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 process vision engineer will be a skilled professional that will work within the vision team, along with the other vision experts. In this position, he or she will be responsible to maintain and improve the automated visual inspection program as well as the robustness of other vision systems.
As a technical expert, he (or she) will also have to build and to manage technological knowledge for Automated Visual Inspection linked to manufacturing processes into the Production unit for syringes and/or vials. He (or she) will:
Assure proper functioning of Automatic Visual Inspection Machines in the Production unit.
Fine tune / develop new or existing vision programs to decrease false rejects or to improve detection capabilities.
Interact with production, Quality and global vision experts.
Lead and/or participate to technical investigations in case of atypical false rejects rate with the vision team, production supervision, Quality and maintenance team.
Provide vision expertise to support maintenance activities.
Develop technical knowledge in AVI with the support of local and global experts and supplier and supports field technicians as well as production performance.
Participate to the continuous improvement process performance (simplifies processes, design a short and mid-term strategy for the programable contents, lowers the false ejection rates)
Lead investigations and trials related to process improvement for vision (on the AVI machines and on the upstream process). Propose (and integrate) solutions for improvement.
Respects current Good Manufacturing Practices (CGMP) as well as GMP procedures.
Provides technical support to the deviation handling process (root causes identification and of CAPAs task execution in order to avoid recurrence of deviation with technical root causes).
Skills and Knowledge Requirements
Education : Industrial engineer (or similar level of education)
Knowledge : Automatic visual inspection, Vision systems (not necessarily linked to pharma), automated system programming.
Language : English and French.
Experience : 3-5 years' experiencein a similar function
Able to work in team in a production environment
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.
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.
Execution of project management activities, including
Contract management for external parties
Managing project scope
Managing project planning (resources and material)
Controlling time management and monitoring progress
Drafting and controlling project budget
Analyzing and managing project risks
Governance & Reporting
Putting in place an effective governance
Managing reports and other necessary documentation
Ensuring internal and external stakeholders’ satisfaction
Leading project’s meetings
Coaching, mentoring and knowledge management
Organizing and motivating a project team
Developing project management best practices
Managing integration of the team’s work to the strategic objectives of the company
Drafting and sharing lessons learned
Who are you ?
A Master’s degree in business, engineering or life sciences is highly preferred.
5 years of experience in a Project Management role, or related function, within Pharmaceutical Industry or its providers. Previous experience in R&D projects is a plus.
Experience of working with global, multi-cultural, diverse, cross-functional project teams, with demanding timelines and complex deliverables
Project Management Certification or Qualification is an asset (PMP, Prince 2, Agile …).
Fluent in English. Fluency in French is a big plus.
Thorough familiarity with word processing, spreadsheet, and project scheduling computer applications.
Ability to manage multiple priorities under pressure, trouble-shoot, and to meet short- and long-term deadlines.
having a customer-centric approach when managing client projects
Agility to transition on an easy way between internal R&D and client/customers R&D projects.
Demonstrated experience in budget and financial management.
Excellent written and verbal communication skills.
Excellent critical and creative thinking.
Ability to build a trusting and safe environment where problems can be raised without fear of blame, retribution, or being judged, with an emphasis on conflicts and problem-solving.
Providing all support to the team using a servant leadership style whenever possible and leading by example
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.
• Responsible for the coordination of the validation of small projects linked to eCC Secondary (Formulation or Filling) related to equipment such as freeze dryer, autoclaves, oven…or CIP, SIP, Mediabulk, Mediafill, Mediaform or utilities (EDI, EPI, EUF, VP, ACP, N2) or process control/automation equipment. • Responsible for defining and implementing an adequate validation strategy in compliance with FDA, EMEA and International quality standards. • Responsible for ensuring and coordinating the support (planning, weekly validation, resources, cost) to RPCs or projects. • Review and approve protocols and certificates for IQ/OQ/PQ and check-lists. • Manage deviations and out of specifications: bring expertise and help in investigating and solving issues. • Ensure correct and state of the art Validation approaches for eCC from Design Qualification step to the establishment of the Qualification Summary report (which is final approved by the QA). This accountability involves knowledge of the Validation Life-cycle process as well as in Specific Validation Strategies (i.e.Cleaning Validation, Aseptic Media Simulation…) • Responsible for assuring inspection readiness – regarding Validation – by Corporate functions and RA authorities (FDE,EMEA,Canada). Make sure that drawings and core files are updated. • Has developed at least one area of expertise and is recognized as such. • Bring expertise and coaching to streams • Project Management: control/monitor cost and planning. Take corrective actions if necessary. • Ensure coordination with all key players (local QA, Global QA, • C&M, Streams rep…)
The skills and Knowledge Requirements
Must Haves: – University degree in sciences – Validation – Change control management – At least 5 years’ experience in Supply Chain activities (production, – QC, QA) in a global environment. – GMP knowledge – Knowledge of regulatory – Knowledge of Bio processes – Knowledge of Bio vaccines
Nice to haves: • Green belt or project management certification is an asset • Validation expertise • Change management • eCC expertise • P&P or similar experience/expertise.
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]
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]
