Emploi Location : BRAINE-L'ALLEUD

• Lieu: Braine-l'Alleud
• Travail #25193

Global Quality Auditing Outsourcing R&D Lead

‘Global Quality Auditing Outsourcing R&D Lead’ implements a Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) audit strategy, including delivery of a risk-based audit program covering the quality and compliance of the GCP/GLP Quality Systems. The incumbent is by this means ensuring that clinical trials are managed in compliance with regulatory requirements, contractual agreements, as well as company’s Global Quality Management System; and that compliance risks are appropriately identified and mitigated.

The Responsibilities

• 1. External Auditing vendor management

• Support vendor management involved in R&D audit activities and ensure compliance with regulatory requirements.
• Play a key role to assist in defining, evaluating, and monitoring key performance indicators (KPis) and drive key quality indicators (KQis) for R&D auditing vendors, and assisting with continuous improvement initiatives relating to management of vendors.
• Review and/or approve required Auditing Documents related to the activities in scope.
• Prepare, support and follow-up on R&D (GCP and/or GLP) audits performed on behalf of the company by external vendors, as per established process, contracts, and procedures. Ensure that execution of outsourced audits is conducted and completed in alignment with internal audit processes and standards. This also includes the appropriate oversight of vendors performing audits on behalf of the company.
• As required, provide management with a summary and analysis of quality risks and outcomes related to Auditing vendors activities.

• 2. External Auditing:

• Contribute and/or participate in the development of the risk based GLP/GCP audit program through evaluation of elements of the internal quality system and their effect on the overall state of compliance of the system.
• Perform GCP and/or GLP audits as per annual audit program (investigator sites, vendors, systems, … according to established audit strategy).
• Perform GCP and/or GLP audits of potential new vendors/partners for purposes of qualification prior to contractual relationships.
• Proactively manage findings, responses and CAPAs arising from audits in the Audit Management Tool, using all reasonable efforts to obtain prompt mitigation of deficiencies by responsible functions/persons and escalating concerns as required to senior management.
• Support the preparation, hosting and follow up of critical Regulatory Authority inspections related to clinical activities, in collaboration with the R&D and PV Quality team.

• 3. Drive Insights for UCB through Data:

• Ensure timely and accurate input of audit data in Audit Management Tool.
• Contribute data and feedback to GCP/GLP-relevant internal stakeholders in UCB (e.g. Global Clinical Science and Operations, Global Clinical Development, Development Rare Disease, etc.) relating to Key Quality/Performance Indicators and quality compliance status.

• 4. Compliance Issues:

• Through active participation to several forums and through direct interaction with colleagues, escalate concerns and provide expert guidance on GCP/GLP compliance issues to support the development and implementation of necessary CAPAS and quality improvement measures.
• Escalate Critical Compliance risks/issues to Global Quality Auditing Leadership.

• 5. Consulting, Educating, Quality Improvement, and External Focus:

• Utilize in-depth knowledge and understanding of current business trends, applicable regulations, and quality principles, to collaborate effectively and influence approaches to quality, and ensure work products and output are aligned with regulatory guidelines, ICH/GCP, GLP regulations, other applicable regulatory requirements, and the company global quality standards.
• Participate in medium-long term projects within competence.
• Upon the request of/with the approval of Global Quality Auditing Leadership, perform other tasks within competence (as determined by relevant training, experience and/or qualifications).

The Skills and Knowledge Requirements

• Substantial and broad-ranging experience in the pharmaceutical/biotechnology area including significant time working in GCP/GLP related areas.
• 3 years’ experience in leading full range of GCP audits for internal processes/units and external partners or vendors, with depth of understanding of the theory and practice of quality management.
• Experience in the pharmaceutical/biotechnology area including time working in GLP and/or GCLP-related areas.
• Minimum of 3 years of auditing and 5 years overall dealing with research and development area. Experience in vendor management is a plus.
• In-depth knowledge and understanding of ICH-GCP, applicable regulations (domestic and international), quality principles, relevant business processes and techniques. Able to apply theoretical knowledge in practical situations.
• knowledge and understanding of Human Tissue Act and the Human Tissue Authority (HTA) codes of practice, GLP, GCLP, Good Research Practices and their applicable regulations (domestic and international), quality principles, relevant business processes and techniques.
• Fosters a quality culture of shared accountability and knowledge sharing through inspiring, motivating, influencing, teaching and coaching others.
• Knowledge regarding the use of electronic systems in a regulated environment, and personal functional computer literacy
• High level of personal integrity with a strong commitment to patient welfare and ethical behavior.
• Fluent in written and spoken English. Additional language skills would be an advantage.
• Able to travel nationally and internationally as business necessitates,20% of time on average.
• Demonstrated self-starter, highly reliable, with positive, action oriented, enthusiastic approach, ability to manage own workload, set priorities within the remit allocated by management and willingness to accept responsibility.
• Confident presenter and communicator, able to give presentations to interdepartmental audiences and represent company with externals and deliver clear verbal and written messages in a constructive and effective manner to a variety of audiences/recipients.
• Skilled negotiator, able to influence and obtain cooperation from colleagues, business partners and other stakeholders, including senior management during audit process.

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. If you are interested, you can send your CV to [email protected] .

 

• Lieu: Braine-l'Alleud
• Travail #25179

Engineering Lead Coordinator

Contracting – Braine l’Alleud

The Responsibilities

• To evaluate the feasibility and risk associated with Capital Investment (CAPEX) projects.
• To relay customer consideration and take benefit of his expertise in the definition of requirement (URS) and the solution design.
• To ensure the management of the supplier until the FAT, SAT and commissioning.
• To support the qualification according to company SOPs and ICH guidance.
• When applicable to organize the process technical transfer.
• This includes:

• To elaborate the technical transfer strategy and to prepare/review of the test protocols. The input should be based on the coordinator’s technical background and the knowledge of the equipment to define a plan technically feasible and acceptable on GMP aspect.
• To coordinate support departments (RA, QC, QA, Qualification/Validation, Development, Technical Services, Industrial IT, Supply Chain, HSE, Metrology, Sourcing, Facility, Finance, Utilities…) for projects implementation.
• To prepare the equipment and to program the recipes on manufacturing equipment.
• To ensure that the equipment runs properly and if needed to connect with supporting services (maintenance, IT and external supplier/service providers).

• To deliver to the client the technological know-how capitalized during commissioning and qualification campaign.
• To support the client department for pre-approval inspections of delivered new equipment and processes.
• To identify, propose and implement technical solutions to improve plant capacities, to reduce COGS, to increase efficiency and improve Quality compliance.
• To supervise the strict application of Safety & Hygiene rules and foster development of improved practices.

Skills and Knowledge Requirements

• Knowhow in automation, packaging, and medical devices technologies
• Senior experience on Project management methodology.
• Prioritization skills and ability to successfully manage multiple tasks simultaneously.
• Teamwork: ability to work well in highly cross functional and inter-site team environment.
• Communication skills: ability to express clearly and concisely within a team. To adjust communication style for the audience. To timely and effectively communicate on issues.
• Technical writing skills to support authorship of internal documentation.
• Knowledge sharing: ability to capture and to digest information from multiple sources and to build intelligible knowledge to be shared with project clients.
• Knowledge of GMPs

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. Do you have any questions? You can contact Aylin Ugurlu at [email protected]

• Lieu: Braine-l'Alleud
• Travail #25162

Non-Clinical formulation Scientist
Contracting – Braine l’Alleud

The Responsibilities

• Manages Non-clinical formulation activities related to the screening and CMC development of small molecule, peptide or other synthetic drug products (from discovery and preclinical stages to clinical formulation orientation work for First-In-Human). Typical formulations are microsuspensions, amorphous solid dispersions, and nanosuspensions.
• Liaises with Non-Clinical formulation Leads to assure consistency between the development and the production of NCL formulation, and the project needs.
• Manages protocols of development or production and participate to the planning of activities.
• Participates to the development, characterization, and production of non-clinical formulations.
• Performs the physico-chemical characterization and stability studies of new molecules (NCEs) on batches before the GLP batch. Typical characterization techniques are liquid chromatography (UPLC), thermal analysis (DSC, TGA), laser diffraction granulometry, optical and electron microscopy. Develops if needed new methods.
• Analyses results with readiness to criticize and ensures the consistency of these results with earlier data if relevant.
• Documents and verifies in an appropriate manner the whole of the performed activities (e.g. Electronical Lab Notebook)
• Consolidates the results and write adequate reports.
• Contributes to the writing of technical documents like SOPs, user guides, guidances, etc.
• Participates to the advancement of the department’s Science & Technology and Innovation projects The scientist needs to be autonomous and think pro-actively, in collaboration with the Non-Clinical formulation lead. The need to already have an experience in formulation with a preference for Non-Clinical formulation development, with knowledge in the related analytical support. He needs to be flexible, well-organized, curious and have good communication and coaching skills. He needs to be able to combine multiple tasks and must adapt to priority changes.

Skills and Knowledge Requirements

• Master/PhD: pharmaceutical sciences, formulation, analytical chemistry or equivalent
• Min years’ experience required: 2-3 years in formulation domain, preferentially in non-clinical formulation field.
• Key technical backgrounds: non-clinical formulation preparation, small molecule chromatography (HPLC/UHPLC)
• Mandatory skills: team player, communicative, experience in a similar position/environment, compliant/rigorous, flexible, curious

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.
 

• Lieu: Braine-l'Alleud
• Travail #25146

Analytical Development Analyst
Contracting – Walloon Brabant

Your responsibilities ?
Operational :

• 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 pakaged 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

Your profile ?

• 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 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. Do you have any questions? You can contact Caroline, [email protected]

 

• Lieu: Braine-l'Alleud
• Travail #25145

Laboratory Scientist Non-Clinical formulation

Contracting – Braine l’Alleud

The Responsibilities

• Participates to the development, characterization, and production of non-clinical formulations (micro or nano suspension, amorphous solid dispersion by spray drying…)
• Performs the physico-chemical characterization and stability studies of new molecules (NCEs) on batches before the GLP batch.
• Develops and use analytical and physico-chemical methods (UPLC, Microscopy, particle size, DSC, TGA…)
• Analyses results with readiness to criticize and ensures the consistency of these results with earlier data if relevant.
• Documents and verifies in an appropriate manner the whole of the performed activities (e.g. Electronical Lab Notebook)
• Communicates appropriately the results and any event that might have a potential impact on the quality or timelines of the activity, to the supervisor or other concerned people.
• Contributes to the writing of technical documents like reports, SOPs, user guides, guidances, etc.
• Assures logistics and stock management of products, small equipment, protective equipment (PPEs), consumables.
• On equipment, performs calibrations and other necessary verifications in agreement with procedures and reference documents and assures the integrity and the maintaining of proper functioning of the instruments.

The Skills and Knowledge Requirements

• Master/Bachelor/graduate: analytical chemistry, formulation, chemistry or equivalent
• Min years’ experience required: 2-3 years in analytical domain.
• Key technical backgrounds: small molecule chromatography (HPLC/UHPLC), DSC, TGA, microscopy (optical, SEM), non-clinical formulation preparation.

• Mandatory skills: team player, experience in a similar position/environment, compliant/rigorous (understands the importance of following procedures in detail).
• Language skills:
  • English: able to read/write scientific documents.
  • 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.
 

• Lieu: Braine-l'Alleud
• Travail #25141

Clinical Supply Performance and System Expert
Contracting – Walloon Brabant
As a clinical supply Performance and System Expert, you will work on supply chain analytics and digitalization topics. You will play a crucial role in bridging the gap between clinical supply chain needs and the latest technologies.
You will capture assumptions, model the clinical trials and seek the optimal risk/cost supply strategies, as well as perform tactical what-if scenarios.
You will work with several advanced tools and be a central stakeholder to scale up or deploy existing/new tools.
As part of the Performance & System team, you might also be involved in (digital) continuous improvement projects, provide trainings to stakeholders on an ad-hoc basis.
Your responsibilities ?
Supply chain analytics :

• Understand and capture supply chain and clinical challenges
• Serve as a central stakeholder in the deployment and scaling up of supply chain tools
• Master dedicated clinical supply chain tools
• Propose and justify optimal supply solutions (risk v. cost trade-off)
• Provide guidance on What-ifs scenarios or IRT settings
• Maintain and update technical knowledge of Clinical Supply Chain

Digitalization and system enhancement :

• Identify and propose system enhancements
• Contribute to systems roadmaps according to business needs
• Contribute to digital transformation journey
• Develop and monitor dashboards

Communication :

• Act as a digital advocate: understand, inform, assist, challenge and train users
• Inform stakeholders on projects/initiatives updates (Project management)

In addition to these core services :

• Lead and participate in continuous improvement projects, mainly related to reporting and digitalization
• Ability to travel domestically or internationally for business reasons on an as needed basis.

Your profile ?

• Good knowledge of Supply chain concepts
• Strong analytical and problem-solving skills
•  Good critical thinking and holistic mindset
•  IT literacy and curiosity
• Team spirit and collaborative mindset
•  Good communication & Presentation skills (English fluency)
• Ability to challenge status-quo and to propose solutions

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. Do you have any questions? You can contact Caroline, [email protected]

 

• Lieu: Braine-l'Alleud
• Travail #25118

Material Documentation Specialist

Ce poste fait partie de l'équipe Supply et logistique. Les membres de l’équipe Supply assurent l’approvisionnement en matières et matériel afin d'assurer les activités GMP et non-GMP. La principale responsabilité sera la gestion des Specification et des Change Notification pour les produits biologiques et les thérapies géniques.

Responsabilités

• Assurer la création et la mise à jour des spécifications / FIP et des documents associés (TSE/BSE, Certificats…) pour les matériaux et consommables utilisés en collaboration avec les laboratoires et les ingénieurs process.
• Évaluer/documenter les Change Notification de la Pharmacopée ayant un impact potentiel sur les produits utilisés et mettre en œuvre des actions si nécessaire.
• Gérer l’évaluation des notifications de changements des fournisseurs pour les matières premières et définir des actions associées.
• Participer activement au système de gestion des déviations (ouverture de PR, investigations, CAPA, Change control…) et s’assurer de leur réalisation en temps et en heure
• Gestion logistique des vêtements nécessaire au bon déroulement des activités GMP et le suivi du fournisseur associé
• Participer aux activités de sécurité

Connaissances et Expériences Requises

• Esprit organisé et systématique
• Excellentes compétences en communication, dans la mesure où vous interagissez avec différentes équipes/parties prenantes : opérateurs, responsables de la production, équipe de validation, QA.
• Esprit d'amélioration continue.
• Maîtrise du français et bonne connaissance de l'anglais

Notre Offre
Si vous êtes passionné(e) par l'innovation et que vous souhaitez contribuer à un projet stimulant au sein d'une entreprise de renommée mondiale, postulez dès aujourd'hui à notre offre. Jefferson Wells s’engage à vous offrir un contrat en consultance, un accompagnement rapproché ainsi qu’un salaire et un package attractifs. Des questions ? Vous souhaitez soumettre votre candidature ? Envoyez un mail à [email protected] .
 

• Lieu: Braine-l'Alleud
• Travail #25084

Raw material scientist
Role Summary
The Raw Material Scientist is a technical expert responsible for establishing and coordinating a comprehensive strategy to identify critical/key raw materials during development to support process development decision making.
They will support the definition of appropriate technical controls and the implementation these practices during the development of biologics and gene therapy products to improve process robustness, cost efficiency, and readiness for regulatory submissions.
Key Accountabilities

• Generate risk assessments strategy for current raw materials and identify critical and key ones from a process and supply point of view.
• Support the QbD initiative on raw material and GRAM exercise (CMA KMA definition, generate guideline 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 design supportive studies required.
• 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.

Critical Competencies & Experiences Required

• At the very least 2 years of experience in CMC development within the biopharmaceutical industry.
• Demonstrated ability to successfully co-ordinate project activities and manage meetings.
• 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.
• Ability to learn proactively.

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]

 

• Lieu: Braine-l'Alleud
• Travail #24921

Data Integrity and Quality Culture Specialist
Contracting – Walloon Brabant
Your responsibilities?
As Data Integrity and Quality Culture Specialist, you will be our local expert for Data Integrity and Quality Culture. 
You will

• Lead the implementation of the data integrity culture and strategy for our site and ensure compliance with global and local regulatory requirements and customer expectations at the system level
• Ensure that best practices are in place and in use, seek for continuous improvement, while ensuring application of the right level (risk-based approach) of quality
• Assure capabilities buildup within the site through effective coaching, monitoring/reporting, and performance management.

Your Major accountabilities will be:

• Definition and follow-up of data integrity & Quality Culture roadmap for the company. To evaluate and lead continuous improvement initiatives (i.e. Site Quality Plan) concerning data integrity & quality culture, to ensure compliance with quality systems, global requirements, regulations, guidelines and customer requirements.
• Developing and maintaining the Quality Management System in relation to data integrity & quality culture: evaluate the performance management of data integrity, make results visible through KPIs and periodic reports.
• To manage the creation, review, maintenance and delivery of Data Integrity & Quality Culture training material, including but not limited to data integrity onboarding, refresh trainings and excel spreadsheet validation trainings. Train and mentor on the job personnel on data integrity & quality culture aspects from onboarding to increased maturity.
• Participate as data integrity & quality culture Subject Matter Expert in deviation investigations applying RCA tools. Propose and implement associated CAPA / improvement actions concerning data integrity & quality culture. Train and coach deviation investigators on the use of Data Integrity RCA tools and investigating human errors.
• To review and maintain documents related to quality culture and data integrity in accordance with current quality system requirements, regulations, guidelines, and customer expectations.
• Establishment and leading an internal site network of DI champions and actively participating in creation of global multi-site DI community of practice within the company group. Be the point of contact for the site within group.
• To perform Data Integrity internal audits and act as an SME during internal and external audits and inspection for Data Integrity & Quality Culture topics, redacting responses and managing the associated follow-up actions.

Your profile?

• Bachelor or Master’s Degree in Biology, Biomedical Sciences, Pharmacist, Bioenginneer or similar
• Proven experience (at least 3 years)in Quality Assurance or related areas in a GMP environment, including a position of authority in decision making and management of documentation and / or IT.
• Experience in leading training programs and projects in a GMP environment is preferred
• Basic knowledge in multiple quality processes and interfaces with multiple functional areas
• Knowledge of Good Manufacturing Practices standards, local and international regulatory requirements with regards to data integrity & quality culture
• Knowledge of Documentation and Electronic Systems that generate and manage GxP processes and Computer System Validation
• Excellent team spirit and communication skills
• Very good knowledge of French AND English (written and spoken)

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.