Perform analyses on raw materials, intermediates, and finished products (stability, IPC, clinical release, investigations).
Develop and validate analytical methods for different phases of product development.
Ensure stability and clinical release testing for phases I and II.
Participate in analytical method transfers to QC and subcontractors.
Use lab software: Empower (Waters), GLIMS, e-noval, Veeva.
Analyze results with a critical mindset, ensuring consistency with previous data.
Follow procedures, use validated methods, and maintain analytical equipment.
Work under the supervision of a project scientist, collaborating with – Chemical Process R&D and Drug Delivery Design teams.
Must-Have Qualifications:
3 to 5 years of experience in analytical chemistry (small molecules).
Bachelor’s degree in analytical chemistry.
Technical expertise: HPLC/UPLC, GC, detection via UV/Vis, RI, MS.
Familiarity with USP/EP pharmacopoeias.
Proficiency in Empower software (mandatory).
Strong critical thinking, scientific curiosity, and ability to challenge results.
Good understanding of technical written English.
Experience in the pharmaceutical industry.
Familiarity with other chromatography data systems.
Our offer: Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Lead various ongoing projects related to the implementation of new analytical equipment (computerized and non-computerized) in-line data integrity requirements and Good Science Practices (GSP), Good Manufacturing practices (GMP).
Prepare documentation (protocols, reports, URS, user guide/SOPs and other qualification -related documents)
Support system owner (SO) / Process Data Owner (PDO) in the following task:
Identifying critical data and critical steps throughout the business processes
Defines appropriate processing of data in accordance with data integrity principles
Ensures that equipment (CS and non-CS) is fit for purpose
Determines access criteria and related restrictions
Support the definition of data flows and archiving strategy
Be the Single Point of Contact (SPOC) for analytical-related equipment for Engineering team, engineering of fice and equipment CQV team
Follow the GMP/GSP procedures in place as well as the Biosafety/HSE rules in the laboratory
Work in close collaboration with users, IT, qualif/valid, engineers and GMP/GSP QA experts
Work according to the agreed timelines
Your profile:
Master's Degree
Demonstrate a high level of autonomy, flexibility and a proactive mindset.
Ability to communicate effectively with good French and English skills
Technical knowledge analytical techniques required to study viral vector Gene Therapy Products is an asset (UPLC, Mass spectrometry, light scattering, electrophoresis, qPCR, spectrophotometry , …
Experience in GMP/GSP analytical equipment qualification and release (URS and SOPs writing, validation documentation review, …)
Ability to multi-task and to openly exchange results, observations, and possible improvements
Demonstrate ability to analyze data, with good attention to detail, and excellent record keeping and documentation
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]
Bioprocess System specialist Contracting – Brabant Wallon Your Responsibilities:
Handle troubleshooting in production, particularly when issues arise with cleaning or production equipment.
Participate in task force meetings to address and resolve production-related problems.
Work on multiple projects simultaneously, with tasks changing depending on the project's phase.
Review documentation during the early stages of projects, and visit production areas to monitor CIP (Cleaning in Place) sites to ensure all systems are functioning properly.
Be adaptable, as each day varies greatly based on the needs of ongoing projects.
Your Profile:
Experience: A minimum of 2 years of experience in a pharmaceutical company, specifically in cleaning process equipment. Experience in USP or DSP processes is a plus, as long as you have a basic understanding of pharmaceutical equipment cleaning requirements.
Pharma Experience: Strong background in the pharmaceutical industry is a must, ideally with a focus on clinical operations. Candidates with cleaning experience are preferred. Pharmaceutical experience is critical as training on GMP zones, attire, and behavior can be time-consuming.
Autonomy & Proactivity: You must be able to work independently without constant supervision. The team is looking for someone who is proactive and can handle challenges autonomously.
Experience with managing deviations and investigations, handling change control, implementing CAPAs (Corrective and Preventive Actions), and developing cleaning strategies is highly valued.
Languages: French proficiency is essential for daily communication, as most protocols and reports are in French. While basic English skills can be helpful, English is not required for the role.
Our offer: Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Quality Partner Brabant Wallon – contracting Your responsibilities?
This team manages the quality of products distributed internationally through subsidiaries or commercial partners. The QA Partner acts as the main quality contact between the company and its partners, ensuring bilateral communication and compliance with quality agreements.
Act as the main quality contact between the company and commercial partners.
Manage quality complaints received from partners.
Handle deviations (e.g., temperature excursions, damaged products).
Monitor and assess Change Controls and notify partners when necessary.
Work autonomously on a portfolio of partners while collaborating with the team.
Your profile?
You have a Scientific or Engineering Degree (or equivalent acquired through professional experience)
Minimum 2 years experiences in Quality Assurance in a pharmaceutical environment
Experience in managing external suppliers or partners.
Knowledge of quality agreements.
Proficiency in handling complaints, deviations, and Change Control processes.
Good command of English (main working language).
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.
Logistic Compliance and Process Excellence Manager
Contracting – Brabant Wallon
Your responsibilities:
Manage and lead the backlog of deviations to resolution.
Understand the deviations, logistics and warehousing processes, to understand the description and history of each issue, including the work done so far.
Build and lead suitable teams for efficient collaboration
Conduct comprehensive root cause analysis to accurately identify the source of each issue.
Collaborate with stakeholders to develop and implement action plans that prevent recurrence.
Challenge existing analyses and conclusions where necessary, ensuring accuracy and completeness.
Coach the current logistic team, enhancing process understanding and their capability in handling their responsibilities, deviations and root cause analysis.
Your profile:
Bachelor's Degree
Strong experience in dealing with deviations and performing root cause analysis.
Extensive experience with GMP warehouse management and inventory systems (SAP)
Experience in coaching junior team members, enhancing their skills and effectiveness.
Proven ability to challenge existing work and provide accurate, complete analyses.
Ability to manage and challenge the content of deviations and engage in productive discussions with stakeholders.
Maturity, dedication, and the right mindset to drive continuous improvement.
Excellent analytical and problem-solving skills.
Strong communication and interpersonal 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 or send me your CV, [email protected]
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]
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
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.
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.
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]
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]
