Scientist, Injectable Drug Product Process Development
Walloon Brabant – Contracting
Major Responsibilities
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 (e.g. filter selection and sizing, target fill volume assessment, compatibility assessments, clinical blinding, etc.) ;
Capture and analyze 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 the client's 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.
Profile
Bachelor's Degree ;
2–3 years of experience in manufacturing or production support ;
Knowledge of fill & finish processes (even indirect) ;
Ability to work independently after a few months ;
Scientific critical thinking ;
Clear and transparent communication ;
Motivation and energy ;
Fluent English (documents, meetings, interactions) ;
Scientist grade.
Nice to Have:
Experience with syringes or injectable liquids ;
Experience working with CMOs ;
Understanding of fill & finish steps and their impact on the product ;
Ability to translate needs into lab language/protocols ;
Experience writing scientific reports.
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]
Develop and maintain automation documentation and software for all assets lifecycle ;
Attend to workshops to ensure alignment with the different companies and disciplines ;
Participate to the overall automation strategy ;
Follow ‘up Automation Integrator and Vendor Packages during development and execution ;
Put in place strong collaboration with manufacturing entities to deliver strong support and expertise ;
Verify Automation Integrators deliverables and anticipate any cost increase ;
Attend to FAT / SAT / commissioning / Validation ;
Ensure automation deliverables follow GMP and HSE regulations ;
Proactively report and manage risks ;
Review verification protocols ;
Be part for 24/7 guard support in hybrid model with Automation Integrators (L1/L2) ;
Organize operator training ;
Perform handover to operation and support team ;
Manage punch list related to its packages / buildings.
Profil
Master's Degree
5 years in Engineering projects in Process Automation
Proven involvement in significant engineering projects, including risk/mitigation management ;
Good level of French and English ;
Strong knowledge of AVEVA System Platform (SP), OMI and RM with hands-on experience in troubleshooting and production support ;
Strong knowledge of SSMS (SQL Server Management Studio) for troubleshooting, running queries to extract and analyze data for investigations ;
Basic knowledge of SSRS (SQL Server Reporting Services) applied to designing, maintaining and troubleshootings generation of reports for operational needs ;
Basic knowledge of Aler AMS application with experience in configuring and monitoring the system for production support ;
Strong knowledge in design, execution and C&V ;
Ability to translate and present expert concerns to facilitate decision ;
Ability to work in highly dynamic environment and to handle challenging situations ;
High communication skills (leadership, negotiation, change management, facilitation) ;
Able to reach team decision and high sense of responsibility ;
Ability to challenge and argument ;
Ready to travel a limited period of time ;
Nice to Have:
IT knowledge (network, PC management) ;
Ability to communicate with IT ;
Pharma experience ;
Awareness of quality/regulatory 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]
Your responsibilities: The company is seeking a Solutions Quality Lead to join the R&D Quality department, focusing on Good Laboratory Practice (GLP) compliance. The role is critical for supporting audit management, inspection readiness, and process improvement in pharmaceutical development.
Manage and deliver GLP, GCP Lab, Toxicology, and Pharmacokinetics audits.
Assign and ensure completion of audits supporting candidate development.
Conduct or peer-review study plans, amendments, and reports.
Contribute to process improvement by reviewing global regulations and updating SOPs and policies.
Investigate non-compliance issues and facilitate stakeholder discussions for action plans.
Support inspection readiness and participate in inspections by authorities or business partners.
Archive audit documentation and follow up on CAPA actions.
Represent R&D and PV Quality at meetings and provide guidance to team members when requested.
Your profile:
Minimum 3 years of experience required, ideally 5 years.
Experience must be in pharma, specifically GLP auditing in small molecules.
Strong English language skills and French.
Ability to work autonomously and transparently, with strong communication skills.
Energy and motivation to raise issues and drive results.
Excellent planning, organizational, presentation, training, communication, and interpersonal skills.
Experience in influencing and collaborating within a global matrix organization.
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]
Management of end to end clinical distribution operational activities, including coordination of orders following QP release, shipment requests & prioritization, returns, destruction and study close-out activities.
Drive strong partnership with stakeholders (internal and external).
Drive the coordination & prioritization for shipment planning with CSC stakeholders.
Ensure close-out activities are performed in a timely manner.
Responsible to ensure timely follow-up on distribution activities with carriers.
Contribute to distribution processes improvement, in collaboration with internal and external stakeholders, supporting OE & process improvements initiatives.
Act as primary contact for internal distribution activities (or forecast), ensuring any reported issues and handled correctly and communicated to stakeholders in a timely manner.
Review and archiving of trial GMP/GDP related documentation.
Support in writing procedures, deviations, investigations, change controls and resolve issues related to distribution.
Ensure the appropriate execution of CPLO procedures and compliance with GMP's and GDP's.
Understand regulation and adhere to established procedures to ensure compliant distribution.
Responsible for invoice management of Clinical Trials transport invoices.
Profil
Bachelor's Degree
A minimum of 3 to 5 years of experience in logistics is required
Experience in the pharmaceutical sector.
Strong knowledge of GMP (Good Manufacturing Practice).
Experience in logistics, ideally with clinical trials.
Fluency in both English and French.
Dynamic, team-oriented mindset.
SAP (logistics module) knowledge is a plus.
Good IT skills, quality mindset, and analytical/structured approach.
Nice to Have:
Experience with clinical trial archiving processes.
Knowledge of Clinical Trial Supplies practices.
Cold chain expertise.
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]
Attend kick-off meetings and present sourcing strategies
Lead procurement packages and coordinate with project teams
Manage RFI/RFQ processes and analyze bids
Negotiate contracts and terms with suppliers
Track procurement progress and report to stakeholders
Ensure sustainability and compliance in sourcing decisions
Your profile:
Minimum 3 years’ experience
Experience in procurement and contract negotiation
Proven success in CAPEX projects (up to €50M) – Process EQUIPMENT.
Bachelor's degree minimum
Strong communication and stakeholder management skills
Ability to deploy standard processes and solve problems
Autonomous yet collaborative
Comfortable in technical and industrial environments
Precise and detail-oriented
Fluent in both French and English
Nice to Have:
Affinity for industrial processes and equipment
Experience in Pharma industry
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]
1. Apply the company's Health and Safety policy. 2. Ensure a safe working environment to meet campus safety objectives.
MANAGEMENT
1. Increase team’s competency by ensuring adequate training, coaching and development of team members in function of the team and people potentials.
OPERATIONS
1. Participate to daily/weekly meetings with team and/or stakeholders to follow-up on the planning and give information. 2. Ensure required corrective actions are taken and put in force. 3. Implement, follow-up and communicate on KPI with its related corrective actions. 4. Inform stakeholders and/or head of the department if deviations from the day-to-day-planning occur. 5. Be prepared and participate actively to weekly/monthly planning meetings, propose solutions, demonstrate creativity and pro-activity in order to ensure adherence to plan and performance. 6. Be accountable for a pro-active collaboration with different stakeholders. 7. Support the general objectives of the department in accordance with the company’s objectives and formally assess the results with the adequate KPI (Key Performance Indicators) : safety, quality, lead time, social and environment. 8. Ensure continuous feedback with each team members.
QUALITY
1. Participate / do the update of procedures and instructions. 2. Ensure Follow-up or is responsible of corrective actions and preventive actions. 3. Participate to the preparation, the follow-up and the realization of the audits. 4. Ensure adequate training/coaching of the team members.
Profile:
Minimum 5 years in a QC laboratory environment
Experience in GMP-regulated environments
Strong knowledge of QC lab operations
Fluent in both French and English
Strong communication, teamwork, prioritization, and diplomacy skills
Flexibility in case of emergencies
Full-time availability
Bachelor's or Master's degree in a relevant scientific field
Nice to have:
Skilled in leading lab investigations and writing specifications/sampling plans
Acts as Subject Matter Expert (SME) for stakeholders
Proactive, improvement-oriented, and collaborative
Able to manage planning, KPIs, and cross-functional communication
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 alignment between process needs and equipment validation.
Interact with both French-speaking and English-speaking stakeholders.
Provide support in case of troubleshooting.
Phase 2: Procedure Writing:
Collaborate with production teams (mainly French-speaking).
Write technical and pragmatic documents for production teams.
Phase 3: Strategic Participation:
Participate in cross-functional discussions regarding campaign setup.
Potential involvement in more strategic topics depending on the candidate’s level.
Your profile:
Knowledge of upstream processes (development, engineering, technology).
Fluent in French and English.
Strong writing skills.
Understanding of equipment and processes (expertise in validation not required).
Ability to interact with diverse teams (validation, production, stakeholders).
Nice to Have:
Experience in equipment validation.
Specific knowledge of processes involving mammalian cells and viral vector production (AAV).
Experience in writing technical procedures.
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]
Assist to Kick-off meetings, prepare and present sourcing approach.
Lead/participate/coordinate Procurement Packages activities in collaboration with Project team.
Handle full RFI / RFQ processes as appropriate as per Procurement Plan.
Organize presentation of offers and perform commercial analysis of bids (Total Value of Ownership optimization, business cases comparison).
In collaboration with the legal department, set up contractual agreements ensuring appropriate company protection (risk analysis – KPI setting).
Negotiate terms & conditions with suppliers.
Decide on vendor shortlist for negotiation, prepare and communicate award decision.
Consider sustainability criteria to ensure that the products and services purchased have the lowest environmental (during their entire life cycle) and most positive social (child labor provision, occupational health and safety, regulatory compliance) impact.
Communicate progress and prepare appropriate reports as needed by Project leads, Owner’s Rep, etc.
Manage Contract Execution (if required by the project)
Manage suppliers contractual and commercial relationship to meet main project drivers and secure project quality, the budget and the schedule by:
Supporting the project team as soon as potential issues arise and entering proactively into discussions with key partners.
Following up and negotiating changes of scope, including contract amendments.
Reporting on a weekly basis procurement status to the Project Manager and Engineering Lead.
Preparing and leading regular governance calls with the main suppliers.
Approving contractual milestones payment release.
Handling provisional acceptance and close out of accounts with suppliers.
Ensure consistency and adequacy of documents such as Performance Bonds, Bank guarantees, Invoices, confidentiality agreements.
Report packages status to the company Category Lead and to Project Management, as required, highlighting progress and areas of concern.
Track savings versus set targets and complies with reporting guidelines.
Comply with the company and project strategy, procedures, guidelines and software usage.
Your profile:
Minimum 3 years required
Experience in procurement and contract negotiation
Proven success in CAPEX projects (up to €50M) – Process EQUIPMENT.
Bachelor's degree minimum
Strong communication and stakeholder management skills
Ability to deploy standard processes and solve problems
Comfortable in technical and industrial environments
Fluent in both French and English
Nice to Have : Experience in Pharma industry
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]
Département In vivo Pharmacologie – spécialisé dans les études in vivo, études de comportements sur différents rongeurs principalement souris et rats
Collectes de tissus, administration de composés et check effet sur le comportement des animaux
Préparation des réactifs et gestion du laboratoire
Votre profil ?
Master ou Doctorat en Sciences ou équivalent
Au moins un an d’expérience In vivo (meurins)
Titulaire du Felasa B
Connaissances en Excel
Excellentes compétences en Anglais
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]
Laboratory work and writing of methods and protocols.
Use of analytical techniques: chromatography (size exclusion, reverse phase, affinity, ion exchange, HILIC, HIC), capillary electrophoresis (CGE, CzE, iCE, MauriCE).
Collaboration with the team for theoretical and practical training.
Communication with the company contact point, planning, and technical experts.
Development, validation, and transfer of methods.
Design of experiments.
Autonomous management of laboratory activities related to method development, validation, and transfer.
Contribution to release and stability testing according to project needs.
Preparation, review, and approval of documentation (procedures, protocols, reports).
Analysis and verification of results.
Presentation and discussion of results in project team meetings.
Compliance with GMP/HSE rules and regulatory requirements according to product development phases.
Your profile:
3-5 years of experience in the pharmaceutical industry.
Good knowledge of protein chemistry.
Expertise in at least one analytical technique (chromatography or capillary electrophoresis).
Knowledge of Empower software.
Written and spoken French, written English.
Understanding of the principles behind the methods (not just execution).
Expertise in analytical method development and validation.
Ability to author and review comprehensive and accurate procedures, protocols, and reports.
Nice to Have:
Experience in biochemistry and separation of biological matrices.
Knowledge of separation techniques applied to proteins.
QC experience with understanding of methods.
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]
