• Location: Braine l'Alleud
• Job #26479

Raw Material Scientist

Contracting – Brabant Wallon

Responsibilities:

• Generate risk assessments strategy for current raw materials and identify critical and key ones from a process, quality and supply point of view. Create and maintain related database and dashboard.
• Support the QbD initiative on raw material by writing supportive documentation (generate guidelines and templates) ▪ Define based on risk assessment mitigations and controls to be implemented in collaboration with appropriate teams (in production, release at supplier, shipment, storage, during usage).
• Support the introduction of new raw materials in close collaboration with process teams (supplier selection criteria at early stage, IPC/specifications definitions, shelf life definitions, ..)
• Improve raw materials usage in collaboration with process development and clinical manufacturing
• Create and lead satellite communities per expertise to facilitate exchanges, identify gaps and mitigations, build strategies on lessons learnt and successes to prepare future.
• Author & review technical documents including CMC regulatory sections, SOPs, technical position papers, & technical reports
• Accumulate knowledge based on lessons learnt, investigation and literature on potential risks, quality and regulatory requirements and suggest alternatives
• Collaborates with internal and external partners to stay abreast of industry trends and emerging risks related to raw materials, regulatory and quality requirements evolution, best practices.
• As a member of the DSPS team, the raw material scientist may work transversally across projects and groups in line with the needs of the business and as part of the CMC Development Sciences organization.

Must-Have Qualifications:

• > 4 years of experience in CMC development within the biopharmaceutical industry.
• Demonstrated ability to successfully co-ordinate project activities and manage meetings.
• Good knowledge of bioprocesses (Upstream/Downstream) with previous technical experience in Biologics or Gene therapy.
• Good interpersonal skills in order to communicate with and maintain fruitful working relationships with colleagues across departments and geographies, as well as external partners.
• Basic knowledge of regulatory guidelines, safety and quality requirements for raw materials

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?

• Location: Braine l'Alleud
• Job #26478

External Operations Quality Partner

Contracting – Brabant Wallon

Responsibilities:

Operational

• Provide timely and efficient GMP/GDP IMP Release function to all relevant company's project activities related to the development of the pipeline projects (included all relevant activities for IMP release: label approval, batch record documentation, etc…).
• Support compliance with all relevant and appropriate regulations and guidelines, such as those relating to GMP/GDP, health and safety, etc..
• Support the systems and processes in place for the appropriate documentation of company's development activities and to maintain them in a manner compliant with regulatory and corporate requirements.
• Ensure the Clinical Supply Quality activities are consistent across the range of different environments and teams supported (Vendors / Suppliers / in house).
• Proactively support the activities of Clinical supply for relevant manufacturing quality systems (deviation close out / Change management / complaints / quality improvement).
• Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions.
• Provide support in the evaluation of Temperature excursions for IMP.
• Management of Quality Complaints of IMP.
• Ensure active participation in the selection, evaluation, approval and maintenance of Vendors for IMP activities, including leadership or support to conduct appropriate audits.
• Oversight of Distribution activities (deviations, Business Review Meetings, assessments, etc…)
• Ensure CMO (packaging and distribution vendors) quality documentation is accurate and up-to-date, by editing and reviewing quality agreements
• Contribute the preparation of audits (internal/external, regulatory inspections)
• Lead internal audits / Self-Inspections

Process

• Ensure that all review and release, manufacturing and packaging operations are appropriately compliant with applicable regulations (EMEA, FDA, DEA, MHRA, etc. where relevant). Support the Head of Clinical Supply Quality in ensuring an acceptable outcome of all audits and inspections, especially those by government agencies, as they pertain to Process Support and Package Development practices (where relevant), equipment, and facilities.
• Actively participate in identifying, developing and implementing local quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirements by encouraging others to seek opportunities for different and innovative approaches to addressing problems and developing solutions.
• Ensure Clinical supply Quality processes directly support Technical Operations and development partner goals and objectives.
• Review and QA approval of deviations, change controls and complaints.

Must-Have Qualifications:

• Master's degree in analytical chemistry.
• Good knowledge of cGMP and relevant regulatory requirements (e.g US, European, Japanese)
• QA/compliance experience in pharmaceutical regulated environment
• Function effectively with minimal supervision
• Good teamwork and project management skills. Must have strong, organization and analytical skills.
• Must be fluent in English, other languages are a bonus
• Facilitator, influencer and planner
• Fact based decision maker: understand complex issues and have the ability to contribute to informed decision making when working on “grey” issues
• Able to make/influence quality/compliance decisions in a CMC development environment.

Problem solving (Describe the level of “self-starting” thinking required in the for recognizing, analyzing and solving problems)

• Experience of participation in failure investigations
• Familiarity with risk analysis techniques

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?
 

• Location: Braine-l'Alleud
• Job #26442

External Operations Quality Partner 
Brabant Wallon – Contracting 
What are your responsibilities?

• Batch record review and administrative support (e.g., updating CoC, handling deviations, complaints, temperature excursions).

• Provide timely and efficient GMP/GDP IMP Release function to all relevant internal project activities related to the development of the pipeline projects

• Support compliance with all relevant and appropriate regulations and guidelines, such as those relating to GMP/GDP, health and safety, etc..

• Support the systems and processes in place for the appropriate documentation of internal development activities and to maintain them in a manner compliant with regulatory and corporate requirements.

• Ensure the Clinical Supply Quality activities are consistent across the range of different environments and teams supported (Vendors / Suppliers / in house).

• Proactively support the activities of Clinical supply for relevant manufacturing quality systems (deviation close out / Change management / complaints / quality improvement).

• Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions.

• Provide support in the evaluation of Temperature excursions for IMP.

• Management of Quality Complaints of IMP.

• Ensure active participation in the selection, evaluation, approval and maintenance of Vendors for IMP activities, including leadership or support to conduct appropriate audits.

• Oversight of Distribution activities (deviations, Business Review Meetings, assessments, etc…)

• Ensure CMO (packaging and distribution vendors) quality documentation is accurate and up-to-date, by editing and reviewing quality agreements

• Contribute the preparation of audits (internal/external, regulatory inspections)

• Lead internal audits / Self-Inspections

Who are you?

• 5 years’ experience in QA/compliance experience in pharmaceutical regulated environment

• Good knowledge of cGMP and relevant regulatory requirements (e.g US, European, Japanese)

• Strong experience in batch review.

• Quality mindset with a pragmatic and proactive approach.

• Fluent in English is a must and French is a nice to have.

• Experience working with CMOs and vendors.

• Familiarity with GMP and GDP standards.

• Experience with quality systems (deviation management, complaints, change control)

• Familiarity with clinical packaging environments (vs. commercial) is a plus

• Certified auditor status is a plus.

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 invite you to apply! 

• Location: Braine l'Alleud
• Job #26406

Analytical Development Analyst

Contracting – Brabant Wallon

Responsibilities:

• Perform analyses on raw materials, intermediates, and finished products (stability, IPC, clinical release, investigations).
• Develop and validate analytical methods for different phases of product development.
• Ensure stability and clinical release testing for phases I and II.
• Participate in analytical method transfers to QC and subcontractors.
• Use lab software: Empower (Waters), GLIMS, e-noval, Veeva.
• Analyze results with a critical mindset, ensuring consistency with previous data.
• Follow procedures, use validated methods, and maintain analytical equipment.
• Work under the supervision of a project scientist, collaborating with – Chemical Process R&D and Drug Delivery Design teams.

Must-Have Qualifications:

• 3 to 5 years of experience in analytical chemistry (small molecules).
• Bachelor’s degree in analytical chemistry.
• Technical expertise: HPLC/UPLC, GC, detection via UV/Vis, RI, MS.
• Familiarity with USP/EP pharmacopoeias.
• Proficiency in Empower software (mandatory).
• Strong critical thinking, scientific curiosity, and ability to challenge results.
• Good understanding of technical written English.
• Experience in the pharmaceutical industry.
• Familiarity with other chromatography data systems.

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]
 

• Location: Braine l'Alleud
• Job #25911

Bioprocess System specialist
Contracting – Brabant Wallon
Your Responsibilities:

• Handle troubleshooting in production, particularly when issues arise with cleaning or production equipment.
• Participate in task force meetings to address and resolve production-related problems.
• Work on multiple projects simultaneously, with tasks changing depending on the project's phase.
• Review documentation during the early stages of projects, and visit production areas to monitor CIP (Cleaning in Place) sites to ensure all systems are functioning properly.
• Be adaptable, as each day varies greatly based on the needs of ongoing projects.

Your Profile:

• Experience: A minimum of 2 years of experience in a pharmaceutical company, specifically in cleaning process equipment. Experience in USP or DSP processes is a plus, as long as you have a basic understanding of pharmaceutical equipment cleaning requirements.
• Pharma Experience: Strong background in the pharmaceutical industry is a must, ideally with a focus on clinical operations. Candidates with cleaning experience are preferred. Pharmaceutical experience is critical as training on GMP zones, attire, and behavior can be time-consuming.
• Autonomy & Proactivity: You must be able to work independently without constant supervision. The team is looking for someone who is proactive and can handle challenges autonomously.
• Experience with managing deviations and investigations, handling change control, implementing CAPAs (Corrective and Preventive Actions), and developing cleaning strategies is highly valued.
• Languages: French proficiency is essential for daily communication, as most protocols and reports are in French. While basic English skills can be helpful, English is not required for the role.

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]

 

• Location: Braine l'Alleud
• Job #26219

Scientist, Injectable DP process development

Contracting – Brabant Wallon

Your responsibilities:

• 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]

 

• Location: Braine-l'Alleud
• Job #26213

Learning & Documentation Coordinator

Brabant Wallon – contracting 

What are your responsibilities?

• Documentation & Learning lifecycle management:

• 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

 

• Regulated, non-Regulated & Controlled Document management

• 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.

 

• Location: Braine-l'Alleud
• Job #25423

HSE Compliance Officer
We are looking for a motivated and experienced individual to join our team in the local support department in Belgium, within the Health, Safety, and Environment (HSE) service. Although the role touches on health and safety, it focuses primarily on environmental aspects. The position involves working on environmental projects and maintaining regulatory compliance across multiple regions (Wallonia, Brussels, Flanders).

The person will be responsible for managing environmental issues, including the “Licence to Operate” for our sites in HQ, Leuven, and Braine, in relation to environmental and urban planning permits. The individual will closely collaborate with the engineering team to ensure the necessary permits are obtained.

The Responsibilities

– Environmental Permits Management (Licence to Operate): Preparation, modeling, and data collection for the environmental and urban planning permits required for site activities
– Regulatory Compliance: Ensure compliance of installations with legal health, safety, and environmental requirements, especially regarding the risks associated with the storage of hazardous materials (CVZO).
– Environmental Projects: Track and manage environmental projects, including internal audits, measurement campaigns, and reporting to authorities.
– Environmental Management System: Maintain and improve our certified environmental management system. Participate in internal audits, measurement campaigns, and manage the administrative data related to environmental services.
– External Collaboration: Work with external consultants and experts to ensure effective environmental management and smooth communication with local authorities.

Skills and Knowledge Requirements

– Scientific Background: Degree in a scientific field with a specialization or relevant experience in environmental management.
– Environmental Management Experience: Experience in managing environmental issues, with good knowledge of local regulations (Wallonia, Brussels, Flanders).
– Administrative Knowledge: Ability to understand and follow environmental regulatory requirements and perform necessary reporting.
– Legislation Knowledge: Knowledge of environmental legislation in Belgium (Wallonia, Brussels, Flanders) is an asset.
– Languages: English is not required, but knowledge of Dutch is a plus, particularly for the Leuven site.
– ISO Certifications: Experience in an environment with a certified environmental management system (ISO 14001) is an asset but not a requirement.
– Flexible Working Hours: This position is a 50% replacement for the sick expert, with flexible hours (Tuesday, Wednesday, and Thursday mornings).
– Remote work is permitted when on-site presence is not required, but there are no fixed remote work days.
Additional Assets:
– Experience with Seveso risk management (hazardous materials storage).
– GMP (Good Manufacturing Practices) certification is a plus, but not required.
– Ability to ask questions and solve problems independently.

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]
 

• Location: Braine-l'Alleud
• Job #25387

QC Equipment Specialist
Join the QC team, working with a substantial analytical equipment park. The role goes beyond just qualification and maintenance of equipment, focusing primarily on the coordination of various activities related to these pieces of equipment. This role is akin to that of an architect, as it requires an overall view of the equipment's lifecycle.

The Responsibilities

• Equipment Management:
  • In the event of a breakdown, identify and coordinate necessary actions with internal and external stakeholders.
  • Follow-up on equipment, install new equipment, and manage related projects.
  • Coordinate with support departments to ensure proper maintenance, qualification, and installation of equipment.
  • Project Management: Track timelines, budgets, and required resources for installation or upgrades of equipment.

 

• Activity Coordination:
  • Serve as the point of contact for different stakeholders: qualification/validation, maintenance, IT, QA, laboratory (end users).
  • Perform testing, when necessary, in collaboration with the laboratory.
  • Ensure smooth execution of projects while adjusting priorities and juggling multiple tasks.

 

• Planning and Monitoring
  • Manage several simultaneous projects, with up to 4 to 5 pieces of equipment to manage per person.
  • Use the Integrate software to track various projects and activities.

Required Skills and Profile

• • Rigorous and Organized: The candidate must be highly structured and able to manage shifting priorities.
  • Multitasking: Ability to work on multiple projects at once, sometimes dealing with urgent changes in priorities.
  • Experience with Laboratory Equipment: Knowledge of analytical equipment in GMP (Good Manufacturing Practices), such as HPLC, UPLC, UV, Infrared, PCR vessels, fridges, and freezers.
  • Familiarity with LIMS, Source, and Integrate systems is a plus.
  • Communication Skills: Ability to understand and write documentation in English (B2 level minimum), as equipment documentation is mostly in English. Ability to communicate with external suppliers and manage international interactions.

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]

• Location: Braine-l'Alleud
• Job #25357

Research Scientist Regulatory Bioanalysis
Le consultant devra assurer la réalisation dans les meilleures conditions de qualité et de délai, le développement et la validation de processus bio-analytiques automatisés en environnement régulé GLP & GCP (BPL & BPC). Ces processus devront suivre et respecter les règles des Bonnes Pratiques de Laboratoire et les sections applicables des Bonnes Pratiques Cliniques.
Ces processus auront pour but la quantification des analytes présents dans les échantillons biologiques provenant d’études précliniques et cliniques.
La fonction s’appliquera aux points suivants :
À la sélection, à l’implémentation et à la validation (computerized system validation for GLP and GCP activities) d’applications et d’instruments utiles au laboratoire de bioanalyses.
Au développement de méthodes et de processus automatisés, utiles à la gestion et à la manipulation d’échantillons tests provenant de divers laboratoires, services ou départements, ou sous-traitants (études de pharmacocinétique, toxicologie, pharmacologie).

Les Responsabilités

• Assurer de la bonne gestion du matériel et des équipements de laboratoire (maintenance, calibration, qualification), en tant qu’utilisateur, responsable d’appareil ou suppléant.
• Développer des méthodes et des processus bio-analytiques automatisées.
• Être responsable de la validation des applications et des instruments du laboratoire.
• Réaliser les essais au laboratoire, et parfaire sa formation technique et scientifique.
• Prévoir les besoins en produits, réactifs et matériel de laboratoire nécessaires à la réalisation des objectifs qui lui sont confiés.
• Rédiger et revoir des procédures d’opération standards.
• Assurer la conformité aux normes GLP & GCP.
• Veiller au respect des procédures de travail et de sécurité.
• Suivre l’évolution des connaissances dans les domaines techniques et scientifiques qui relèvent de la spécialisation du laboratoire et des objectifs qui lui sont confiés.

Connaissances et Expériences requises

• Une connaissance pratique des normes GLP & GCP.
• Développement de méthodes et de processus.
• Rédaction et revue des procédures.

Notre Offre
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.