Experience Cyber security and IT compliance/validation
Experience project Management and compliance
Experience qualification / validation process
Experience Data integrity concept and quality system
International experience a plus
Key technical backgrounds: small molecule chromatography (HPLC/UHPLC/GC) and detection techniques (UV/Vis, MS), electrophorese, USP/EP Pharmacopoeias, RMN, …
Mandatory skills: team player, exp. in a similar position/environment, compliant/rigorous
Fluency in French and English
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: Part of the Development Quality Pharma Operational team, you will ensure the establishment, implementation, maintenance, and continuous improvement of an effective Quality Management System (QMS) linked to product development for:
The GMP oversight of different laboratories and production pilots, including packaging, and outsourcing
The GSP oversight (non- GMP activities) of different development entities, located on the Braine site (BE), the Slough site (UK) and the Monheim site (DE).
You will also:
Drive continuous quality improvement process, ensuring that the Quality Management System in support of product development and clinical supplies, work in a way that ensure product quality, safety and efficacy, meet regulatory requirements and expectations and operate in a fit for purpose and in a smarter way.
Provide support to build the end to end “issued copy process’ for DEV/DSC entities.
Act as Reconciler by checking the correct completion of the “issued Copy” process,
Coordinate the development local instructions, liaise with dev key stakeholders in order to maintain common practices with regards to “issued copy” within development entities” ensuring appropriate application of the “issue copy process.”
Provide support during regulatory inspections, and quality improvement initiatives. You will contribute the preparation of audits (internal/external, regulatory inspections )
Provide guidance and expert advice to development scientists, particularly with regard to the appropriate interpretation of national and international GMP regulations and guidelines
Identify, mitigate and subsequently resolve compliance and quality issues that may affect the company development activities and products. These lessons learned, once implemented, shall then form the basis for future cross functional and cross project training and improvement opportunities.
Support QA activities for all Dev QA entities ( Lab, pilot plant,…..)
Maintain and continuously improve Quality systems and processes in place for the appropriate documentation of the company development activities and ensure compliance with regulatory and corporate requirements.
Partner with QA and CMC Development/DCS colleagues to identify and mitigate Compliance risks, resolve potential regulatory observations.
Implement and maintain adequate Quality & Compliance Indicators and communicate results to appropriate levels of the organization
Manage Quality meetings to maintain adequate level of compliance of the business activities.
Ensure data integrity and compliance with regulatory requirements and industry best practices
Proactively support the activities of Development Quality Lead for relevant laboratory/manufacturing quality systems (deviation close out / change management/ complaints/ quality improvement).
Ensure Development Quality Management System directly support Technical Operations and development partner goals and objectives
Lead the GMP refresher project for CSC and Lab entities
Your profile:
Master’s or bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, or Quality Management).
Minimum of 3 years of experience in data integrity and documentation control within the biopharmaceutical industry.
A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
QA/compliance experience in DS/DP/IMP manufacturing, facility operation, laboratory compliance and quality systems is an asset.
Fluency in French and English
Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments
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: As a part of the Internal Bio & GT Manufacturing Systems Quality Team, you will:
Work closely with Clinical Manufacturing Teams to ensure that the Quality Management System in support of product development and clinical supplies, work in a way that ensure product quality, safety and efficacy, meet regulatory requirements and expectations and operate in a fit for purpose and in a smarter way.
More specifically, provide quality support for qualification and validation activities related to Clinical Manufacturing activities like facilities cleaning processes, viable and non-viable environmental monitoring, equipment and system qualification/validation
Drive the continuous QA improvement process. Ensure adequate documentation processes and systems are available and followed for development projects (SOPs / Protocols / Report review…)
Plan and manage compliance tours and on the floor spot-check of the GMP area, offering quality assurance support including but not limited to inspection.
Be partner with other departments to identify, mitigate and subsequently resolve compliance and quality issues (Investigations / deviations / out-of-specifications) that may affect the company development activities and products.
Support Change Control and perform the QA evaluation
Ensure KPI (including extracts) are adequately maintained and Shared.
Ensure Issued Copy document are following the issued copy and reconciliation process
Your profile:
Master’s degree in Sciences
Fluency in French and English
A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
QA/compliance experience in DS manufacturing, facility operation, laboratory compliance and quality systems are an asset.
Good background knowledge of the pharmaceutical biologics industry and applicable technical aspects of the Business
Understands practical applications of GMP, compliance principles and theories including risk management
Ability to work autonomously for the assigned activities with limited supervision
Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments
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]
Vos responsabilités : Dans le cadre d’un projet BBOC+, le Quality SME est en charge :
d’un package d’équipements / systèmes dont il/elle est responsable de :
S’assurer que les requis GMP soient intégrés dans le design des équipements / systèmes.
Participer au processus de sélection des vendeurs.
Assurer un oversight qualité tout le long de la phase de construction / installation / mise en service.
Développer les procédures permettant leur utilisation et leur maintenance.
Assurer le release avant utilisation GMP.
S’assurer du respect du timing et de la qualité et aider au respect des budgets.
d’un ensemble de processus qualité (Engineering) dont il/elle est responsable de :
S’assurer que les procédures sont à jour.
S’assurer que la stratégie de training soit définie.
S’assurer de la correcte implémentation tout au long du projet
de groupes de travail liés à l’intégration de la phase d’extension avec les processus actuels du B7 dont il/elle est responsable de :
Définir le scope et les membres (core team et ad-hoc team).
Leader les discussions du groupe de travail pour dérouler le plan d’action.
Assurer un reporting adéquat.
Votre profil :
Master’s degree in Sciences
Minimum 8 ans d’expérience en production / qualité dans le domaine biotechnologique.
Bonnes connaissances des requis règlementaires biotech.
Bonne habilité à challenger et à défendre ses opinions.
Parler Français et Anglais couramment
Notre offre : Jefferson Wells vous propose un contrat permanent en tant que consultant avec un package salarial attractif et vous donnera accès à des formations en compétences techniques et en soft skills. Nous serons votre partenaire de carrière à chaque étape de votre parcours. Vous êtes intéressé par ce poste ? Nous vous invitons à postuler ou à m'envoyer votre CV à l'adresse suivante : [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]
Bonnes connaissances des procédés de production Biotechnologiques (Upstream et/ou Downstream et/ou Logistique (Media/Buffer).
Bonnes connaissances des processus de nettoyage (CIP/COP), de stérilisation (SIP), d’environmental monitoring, de thermal mapping de zone à température contrôlée.
Notre offre : Jefferson Wells vous propose un contrat permanent en tant que consultant avec un package salarial attractif et vous donnera accès à des formations sur des sujets techniques ainsi que sur les soft skills. Nous serons votre partenaire de carrière à chaque étape de votre parcours. Vous êtes intéressé par ce poste ? Nous vous invitons cordialement à postuler ou à m'envoyer votre CV à l'adresse suivante : [email protected]
Your responsibilities: As a Gene Therapy Quality Partner, you will support the Genesis project GMP Readiness program to timely obtain health authorities authorization to manufacture Gene Therapy clinical batches in the new facility pilot plant.
Drive the implementation of the new Gene Therapy facility quality operational procedures into existing QMS (change control, deviation management, release procedures, training, etc).
Support the documented assessment of the GMP & Operations Readiness program progresses according to project key milestones.
Support management of materials & product specifications, execute incoming materials release
Support the consolidation and writing of the Contamination Control Strategy
Drive the supplier’s qualification program
Establish and drive the inspection readiness program
Drive the preparation of the new Gene Therapy Facility Site Master File
Your profile:
Scientific master’s degree or equivalent
At least 5 to 8 years of experience of QA oversight in a GMP manufacturing environment
Experience of a new manufacturing facility seeking Health Authorities certification
Good knowledge of Biopharmaceuticals or Gene Therapy manufacturing
Experience in health authorities’ inspections
Strong Knowledge of GMP, CFR, Eudralex for Biopharmaceutical manufacturing
Fluency in English and French
QP Registration in Belgium is an asset
Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
Strong understanding of a risk-based approach
Able to understand customers’ needs and technical requirements
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]
Development of an in-depth understanding of the process chemistry and process engineering relating to the postholder's projects and an awareness ofchemical aspects of other projects within the group.
Execution of preliminary literature surveys leading to the definition of experimental programs. Planning, preparation and implementation of experimentaland/or scale-up studies using standard and specialized equipment and techniques(laboratory, kilo-lab & pilot plant). Initiation, monitoring and work-up of reactions aswell as isolation and purifications of materials (laboratory, kilo-lab and pilot scale).
Identification and definition of specific analytical tests in order to facilitate effective process development and ensure optimum product quality. Submission ofmaterials for analysis and/or generation of analytical data using standard laboratoryanalyses. Interpretation of analytical results from these tests for laboratory, kilo-laband pilot activities.
Ensuring good record keeping with respect to all laboratory, kilo-laboratory and pilot plant activities, particularly regarding patentability & regulatory requirements.
Preparation of detailed reports covering specific work programs on completion of the activities or whenever appropriate. Preparation of high quality documentationin support of potential companies patent applications and other publications as requested.
Participation in the transfer of chemical processes from laboratory to kilo-lab, pilot plant and/or production, under the direction of Science lead.
Full compliance with all departmental and site-specific Health, Safety,
Environmental and Quality regulations, systems and procedures covering laboratoryand scale-up activities. Additional requirement of full compliance with all companies business policies and guidelines.
Participation in and active contribution to departmental and/or technical meetings as required. Responsibility for ensuring compliance with actions established during these meetings.
Participation in, contribution to and/or completion of other initiatives, tasks or activities as requested or assigned by the project/science lead, group head, or department Director from time to time
Your Profile
Knowledge in general organic chemistry both theoretical and practical;chromatography (HPLC/UPLC/GC) and characterization techniques (UV; PAT;NMR and MS spectrometry); Automatized equipment, typical lab equipment.
Knowledge in process analytical technology (PAT) for monitoring and characterization
Knowledge in crystallization process development and characterization
Ability to participate to process development as scientist in specific area of expertise as process characterization, optimization, understanding, industrialization and investigation QbD development of the different compounds in development.
Experience in ensuring that all developed processes can be scaled up to a 60 L reactor and perform the syntheses at this scale in the Kilolab.
Experience in transferring to the Pilot Plant is an asset
Understanding of regulatory environments
Good understanding of the results, good record keeping and reporting with respect to technical activities.
Ensure that all processes are in compliance with internal safety rules.
Ability to ensure a good literature survey on the projects by using all available research methods and tools.
Ability to find technical solutions and activate all appropriate internal /external experts to solve the issue
Ability to independently manage R&D tasks in order to meet deadlines within given constraints in resources, e.g. headcount, equipment, time, etc.
Demonstrated flexibility and agility to learn and acquire new competencies
Demonstrated ability to participate in the communication and information exchange
Demonstrated good interpersonal, verbal, and written communication skills with ability to balance multiple priorities
Work transversally across projects and groups in line with the needs of the business and as part of the Drug Substance Process Sciences organization and wider CMC
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]
