• 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 #26188

Process Tech Transfer Engineer

Brabant Walloon – Contracting

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.

• 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.