To support activities for defining and selecting drug product manufacturing processes and components for clinical manufacture
Design and execution of lab studies in relation to drug product development activities, capture and analyze data and author related documentation (write-ups, protocols, reports (eg filter selection and sizing, target fill volume assessment, compatibility assessments, clinical blinding, etc)
Capture and analyse critical manufacturing process data for process understanding and process characterization
Perform process risk assessments
Design DP processes for sterile injectable drug products in liquid or lyophilized powder form, in vials, pre-filled syringes or as combination products),
Define the investigational medicine product preparation process in clinical trials.
Provide support to ensure timely manufacture of stability and clinical DP batches.
Provide support to process performance qualification/validation Ensure products are manufactured in accordance with quality system, cGMP and latest regulatory requirements.
Provide support in the completion of the relevant sections of the CMC regulatory submissions and regulatory briefing documents and response to questions from authorities.
Provide support in investigations of deviations and complaints related to DP quality.
Support knowledge transfer from late phase development to commercial for validated DP processes.
Contribute to develop the ways of working in the department
Your profile:
Bachelor’s degree in Sciences
Minimum 2-3 years’ experience in liquid drug product development and/or manufacturing within the pharmaceutical industry is required.
Experience within the biopharmaceutical industry is an advantage
Knowledge and technical experience in parenteral liquid drug product development and cGMP manufacturing under aseptic conditions (such as vial, cartridge and pre-filled syringe filling) is an advantage
Technical knowledge of sterile DP development covering DP components, process transfer, scale-up and optimization is an advantage.
Scientist grade
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. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Ensure the organization, maintenance and lifecycle management of controlled documents and training materials
Ensure compliance with applicable regulatory frameworks (GLP, GCP, Research Guidance, HTA, HBS, HSE, etc.) and internal standards
Process harmonization and continuous improvement
Support the design and implementation of streamlined, harmonized processes that integrate documentation and learning activities
Contribute to continuous improvement initiatives aimed at enhancing efficiency, simplification, compliance and user experience
Promote best practices and innovative solutions in documentation and learning management, fostering a harmonized, customer-focused, and outcome-driven culture
Act as the coordinator for the Regulated/Non-Regulated/Controlled Document management system, ensuring timely tracking, updates, reviews, and approvals of SOPs, guidance and related documents (based on regulatory changes, SME inputs, inspection finding or scheduled reviews)
Provide expert guidance to document owners and Patient Solutions staff on controlled document management best practices.
Ensure effective training and communication related to new or revised SOPs & associated documents, including timely withdrawal of obsolete documents
Training coordination
Support Patient Solutions employees and managers in meeting training requirements by maintaining accurate training plans, curricula and matrices
Ensure the availability and accessibility of training materials linked to controlled documents impacting Patient Solutions
Collaborate with the department learning lead and line managers to develop and maintain relevant training programs (plans, matrices, …).
Manage training records and documentation, including CVs, job descriptions, attendance logs, training registers, ….
Stakeholder engagement and support:
Serve as a key point of contact for all Learning & Documentation-related questions.
Manage and respond to requests received, including through the global PSol Learning & Documentation mailbox.
Audit & Inspection Readiness
Ensure operational readiness for internal and external inspections and audits related to documentation and learning.
Track and follow up on actions resulting from audit or inspection findings.
Performance Monitoring & Reporting
Collect, consolidate, and report key performance indicators and metrics related to documentation and training compliance.
Maintain and update the Learning & Documentation compliance dashboard.
Additional operational support
Provide support as needed to the Head of Internal Coordination, Learning & Sustainability Compliance in managing and reporting on broader initiatives, including sustainability, compliance, communication, intranet content, PMO dashboards, and objective tracking
Who are you?
Relevant experience in GxP (GLP, GCP) regulations and within the pharmaceutical industry
Relevant experience in SOP /training and content management systems
Familiar with electronic document management systems (e.g., Veeva, SharePoint, or similar platforms) and Learning Management Systems (LMS) for training assignment, tracking, and reporting.
Languages skills: French and English
Proficiency in Microsoft Office suite (Word, Excel, PowerPoint)
Ability to collect, analyze, and develop visual reports, KPIs and compliance metrics.
Experience in dashboard creation and, potentially, in the use of communication tools
Detail-oriented with the ability to maintain a high-level perspective
Strong organizational, planning and coordination skills, with the ability to prioritize tasks, manage multiple responsibilities, and proactively adapt in an evolving environment
Ability to interact and collaborate with cross-functional teams and various stakeholders
Analytical mind, ability to make improvement suggestions and resolving issues
Project management and influencing skills
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. You’re interested in this job? We kindly invite you to apply.
Our partner is currently looking for a Process Tech Transfer Engineer. Our partner is an international pharmaceutical company.
What are your responsibilities? Process Tech Transfer for mammalian biotechnological manufacturing processes:
Support process technology transfers between commercial plants, and support process validations in new plants.
Support process technology transfers from Development to Internal Manufacturing & CMOs and support commercial-scale process validation.
Support the technology transfer activities in terms of:
Definition of the Tech Transfer and process control strategy in collaboration with sending unit,Quality Assurance, Industrial Leads and other identified stakeholders,
Writing risk assessments, protocols, change controls, Tech Transfer reports, as well as technical reports for the execution of Tech Transfer runs for new processes,
Coordination of sampling and analyses with the manufacturing teams, as well as external laboratories, sending unit and Analytical Transfer & QC Readiness team.
Ensuring adherence to project planning.
Support the MSAT Bio Process Heads for tasks such as:
Review of documentation in Source CD,
Preparation and carry-out of Health Authority (HA) inspections.
Validation & Continued Process Verification (CPV) of mammalian biotechnological manufacturing processes :
Support process validation activities, including the definition of the validation strategy:
Drive and write risk assessments and change controls for current and new processes as a manufacturing process expert,
Write validation plans, protocols and reports in adherence with planning,
Ensure adherence of the process validation activities to the applicable documents (VMP, procedures, guidelines, etc.).
Support and ensure the implementation of CPV for new processes
Definition of the initial CPV plan, creation of the initial CPV report,
Creation of the routine CPV plan and participation to the routine CPV committees as SME for
the CPV requirements and methodology,
Implementation of process data trending,
Handover to the manufacturing teams,
Lead complex CPV investigations.
Support and coordinate the CPV activities for UCB on behalf of CMOs/partners.
Operational Support for mammalian biotechnological manufacturing processes:
Provide routine support for manufacturing campaigns, CPV, process and equipment performance trending, new equipment or raw material qualification, first-line troubleshooting and second-line troubleshooting for CMOs.
Support periodic reviews and Health Authority (HA) inspections,
Support filings of Prior Approval Supplement (PAS) submissions.
Process improvement & COGS reduction for mammalian biotechnological manufacturing processes:
Participate in the continuous improvement of Tech Transfer, process validation & CPV documentation and processes, including writing and coordination of Change Controls.
Monitor commercial manufacturing and identify improvement opportunities within the limits of the approved parameters.
Coordinate testing at small scale, validate, and implement process improvements within the limits of approved parameters, including review of protocols and reports for small-scale studies.
Liaise with development teams to provide feedback on platform process performance and/or request 2nd gen. process development.
Participate to deviations and Change Controls as SME for Tech Transfer/validation/CPV-related subjects and provide process expertise where needed.
Participate as SME in technical or organizational cross-functional projects, as well as in specific manufacturing projects for activities related to process Tech Transfer, validation and CPV.
Collaborate with the MSAT Lab team during complex process-related deviations and investigations.
Collaborate with the MSAT Process Leads during projects.
Support improvement projects within the group.
Quality:
Work according to cGMP requirements.
Perform all trainings in the defined deadlines, in order to ensure continued and complete state of training for Tech Transfer/validation/CPV activities.
Use and ensure the use of authorized documents for all activities.
Ensure that all validation/CPV/verification documentation (reports, sops…) is up-to-date and inspection ready.
Present the validation/CPV/verification documentation during inspections and audits by partners and Health Authorities (HA).
HSE:
Actively take part in the application of the HSE policy (Health, Safety and Environment): respect of HSE rules (procedures, wear of Individual Protection Equipment, systematic use of safety elements).
Signal events (incidents and accidents) linked to HSE,
Promote HSE processes within the team and to colleagues from other groups.
To contribute significantly to the construction of a responsible business approach that takes sustainability into
account at all levels (environmental/economic/societal), I am committed to integrating UCB's ambitions for:
Diversity, equity and inclusion,
Business health management (physical, social and mental health),
Environmental policy,
Ethics and Compliance,
Patient Value Added Culture (PVS),
Expected Behavior of Leaders.
Who are you?
Master’s degree in biology, biotechnology or other lifesciences-related field
Strong leadership skills,
High level of spoken and written French and English,
High understanding of biotechnological manufacturing processes,
Good level of proficiency with MSOffice tools,
Basic knowledge of statistics,
Excellent communication skills, for communicating with internal and external partners,
Ability to scope, research and understand complex subjects related to biotech manufacturing,
Ability to structure ideas quickly and clearly,
Excellent organization and problem-solving skills,
Ability to define objectives and how to reach them,
High capacity to anticipate issues, identify priorities and make decisions,
High level of autonomy and good stress management skills,
Solution-oriented and sensitive to customer needs,
Pragmatic and critical-minded,
Sense of responsibility and ownership,
Sense of initiative,
Team player.
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.
Pour notre client spécialisé dans le secteur du traitement de l'eau, nous sommes activement à la recherche d'un Senior Project Manager – Engineering.
Si vous êtes passionné·e par la gestion de projets complexes et que vous aimez travailler en équipe tout en ayant une vision stratégique, ce poste est fait pour vous !
Quelles sont vos responsabilitiés ?
Gestion et exécution des projets, de l’étude à la réception des travaux
Gestion contractuelle des clients, sous-traitants et fournisseurs
Elaboration et suivi des plannings d’exécution des travaux
Participation aux réunions de chantier et réunions clients
Suivi financier et gestion des budgets des projets
Coordination des équipes de terrain et gestion des équipes d’adjoints opérationnels
Développement des dossiers techniques et sélection du matériel nécessaire pour assurer le carnet de commande, supervision des dossiers d’offres technico-commerciales
Qui êtes-vous ?
Vous êtes titulaire d’un master d’Ingénieur civil ou industriel, avec une orientation mécanique et/ou génie civil.
Vous avez au minimum 10 ans d’expérience en gestion de projets d’installation
Vous êtes un·e « people manager » avec une forte capacité à encadrer et motiver vos équipes
Vous avez une fibre commerciale et un sens aigu de l’organisation
Vous aimez travailler en équipe et savez-vous adapter dans des situations stressantes
Vous êtes capable de trouver des solutions créatives aux problématiques de vos clients
Quelques exemples de projets d’envergure sur lesquels vous pourriez travailler : – Remplacement des groupes hydrauliques pour des treuils de levage – Remplacement de vérins de portes clapets – Station de pompage Hensies par vis d'Archimède – Entretien mécanique de barrages/écluses
Que pouvez-vous espérer ?
Jefferson Wells vous propose un contrat à durée indéterminée en tant que consultant, avec un package salarial attractif, ainsi qu’un accès à des formations techniques et en soft skills. Nous serons votre partenaire de carrière à chaque étape de votre parcours.
Ce poste vous intéresse ? N’hésitez pas à postuler !
Our partner is currently looking for a CMC Product Portfolio Manager. Our partner is an international pharmaceutical company.
What are your responsibilities?
Provide support and coaching to project managers for creating a master plan for their assigned project that includes timelines, required resources, the order of needed tasks, and the responsibilities of each project team member; the record and tracking of this information in the software applications
Work closely with the project managers to ensure that project milestones are met efficiently and within prescribed budget & resource constraints. Generate monthly reports on schedule adherence.
Consolidate all relevant CMC projects into a Portfolio per compound, ensuring appropriate links between projects, milestones and resources. Develop dashboard and KPI’s to drive efficiently the product portfolio inside the TST.
Identify any resource constraints proactively and drive the prioritization-making process in Patient Supply and CMC: prepare (and present) prioritization proposals to the Patient Supply LT or Asset LT for endorsement after TST agreement/discussion.
Coordinate budgeting effort to align Units, Operations, Functions and Practices to achieve consolidated product projects, budgets and monitoring.
Drive the increase of maturity on project management skills inside TST’s and identify areas of improvement for the CMC community.
Coordinate activities and knowledge gathering to ensure issues are addressed and escalated timely across the product portfolio stakeholders, with assertiveness and deep understanding of SME’s constraints on project/portfolio.
Who are you?
Minimum 5 years of project, program and/or portfolio management experience and in associated tools
Experience in enterprise planning/resource capability and systems. Knowledge of Planisware PPM tool is a strong asset
Solid understanding of the end-to-end CMC/Development (and associated disciplines) is a strong asset.
Languages: English is a strong asset and good basis (spoken and written) in French
Ability to work in cross-functional teams, including remotely
You are structured, with excellent organization skills
Robust knowledge of change management
A certification in PMP, PRINCE2, Agile, Lean or equivalent is a plus
Good communicator and listener in an international environment, you like to communicate complex data in a simple consolidated way
You are agile to gain commitment, proactive, accountable, quality-focused, resilient, with a positive mindset
Knowledge of the pharmaceutical environment; launch and life cycle management processes and the regulations applicable during development is an asset.
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.
Job Description: Operational: 1. Develop and validate analytical methods to support projects in development in different phases of product development. 2. 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, …). 3. 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, …) 4. Analyze results with readiness to criticize and ensures the consistency of these results with earlier data if relevant. 5. Participate to analytical exercise transfer to QC and subcontractors. 6. Monitor the documentation associated with the analytical laboratory activities by mastering the computer softwares in use at the laboratory (eg GLIMS, e-noval, Veeva, …). Quality: 1. Make sure to have received and understood all the information and instructions required for the tasks before starting work. 2. Respects the procedures and reports any discrepancies to the responsible 3. Use authorized and validated methods prior to testing, if applicable. 4. Respect and properly maintain the analytical equipment and facilities at disposal. 5. Performs double check the team. In short, you will develop and validate analytical methods for quality control of medication. You will also participate in the release and stability analyses of raw materials, intermediates, drug substances or drug products. Needs to be able to work in team, under the supervision of a scientist. Specific professional/technical expertise and key skills required:
Bachelor’s degree
Key technical backgrounds: small molecule chromatography (HPLC/UHPLC/GC) and detection techniques (UV/Vis, ELSD, RI, MS), USP/EP Pharmacopoeias
Experience in peptides analysis and basic mass spectrometry is a plus
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 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. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Your responsibilities: Our client is looking for a Procurement Specialist, responsible for procurement operations at a biological production facility for raw materials. This role is crucial in ensuring a smooth supply chain transition from project phase to commercial production.
Manage procurement operations, ensuring timely ordering and delivery of materials.
Process purchase orders and monitor stock levels using SAP (MM module, client-side transactions).
Communicate with planning teams and suppliers to guarantee smooth supply chain operations.
Handle supplier negotiations related to delivery schedules and urgent needs.
Address quality investigations in coordination with suppliers and internal teams.
Serve as the main point of contact for operational procurement issues.
Ensure compliance with procurement processes and guidelines.
Your profile:
Bachelor’s degree in Sciences
Experience in procurement, supply chain management, or related fields.
Strong knowledge of SAP MM module (client-side transactions, order processing, stock management).
Excellent organizational and problem-solving skills.
Ability to work autonomously while being a strong team player.
Fluent in English and in French.
Strong communication skills to interact effectively with suppliers and internal stakeholders.
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. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Your responsibilities: Our client is looking for a Documentation & Training Coordinator for a major project aimed at modernizing the artwork management system. This role is crucial to ensure the update and finalization of associated documentation, as well as the coordination of training for users. The person hired will work closely with a dynamic project team.
Coordinate the update of documentation according to the new defined structure.
Support Subject Matter Experts (SMEs) to ensure the timely delivery of documents.
Monitor and manage the documentation schedule.
Plan and organize the user training program (300+ people).
Ensure adherence to the schedule and follow up with stakeholders in case of delays.
Coordinate the transition period between the old and new systems.
Ensure smooth communication with the various teams involved.
Your profile:
Bachelor's Degree in Sciences
Fluency in French and English, Dutch is a plus.
Experience in documentation coordination for large projects.
Excellent organizational skills and strong responsiveness.
Diplomacy and ability to bring stakeholders together.
Advanced proficiency in Excel and project management tools.
Project management experience (without being a Project Manager) is a plus.
Experience in the pharmaceutical or regulated industry is a plus but not required.
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. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Understanding the specific needs of over 35 countries we operate in, balancing between standardization and local adaptation.
Translating these market requirements into clear supply chain processes.
Managing projects, coordinating with internal teams and external stakeholders.
Managing distribution processes, designing solutions that meet business and IT needs.
Ensuring smooth communication between business teams and IT departments, especially for market-specific solutions.
Leading Request for Proposals (RFP) processes with external partners and writing user stories when necessary.
Your profile:
Master’s degree in Sciences
Minimum of 5 years of experience in Supply Chain, ideally with expertise in distribution networks, supply chain management, and customer service management.
Fluent in English and French
Experience in Supply Chain Planning or Logistics role within pharma or food industry.
Good understanding of lean principles and methodologies.
Project management skills.
Ideally, experience in the pharmaceutical or a similar regulated industry, but experience in other industries (e.g. cosmetics, FMCG) could be considered.
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. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
