps nor overlap. • Handling project governance, budget controlling in accordance with PMO requirements (dashboard of multiple projects). • Overseeing the project team supervision (with Engineering company) • Consolidating and reviewing specifications (e.g., URS, Technical Specifications) with team project members and Engineering company. • Ensuring strong communication with stakeholders and Engineering company. • Supporting the communication structures for full collaboration between all parties involved in engineering projects to ensure two-way communication, engagement, and collaboration. • Dealing project engineering package of medium to high complexity.
Skills and Knowledge Requirements • Ability to take initiative and work in a team environment. • Strong value commitment. • Experience in (complex/multiple) projects. • Both formal and informal leadership / coordination. • Experience with deployment of EPC (Engineering, Procurement and Construction) and EPCM (Engineering, Procurement and Construction Management) contracting models. • Manages with a matrix of reporting lines and across functional areas. • Ability to share good practices and knowledge. • Excellent communication skills and ability to prioritize multiple tasks and to work on multiple projects simultaneously. • Leadership experience for the management of internal and external resources. • Ability to apply previous learning and ideas to new situations, projects and teams, developing creative solutions to manage risk to a reasonably practicable level. • Strong reporting, interpersonal and leadership skills. • Able to translate customers’ needs in projects requirements. • Full professional proficiency in French and English (both oral and written).
Our offer Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
