Analytical Development Analyst Brabant Wallon – Contracting What are your responsibilities? This team’s primary responsibility is to develop, validate and transfer to internal and external partners, robust and efficient physico-chemical methods, according to the required regulatory requirement standards. The team also provides analytical support and expertise to process understanding and process validation of biological and chemical processes and is responsible for transferring methodology, technology, data and preparing regulatory submissions with business partners. Scope of the mission: The primary goal of the mission is to provide scientific expertise to contribute to contribute to manage physics-chemical method development activities from early clinical phases to commercial. The main techniques used are Liquid chromatography (Size-exclusion, Reverse-phase, affinity, Ion exchange, HILIC or HIC) or electrophoresis capillary (CzE). Major accountabilities: The main activities of this position will be:
Design experiments
Autonomously manage and perform daily laboratory activities related to method development, validation, transfers
Contribute to release and stability testing related to the project as appropriate.
Prepare and review/approve documentation (procedures, protocols, reports)
Analyze results.
Verify data.
Present/discuss results in project team meetings.
All these activities will be performed in compliance with the GMP/HSE rules and with the regulatory requirements for each development phase of the product. Who are you?
Master’s or bachelor’s degree in biochemistry or in analytical chemistry
At least 5 years of experience in the pharmaceutical industry
Strong and proven laboratory skills
Good knowledge of protein chemistry and techniques for separating polymers in a protein matrix
A good practical experience and expertise in at least one of the analytical techniques used in the laboratory: chromatography (Size-exclusion, Reverse-phase, affinity, Ion exchange, HILIC or HIC) or electrophoresis capillary (CzE)
Expertise in analytical method development and validation
Ability to author and review comprehensive and accurate procedures, protocols, and reports.
A good knowledge of GLP/GMP rules.
A good level of English is recommended for reports and oral communication.
Ability to handle multiple priorities and/or prioritization.
Interpersonal skills to communicate and maintain good working relationships within the team and with internal/external customers/partners.
Ability to work in a matrix and customer-oriented environment.
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.
What are your responsibilities? This team’s primary responsibility is to develop, validate and transfer to internal and external partners, robust and efficient physico-chemical methods, according to the required regulatory requirement standards. The team also provides analytical support and expertise to process understanding and process validation of biological and chemical processes and is responsible for transferring methodology, technology, data and preparing regulatory submissions with business partners.
Scope of the mission: The primary goal of the mission is to support the activities of the laboratory according to the agreed quality standards and timelines.
The main activities of this position will be:
Participate and ensure compliance with the lab housekeeping/5S program
Perform daily laboratory activities (reagents stocks, ordering, daily calibrations of instruments, preparation of mobile phases…).
Work with other analysts in sample management (receiving / shipment / aliquoting…)
All these activities will be performed in compliance with the GMP/HSE rules and with the regulatory requirements for each development phase of the product.
Who are you?
High School degree with scientific orientation
Previous laboratory skills in biotech industry is a plus
Knowledge of GMP standards in laboratory is plus
Good interpersonal, verbal, and written communication skills
Knowledge of English (ability to read scientific documents)
Well organized, flexible, meticulous and rigorous, proactive, with a strong team spirit
Able to work in a multicultural environment.
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.
Bio DS Operations Quality Specialist Brabant Wallon – Contracting What are your responsibilities? The Bio DS Operations Quality Officer will oversee Upstream/Downstream/Media and Buffer quality assurance activities specifically related to manufacturing operations within new commercial biologicals drug substance facility. This role is crucial in ensuring compliance with internal standards. The position also involves driving continuous improvement in quality processes to uphold the highest standards of product quality and safety. Additionally, this role involves connecting to appropriate stakeholders to ensure the alignment with production. Quality Assurance:
Review and approve deviations, corrective and preventative actions, and change controls.
Review and approve Batch records.
Ensure escalation of quality problems to the appropriate levels of management following the standards set by the QMS.
Regulatory Compliance:
Participate in reviewing Annual Product Reviews.
Who are you?
Bachelor or Master’s Degree in science (Biotechnology, Chemistry, Pharmacist,…)
Minimum of 5 years’ experience in GMP Environment.
Demonstrated strong experience in biologicals drug substance operations (business and/or quality).
Demonstrate good communication skills with stakeholders.
Fluent in French and English.
Resistant to stress.
Ability to create support for training
Knowledge in other Biomanufacturing processes can be a advantage (validation, maintenance, metrology,…)
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.
Pharma MSAT Quality Lead Contracting – Walloon Brabant Your responsibilities?
Establish and build a network with the company key stakeholders in relation to Internal and External A/MSAT for Pharma Drug Substances and Drug Products.
Provide expert QA advice, support and management for technical operational QA and general QA matters associated with Internal & External Pharma A/MSAT, with the following focus: 2nd line troubleshooting (process and analytical)
Process improvement and life cycle management strategy within regulatory file boundaries (process and analytical)
Process industrialization and technical transfers (process and analytical) within commercial manufacturing facilities
Complex investigations and CAPA plans implementation (process and analytical)
Process validation oversight and continuous process verification (CPV)
Implement the established governance model and process for Quality oversight of Internal and External A/MSAT for Pharma Drug Substance and Drug Products which fosters continuous quality process improvement, optimized resource utilization and key indicator-based performance monitoring
Support assignments associated with the Products and represent the team in transversal projects and initiatives
Work closely with Global Quality teams and Business stakeholders in an effective and efficient way
Promote Best Quality Practices throughout the External & Clinical Supply Quality team and where possible business stakeholders.
As required, provide Operational QA support to other projects or vendors (e.g. Quality agreement preparation, follow up on audit observations and CAPA plan implementation, …) to support other team members or the wider team.
Upon request deputize for the Head of Pharma MSAT Quality and other Pharma MSAT Quality Leads in times of absenteeism (e.g., vacation, illness)
Work in accordance with HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of business and professional career development
Your profile?
You hold a degree in a Master in a Scientific/Engineering domain
Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations.
Has good background knowledge of the pharmaceutical industry from a business and technical perspective. Operational experience, along with a manufacturing QA background and strong technical knowledge, is a key asset.
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.
Must be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.
Must have the ability to manage projects/ activities across global geographies within the area of expertise. Be capable of leading and motivating teams and demonstrate professional maturity in difficult situations.
Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally, especially at senior management levels.
You speak fluently 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.
Support the pre-clinical CNS small molecule, antibody and gene therapy projects
Strengthen the capabilities in molecular biology tools to support pipeline projects.
Designing and implementing molecular biology tools, and bespoke read-outs.
Demonstrate expert knowledge in designing plasmids, shRNA, and CRISPR guides and register them in Benchling software.
Provide high-quality data and scientific support, keeping up to date with relevant scientific literature and proactively searching for new methodologies.
Your profile?
Master’s degree in the field of molecular biology, cell biology, or related. She/He will be skilled in using molecular biology tools, DNA/RNA extraction, RT-qPCR and cell culture related activities.
Expert knowledge in designing molecular biology tools: plasmid, shRNA and CRISPR guide design and registration in Benchling software
Expertise in RNA/DNA/miRNA extraction methods and QC (Tapestation)
Knowledge of PCR techniques: qPCR, RT-qPCR and ddPCR
Expert in cell line culture, expansion and transient transfection
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.
Distribution Quality Partner Contracting – Walloon Brabant
What are your responsibilities?
Operational Quality Support
Ensure cGMP/GDP and related regulatory requirements are successfully implemented and maintained within internal quality system.
Review and approve investigations, deviations, change controls, complaints, procedures or other process-related documents
Vendor Quality Management
Support GDP vendor management activities – periodic performance oversight, and resolution of quality issues, including writing and reviewing Quality Agreement.
Expert GDP Oversight
Act as an experienced SME for GDP matters within the team, supporting the team with interpretation of regulations.
Continuous Improvement
Identify opportunities to optimize distribution Quality processes and ways of working; propose and implement improvements to increase efficiency and inspection readiness of GDP activities.
Who are you?
A minimum of 5-8 years of experience in the pharmaceutical industry, previous experience in Quality in GDP
Deep understanding of EU GDP Guidelines (2013/C 343/01) and relevant cGMP concepts.
Strong knowledge of global distribution models (3PL, carriers, warehouses, temperature-controlled distribution).
Previous experience as Responsible Person is an asset
Ability to support daily Quality decisions (go/no-go for shipments, deviation triage, documentation review, write and review quality agreement).
Take ownership of topics and drive them to closure.
Analytical mind-set and very good organizational skills
Fluent in 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 will support the development and delivery of ADA immunogenicity assays and associated data sets in support of our biologics (NBE) and/or gene therapy pipeline.
Work within the bioanalytical teams to optimize experimental design, sample analysis, data interpretation and report generation.
Have an opportunity to support the delivery of other bioanalytical methods including, such as cell-based assays.
Your profile:
At least a BSc in a biological discipline with 1 year of hands-on experience in Bioanalysis.
Experience in developing and validating assays to assess immunogenicity.
Demonstrate in-depth technical understanding of ligand binding assays, particularly on platforms like MSD (Gyrolab, ELISA), dealing with complex ADA assays.
Experience with assessing and/or overcoming Drug, Target interference, presence of Pre-existing ADA, characterization of multi-domain specificity in immunogenicity assays.
Ensure adherence to quality standards while supporting the delivery of assays and critical data sets within project deadlines.
Ability to generate, analyze, interpret, and present critical data sets.
An ability to work in a matrix and communicate clearly.
Be agile and flexible in adapting to changing projects and organizational priorities, aligned with project deadlines and departmental needs.
Global Paper archivist Governance Lead & Process Data Owner
Contracting – Brabant Wallon
Your responsibilities: The company is creating a new global role to take full ownership of paper archiving governance across all sites and affiliates. Although a global paper archiving process already exists, its local implementation has not been consistently followed or monitored, leading to gaps, risks, and deviations. The objective is to harmonize, structure, and operationalize paper archiving practices globally, ensure inspection readiness, and reduce regulatory, data privacy, and operational risks. The role will also act as Process Data Owner, the paper archiving system already live in several countries and being extended further.
Interacting with global and local stakeholders to understand how paper archiving is implemented at site level.
Assessing gaps based on existing assessments and defining practical action plans.
Building and animating a community/network of archivists.
Supporting and governing the Doxis system (validation status, access, data structure, user support).
Reviewing and aligning retention schedules, procedures, and documentation.
Managing topics related to external archiving vendors (governance, access, quality agreements).
Preparing for inspections, managing deviations and CAPAs, and driving continuous improvement initiatives.
The role requires autonomy, initiative, and a “helicopter view” of global archiving activities.
Your profile:
Minimum 5 years of experience in records management or archiving within a regulated environment, with enough experience to work independently and proactively without close daily supervision.
Solid experience in paper archiving / records management.
Experience in a regulated environment (preferably pharmaceutical or healthcare).
Strong understanding of data integrity principles (ALCOA+).
Strong communication skills and ability to work within a global network.
Comfortable working in English and French.
Strong organizational and stakeholder management skills.
Soft skills (initiative, autonomy, communication, project mindset) will be a key evaluation criterion.
Nice to have:
Knowledge of GxP environments and differences between manufacturing, non-clinical, etc.
Experience with document management or archiving systems.
Your responsibilities: 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.
Ensure adequate QA support for environmental monitoring, qualification, validation (including cleaning) and maintenance of the equipment, classified rooms, HVAC used in development manufacturing areas
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 development activities and products.
Support Change Control, Deviation, Events, Investigations,… 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:
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 is essential.
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
Fluency in French & 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 TST Portfolio Manager, you will use robust project/portfolio management and communication skills to set-up, structure & coordinate the CMC projects portfolio in line with the Assets & Patient Supply strategic plans for (a) given compound(s), managing the inter-connections across projects, ensure coordinated plannings & deliverables, the CMC resource allocation to projects, projects prioritization scenarios, budget, financial 10 years plan & tracking of actuals. This function implies close relationships within the technical teams, with Global Regulatory Affairs function within the Patient Evidence, Global Quality and Operational functions to ensure alignment with EU, US, JP & IM teams’ expectations. You are agile, structured, good team player, assertive, enthusiastic and with a positive mindset. As the TST Portfolio Manager, your main activities and roles & responsibilities will be the below:
Provide support and coaching to project managers for creating a master plan for their assigned project that includes timelines, required resources, the order of needed tasks, and the responsibilities of each project team member; the record and tracking of this information in the software applications
Work closely with the project managers to ensure that project milestones are met efficiently and within prescribed budget & resource constraints. Generate monthly reports on schedule adherence.
Consolidate all relevant CMC projects into a Portfolio per compound, ensuring appropriate links between projects, milestones and resources. Develop dashboard and KPI’s to drive efficiently the product portfolio inside the TST.
Identify any resource constraints proactively and drive the prioritization-making process in Patient Supply and CMC: prepare (and present) prioritization proposals to the Patient Supply LT or Asset LT for endorsement after TST agreement/discussion.
Coordinate budgeting effort to align Units, Operations, Functions and Practices to achieve consolidated product projects, budgets and monitoring.
Drive the increase of maturity on project management skills inside TST’s and identify areas of improvement for the CMC community.
Coordinate activities and knowledge gathering to ensure issues are addressed and escalated timely across the product portfolio stakeholders, with assertiveness and deep understanding of SME’s constraints on project/portfolio.
Your profile:
Minimum 5 years of project, program and/or portfolio management experience and in associated tools
Experience in enterprise planning/resource capability and systems. Knowledge of Planisware PPM tool is a strong asset
Solid understanding of the end-to-end CMC/Development (and associated disciplines) is a strong asset.
Languages: English & French
Robust knowledge of change management
A certification in PMP, PRINCE2, Agile, Lean or equivalent is a plus
Knowledge of the pharmaceutical environment; launch and life cycle management processes and the regulations applicable during development is an asset
