Support preclinical projects focused on the central nervous system (CNS) by developing disease-relevant biochemical and cellular screening assays.
Provide relevant and high-quality data in a timely manner to support project goals.
Study and understand the mechanisms of action of advanced compounds to select the best candidates for clinical trials.
Utilize cutting-edge instruments and technologies available internally or through external collaborations.
Responsibilities:
WORKS PREPARATION
Accountable of the site accommodation area with the SME & subcontractor (Space, Flow – Human / Waste / Raw mat, Power, Access),
Consulted for the construction phase matrix with the Engineering Lead (Phase / HSE material / Transport system),
Ensures the good reception and follow-up of legal and required the company's documents
Realizes the site display, ensures the declaration of works at ONSS
Initiates the various monitoring tools of the project
Ensure all ‘’base de vie’’ requirements are respected
WORKS SUPERVISION
Command the works execution on a daily basis to be completed as scheduled in the level 4 planning
Identify potential work delivery deviation ( short and long term schedule, material quality, …), identify impacts and communicate proactively with the team
Responsible to do the monitoring of site project (via Progress Report)
Communicate proactively with the SMEs during their contractors works
Approves the contractor’s “work log”
Do and document ‘’checking at work’’ spot checks
Insure the fulfilling and the signature of the “Official Works Declaration” (to ONSS)
COMMUNICATION WITH STAKEHOLDERS
Participate in the weekly technical coordination meeting of the project
Communicate to the Engineering lead any activities delays or observed execution problems
Give feedback to the Engineering lead or / and SME on the field activities progress
Participate in the project closing and share his project feedback
Attend to the weekly “Site Interaction” meeting.
COMMUNICATION WITH STAKEHOLDERS
Ensure good coactivity between all subcontractors in supporting the “Health Safety Coordinator” trough his missions (“PSS” & “PPSS”)
Actively participate to risk analyzes (JRA / PLCA / LOTO, …) related to the works of the engineering department with the project stakeholders
Ensure that the company requirements, including HSE requirements, are met by contractors
communicate any infringements to the direct hierarchy. Use authority and penalties in accordance with the decision matrix in the HSE General regulation for external companies
Perform a work weekly audit to evaluate works conditions (level 1)
Ensures that the contractors respect the building site boundaries
Performs general inspection to evaluate the tools state in use by the contractors. (Scaffolding, electrical equipment, work plan, …)
Ensure that all permits are opened daily for each subcontractor and that the scope is clearly defined and the HSE measures selected
Ensure at the end of each day that all permits are closed and that the planned work is completed in accordance with the defined perimeter
Transfert all permits related to the projects to HSE department procedure
Checks the “Safety Pass” belonging and approvals in the field
Profile:
Bachelor's degree
Minimum 5 years of experience in relevant experience
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.
Support preclinical projects focused on the central nervous system (CNS) by developing disease-relevant biochemical and cellular screening assays.
Provide relevant and high-quality data in a timely manner to support project goals.
Study and understand the mechanisms of action of advanced compounds to select the best candidates for clinical trials.
Utilize cutting-edge instruments and technologies available internally or through external collaborations.
Responsibilities:
Be part of a team dedicated to implementing and executing screening assays relevant to CNS diseases.
Identify new compounds and support lead optimization, candidate selection, and characterization.
Provide scientific support and high-quality data under the supervision of experienced scientists.
Proactively suggest new steps and continuously seek to optimize processes during the development and execution of screening assays.
Actively explore new methodologies and technologies to improve assays.
Profile:
Experience and Technical Skills:
Master’s degree in biology, pharmacology, biomedical sciences, biotechnology, or a related field.
Skills in quantifying and analyzing pharmacological data using Excel, GraphPad Prism, or similar tools.
Proficiency in cell culture, including established cell lines and primary cells.
Strong knowledge in screening sciences: assay automation, miniaturization, and handling screening instruments.
Education and General Skills:
Master’s degree with preferred experience in a biopharmaceutical and screening environment.
Open-mindedness, laboratory rigor, adherence to compliance and deadlines.
Excellent communication and interpersonal skills, necessary for frequent interactions with colleagues and external collaborators.
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.
To strengthen our client’s Regulated Bioanalysis Development Sciences team, we are looking for a talented individual to fill the position of Scientist Regulatory Bioanalysis. The position is based in Braine l’Alleud.
The Responsibilities • Be responsible as a lab-based scientist for effective method validation and sample testing activities across multiple projects in the Immunology and CNS therapeutic portfolios • Dunning validation, and sample testing experiments. • Delivering needs for pre-clinical and clinical studies • Work with method development scientists for the successful transfer of assays. • Maintenance of the GLP quality system as well as being involved in optimizing and reshaping the quality system as a function of new activities, /workflows being implemented.
Skills and Knowledge Requirements • Master’s degree with a minimum of 3 years of experience as a Bioanalytical Scientist with a proven track record in method validation and sample Testing in support of bioanalytical study phases. • Experience working in regulatory environment (GLP/GCP) where the quality is paramount would be critical. • English, both spoken and written (French will be considered as a major advantage) Bioanalysis • Extensive hands-on laboratory experience in LC-MS validation and sample analysis • Preferably good knowledgeable in PK analysis following IC-M10 using LC-MS • LBA experience is a plus Regulatory landscape coverage • Extensive knowledge of GLP/GCP guidelines as applicable to bioanalysis • Extensive knowledge of bioanalytical method validation guidelines • Experience as principal investigator in pre-clinical and clinical studies IT knowledge • Experience using Watson LIMS or equivalent LIMS system • Good knowledge of Microsoft Office • Graphpad/JMP experience is plus
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]
In this key role he/she will serve as the Pharmacometrics Expert, working within a matrix team supporting early (pre-POC) and late phase (post-POC) projects to deliver and apply quantitative solutions to drive the delivery of the translational and clinical development plan. Working outside the CST/PST framework with key individuals (Quantitative Clinical Pharmacologist, Statistician, Biomarkers and Therapeutic Experts) to scope the key question/concept, plan a solution, and lead its execution and delivery, providing an answer. You will provide specialized (and recognized) advanced modelling skills to multiple projects, and will work within a dedicated team, enhance project impact, develop and apply new methodologies and solutions, whilst remaining at the cutting edge in terms of expertise.
The Responsibilities
Accountable for scoping and delivering the Pharmacometrics components of assigned projects
Developing disease-based PK-PD models and meta-analyses to support translation, risk assessment through various decision points (candidate selection, FIH, POC to PH3) e.g. RA, Psoriasis, Parkinson’s Disease, Alzheimer’s and Epilepsy
Providing analyses to support the recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc) to the clinical and Development teams and in regulatory documentation.
Accountable for providing advanced mechanistic modelling support for evaluation of key assets, prior to candidate selection.
Provide guidance to the quantitative pharmacologist on optimal PK and PK-PD sampling for implementation in the various stages of development, and subsequently perform the population PK, PBPK and PK-PD analyses (safety and efficacy) on a continuous and live basis as the project progresses.
Accountable for the Pharmacometrics activities to support the design and analysis of early phase (to POC) by delivering a translational and quantitative framework for use within the clinical development team, with the purpose of conducting clinical trial simulations to evaluate design, dose and regimen selection, sample-sizing and optimal delivery of key decisions (e.g Phase I b or II doses and regimen).
Provide a quantitative evaluation of the potential for DDI in the clinical setting using approaches such as PBPK, to support therapeutic dose choice, and assessment of project risk.
Provide expertise in the evaluation and prediction of receptor occupancy/target engagement.
Evaluate the potential use of different technologies and approaches to support project progression e.g. empirical approach, systems pharmacology, sparse methodology
Accountable and responsible for key technical reports (e.g. population PK, PK-PD, trial simulations as well as sections of regulatory documents).
Mentor and coach junior pharmacometricians including review of the strategy, technical code and documents.
Skills and Education Requirements
Functional scientific skills, including:
Physiological and biochemical understanding
Mathematical/statistical skills
Therapeutic Expertise
Experience in pharmacokinetics/pharmacodynamic modelling
NonLinear Mixed Effects Modeling
Knowledge of drug development and the application of modelling in the regulatory and decisionmaking setting
Super-User software proficiency in performing data analysis and interpretation within softwares such as:
Pheonix
R or SAS
MatLab
Berkeley Madonna
Monolix
NonMem and addons (Census, PsN, XPose, WFN….)
The role holder brings to the expert group, a specialist and recognized advanced skill set that can be tapped on and is available to multiple projects. Key pharmacometrics skills are required to evaluate the implementation of novel and innovative methods of key pre-clinical and clinical data for decision making.
Our Offer 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.
The Responsibilities Operational 1. Manage staff qualification process to ensure compliance inside CMC Dev (creation/update of training matrix, training plan,) 2. Update documents (sops, process, assessment, slides …) identified in project and impacted by OPM 3. Participate to assessment for OPM and support the CC 4. Support compliance activities 5. Interaction transversal entities and stakeholders in and out CMC Dev Sciences 6. Read and write in English Quality 1. Make sure to have received and understood all the information and instructions required for the tasks before starting work. 2. Respects the policies and procedures in place for QMS at the company.
Skills and Knowledge Requirements • Experience project Management and compliance • Experience staff qualification and training process • Master/Bachelor: Biology, chemical, … • Min years’ experience required: 2-3 years • International experience a plus • >3 years of industrial experience in pharmaceutical development preferably with roles in compliance or training Management • Experience with preparation of business processes audits • Good knowledge of learning principles and associated Tools (VeeVault , Talenshare, Pyton ,..) • Ability to build partnerships internally and externally • Good Leadership, collaboration mindset and communication skills • Resilience and ability to lead and influence people • Excellent planning and organizational skills with the ability to prioritize according to company priorities, Compliance and Patient Safety risk • Project Management skills • Language skills: o English: Good level o French: mandatory/fluent
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]
Automation Engineer Contracting – Braine l’Alleud The Responsibilities
Verify project documentation coming from Engineering Company and Automation Integrator.
Challenge process design to ensure alignment between equipment.
Participate and define overall automation strategy for our new BioManufacturing Plant (Library, Recipe structure, HMI philosophy, reporting, alarm strategy, etc.)
Manage the team of Engineers to deploy automation strategy.
Follow ‘up Automation Integrator and Vendor Packages during development and execution.
Verify automation deliverables and anticipate any cost increase.
Proactively report and manage risks.
Organize operator training.
Perform handover to operation and support team.
Manage punch list related to its packages.
Translate process improvement / modifications into automation requirements.
Ensure efficient handover to operation teams and ensure they will be trained to operate the automated installation.
After handover be part of the Automation Engineering local team and support manufacturing activities (24/24 guard)
Support and troubleshoot installations to guarantee process Drug Substance manufacturing.
Skills and Knowledge Requirements
Minimum 5 years’ experience in Bioprocess and/or Automation
Proven involvement in significant major engineering projects, including risk/mitigation management.
Goof level of French and English
Strong knowledge of cGMP
Strong knowledge in design, execution, and C&V
Ability to translate and present expert concerns to facilitate decision.
Ability to work in highly dynamic environment and to handle challenging situations.
Able to reach team decision and high sense of responsibility.
Ability to challenge and argument.
Ready to travel a limited period of time.
Our offer 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.
Develop and validate analytical methods to support projects in development in different phases of product development.
Perform analyses of raw materials, intermediate products, in bulk or packaged finished products in accordance with work instructions and established procedures (stabilities, in-process control, clinical release, investigation, …).
Ensure stability analyses and clinical release for clinical phases I and II, as well as any analyses in support to process understanding (IPC test, forced degradation study, multimedia dissolution, …)
Analyze results with readiness to criticize and ensures the consistency of these results with earlier data if relevant.
Participate to analytical exercise transfer to QC and subcontractors.
Monitor the documentation associated with the analytical laboratory activities by mastering the computer softwares in use at the laboratory (eg Mikado, GLIMS, e-noval, TrackWise, …).
Quality
Make sure to have received and understood all the information and instructions required for the tasks before starting work.
Respects the procedures and reports any discrepancies to the responsible
Use authorized and validated methods prior to testing, if applicable.
Respect and properly maintain the analytical equipment and facilities at disposal.
Performs double check the team.
Skills and Knowledge Requirements
Master or Bachelor: analytical chemistry
Key technical backgrounds: small molecule chromatography (HPLC/UHPLC/GC) and detection techniques (UV/Vis, MS), USP/EP Pharmacopoeias
Mandatory skills: team player, exp. in a similar position/environment, compliant/rigorous (understands the importance of following procedures in detail)
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]
As a Clinical Drug Delivery Device Lead, you will report to the Head of Device Transversal Services and you will work as a subject matter expert to select and/or assess drug delivery devices used in clinical trials (ie. injection pumps, infusion lines and bags, needles and syringes for iv and sc administrations, oral syringes and dosing cup, etc…). You will be part of a global and highly collaborative multidisciplinary team. What you’ll do
Define and implement the overall strategy for the various drug delivery devices to be used in the clinical trials.
Work with a cross-functional team (including clinical, QA, RA, safety and SME teams) to ensure timely support to clinical trials.
Lead the Clinical Drug Delivery Devices sub-teams to ensure appropriate selection and assessment of drug delivery devices to be used in the clinical trials.
Perform the technical assessment for devices used in clinical trials and selected by our CROs.
Who are you ?
A master’s degree with a relevant academic background, ideally a nurse or a physician
8+ years of experience in a clinical drug delivery devices selection
Very good knowledge of medical devices and pharmaceutical environments
Experience in clinical trials set-up
Understanding of the issues and challenges of selecting appropriate and fit for purpose devices from FIH to Phase 4 clinical trials studies
Thorough knowledge and understanding of Medical Devices Regulations (EU MDR, 21CFR part 820, ISO13485) and in GxP (GMP and GCP)
Experience in drug-device compatibility testing and material of contact assessment is a plus
Project management skills
Leading and influencing cross-functional and matrix teams
Excellent writing skills
Autonomous and detail oriented
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.
Gérer et coordonner en support avec la production leader les activités de production.
Être le back-up du production leader en cas d’absence, et participer au rôle de garde.
Support opérationnel pour la réalisation des activités de production en cours.
Prendre en charge et définir les actions immédiates liés à des dysfonctionnements ou anomalies observées en cours de production.
Revoir, analyser, avoir un “œil critique” et communiquer les résultats de production en cours afin d'identifier toutes anomalies ou déviation.
Identifier et prendre en charge les investigations, les déviations et les définitions des CAPA pour résoudre durablement des problèmes rencontrés lors des activités de production.
Identifier, proposer et prendre en charge des actions d'amélioration continue afin d'optimiser les opérations de production.
Préparer et présenter des sujets lors des inspections internes et externes
Leader et/ou participer aux projets liés aux activités de production (support Tech Transfer, process validation, CPV,…).
Assurer que les équipements et la zone permettent d'effectuer la production en accord avec les règles cGMP et HSE (equipments qualifiés,calibrés et maintenus)
Assurer la transmission transversale des informations et escalader les problèmes critiques au sein de l'organisation de production.
Se coordonner et collaborer avec les autres bio manufacturing leads (USP, DSP, logistique) afin d’uniformiser les pratiques de gestion et suivi entres les secteurs de production.
Ouvrir / suivre / clôturer dans les temps impartis les déviations qualité de la production.
Ouvrir / suivre / clôturer dans les temps impartis les changes control liés aux activités de production.
Création/maintien/analyses des fichiers de suivi des données de production (data mining).
Être le point de contact de la production pour les différents conseils en place (HSE, quality, C&V council).
Participer à la réalisation des activités de qualification des nouveaux équipements selon les normes GMP et standards définis.
Participer / gérer des activités de mise en place/amélioration/maintien fonctionnelle des zones de production.
Identifier les risques lors de l’exécution des activités (HSE, qualité, coût, timing, …), et les reporter aux responsables.
Supporter toutes les activités techniques et administratives nécessaire à la production selon le besoin
Préparer et présenter la documentation nécessaire lors des inspections d’autorités internes et/ou externes.
Expérience et Connaissances Requises
Expérience en production pharma/biotech en milieu GMP
Expérience en qualification/validation d’équipement
Bonne connaissance des systèmes automatisés
Expérience en production biotech ou pharma
Bonne connaissance des GMP et réglementations
Faire preuve d’un très bon esprit d’équipe
Savoir se montrer autonome et pro-actif
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] .
We are looking for a Manufacturing Sciences & Technology (MSAT) Lab Scientist who is dynamic, experienced, and collaborative to join our Global Biologics MSAT team, based at our campus in Braine-l’Alleud, Belgium.
The Responsibilities
Conducting cell culture experiments (including cell expansion, mAb production in glass and single use benchtop bioreactors)
Providing cell culture lab support for Technology Transfers, Process Validations, Manufacturing operations and deviations/investigations as required, by execution of appropriate cell culture experiments within MSAT.
Working with the MSAT Lab team to deliver cell culture milestones.
Establish close partnership with development and commercial manufacturing groups worldwide, serving as a representative of the department in cross-functional project teams.
Adhere to the company’s Health, Safety & Environment (HSE) policies.
Coordinate, design, and execute lab experiments applying Quality by Design standards and resources.
Ensure accurate documentation of experimental protocols, data, and reports.
Support the development and update of MSAT lab policies and procedures.
Provide cell culture lab support for technology transfers, process validations, and manufacturing operations.
The Skills and Knowledge Requirements
An M.Sc. degree in Biology, Biotechnology, Chemical Engineering, or a related discipline
A track record in cell culture activities
3 – 5 years of experience in cell culture
Excellent problem-solving and communication skills
Fluency in English is mandatory, with knowledge of French being advantageous.
Our Offer 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.
