Scientist – Advanced Material Characterization and Investigations (AMCI) Contracting – Antwerp
Job Description As a Scientist, you will be part of the Advanced Material Characterization and Investigations (AMCI) group within the Analytical Development department. You will work in an international team of experts focused on advanced analytical characterization of pharmaceutical products and conducting analytical investigations within a global R&D context. You will join the Advanced Molecular Analysis (AMA) team, which specializes in structure elucidation using high-resolution mass spectrometry (HRMS), trace analysis, polymer characterization, and the analysis of complex molecules such as peptides and oligonucleotides. We are looking for a motivated chemist with experience in nitrosamine analysis. You will develop and implement innovative analytical methods, with a strong focus on chromatography and mass spectrometry.
Your Responsibilities
Develop and optimize analytical methods for the quantification of nitrosamines in pharmaceutical products, in compliance with applicable guidelines and quality standards
Perform in-depth root cause analyses with a focus on chemical reactivity
Collaborate closely with internal experts and multidisciplinary teams
Initiate and maintain collaborations with universities and research institutions
Ensure a safe working environment in accordance with EHS, GMP, and other regulatory requirements
Your Profile Education and Experience
PhD in analytical or organic chemistry, or a master’s degree with at least 6 years of relevant experience
Experience with nitrosamine determination is a strong asset
Solid expertise in mass spectrometry (Triple Quad, HRMS) is required
Familiarity with chromatographic method development is preferred
Knowledge of GMP and regulatory guidelines (ICH, EMA, FDA) is a plus
Fluent in English, both spoken and written
Personal Competencies
Eager to learn, scientifically curious, and able to work independently
Proactive and creative mindset
Strong collaboration skills in an international team environment
Result-oriented and detail-focused
Flexible, stress-resistant, and with a strong sense of responsibility
Our offer Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical skills and soft skills. We are your career partner every step of the way. Are you interested in this position? Send an email to [email protected]. We warmly invite you to apply.
Ensure the safety and well-being of study subjects at assigned clinical sites.
Support the operational execution of clinical trials and ensure high-quality data collection.
Perform trial activities in compliance with SOPs, GCP, and applicable regulatory requirements.
Be accountable for site performance and delivery of high-quality data within project timelines.
Assist Clinical Operations staff and site personnel to resolve issues and implement CAPAs when needed.
Verify that Investigator Site Files are maintained according to regulations and company procedures.
Support patient recruitment and retention activities.
Conduct site visits to ensure compliance with protocol and regulations.
Contribute to the internal communication of important clinical data and events.
Support the organization of Investigator meetings and study trainings.
Serve as a reliable resource for up-to-date site status knowledge for stakeholders.
Assist in the implementation of new clinical systems and processes.
Collaborate with Investigators, IRBs/ECs, vendors, and internal staff.
Comply with all applicable laws, regulations, and company compliance policies.
Profile
Bachelor’s Master’s , PhD in Life Sciences, Physical Sciences, Nursing, or Biological Sciences required.
Fluency in English, French and Dutch.
Previous clinical research experience required.
Experience in medical device monitoring (or equivalent) required.
Solid understanding of regulations and standards in clinical research and medical devices/combination products.
Relevant industry certifications (e.g., CCRA, RAC, CDE) are an asset.
Clinical/medical background is a plus.
Proficiency in Microsoft Office (Excel, Word, PowerPoint).
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]
Product Quality als onafhankelijke kwaliteitsautoriteit voor productgerelateerde kwalificaties en validaties van toegewezen producten.
Zorgen voor compliant en “right first time” productlanceringen binnen Quality Operations (QO).
Borgen van Regulatory CMC-compliance van plantprocessen met de registratiedossiers.
Optreden als kwaliteitsautoriteit (cGMP-conform) voor:
Process qualification/validation
Method validation
Filter validation
Component qualification
Raw material evaluation
DHF
Uitvoeren van data verification en QA-review van:
Initiële marketing authorization filings en variaties
Antwoorden op vragen van Health Authorities
Briefing documents voor scientific advice meetings
Uitvoeren van compliance checks van registratiedossiers (verschillende markten) versus site practice.
Correcte en tijdige implementatie van goedgekeurde regulatorische wijzigingen op de site.
Opvolging van approvals en commitments per markt.
Profiel
Masterdiploma in een wetenschappelijke richting (bv. Farmacie, Biomedische Wetenschappen, Bio-ingenieur) of gelijkwaardig (PhD).
Minstens 2 jaar relevante ervaring in de farmaceutische sector en/of medical devices.
Ervaring of sterke interesse in Quality Assurance/Compliance en CMC voor (bio)farmaceutische producten.
Quality mindset en pragmatische aanpak.
Uitstekende analytische en probleemoplossende vaardigheden.
Sterke mondelinge en schriftelijke communicatieve en sociale vaardigheden.
Wetenschappelijke kennis en vaardigheden.
Talen: vloeiend Nederlands en Engels.
Uitstekende kennis van cGMP, regulatorische richtlijnen en relevante regelgeving voor medical devices en combinatieproducten.
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]
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]
Execute technology transfer and upscale projects, in close collaboration with the company cross-functional teams (MSAT, External Manufacturing, Industrial & Analytical Leads, Quality, Regulatory etc.) and CMO.
Depending on the type of project, act as project manager or project team member.
Review and approve all project documentation (protocols, reports, risk assessments, forms,…)
Regularly track the project’s progress (timing, activities, resources, costs) against the plan and adjust as needed
Collaborate with the Quality team to ensure product quality and consistency, and manage deviations and change controls
Ensure manufacturing processes comply with regulatory requirements and industry standards
Edit CPV reports for the company products manufactured at the CMO and tested by the company
Participate in projects (upscale, technology transfer): assist to internal and external meetings, review/approve project documentation, manage deviations and change controls, report project progress internally
Provide the technical expertise to support the company’s CMO to ensure effective processes
Implement project management best practices throughout the project
Your profile:
Master’s degree in engineering, Pharmaceutical Sciences, or a related field.
Minimum of 5 years of experience in pharmaceutical manufacturing processes.
Technical and industrial expertise in sterile pharmaceutical products.
Experience in managing technology transfers.
Experience with compliance in a GMP environment.
Experience in project management
Fluent in French & English (written and spoken)
Subject matter expert in technical / manufacturing aspects related to sterile DP compounding and filling activities
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]
Projectmanagement en overkoepelende end-to-end validatie voor lancering van nieuwe mRNA-producten vanuit een nieuw RNA-platform.
Begeleiden van het volledige traject van concept tot lancering.
Samenwerken met interne en externe afdelingen (Engineering, Productie, R&D, Device Center of Excellence, Verpakking, QA, Procurement, Supply, Quality Projects).
Plannen, coördineren en prioriteiten stellen in een agile omgeving.
Motiveren en ondersteunen van project engineers om deadlines te behalen.
Rapporteren van projectstatus en voortgang in verschillende meetings.
Escaleren van risico’s en oplossen van problemen met verbeteraanbevelingen.
Toezien op naleving van afspraken, procedures en kwaliteitsstandaarden.
Stakeholdermanagement en communicatie op hoog niveau.
Opvolgen en uitvoeren van validatie-activiteiten in brede zin.
Profiel
Grondige kennis van GMP’s.
Kennis van design en productieprocessen van steriele geneesmiddelen.
Sterke affiniteit met end-to-end procesvalidatie.
Ervaring met validatie en procesoptimalisatie.
Ervaring met projectmanagement.
Kennis van onderzoeksmethodologieën voor root cause-analyse.
Sterke analytische vaardigheden en kritische mindset.
Perfecte beheersing van Nederlands en Engels.
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]
Assurer la coordination de la validation de projets majeurs en Drug Substance et Product
Assurer l’approche ‘state of art’ de la Validations du plan de validation (= stratégie de validation) jusqu’au Validation Summary Report, incluant :
Ecriture, revue et approbation de document de validation tels que les Risk Assessments, les protocoles IQ/OQ/PQ, les rapports IQ/OQ/PQ …
Coordination de l’exécution des protocoles
Votre profil?
Expertise en validation IQ/OQ/PQ et GMP
Connaissance en validation de produit injectable.
Solides connaissances en organisation matricielle et en gestion de projet.
Solides compétences en communication, organisation et influence pour travailler de manière transversale.
Parler couramment le français et l’anglais
Notre offre ? Nous vous offrons un contrat à durée indéterminée ainsi qu’un package salarial attractif. Vous profiterez également de l’opportunité de vous développer personnellement et professionnellement à travers des formations internes.
Key Responsibilities · Perform upgrades of outdated HMI systems to Siemens TIA Portal · Integrate Simatic Logon functionalities into systems · Convert existing WinCC configurations · Create and maintain validation lifecycle documents according to company and regulatory standards · Conduct testing of shopfloor systems · Assist with and execute validation protocols (IQ/OQ/PQ) · Develop Standard Operating Procedures (SOPs) · Provide support during operations/production startup of automation systems Qualifications · Proven experience with Siemens TIA Portal and Step 7 · Strong knowledge of GAMP5 and the System Validation Lifecycle · Solid understanding of the pharmaceutical industry and applicable standards (GxP, GDP) · Proficiency with Microsoft SQL · Fluent in Dutch and English, both verbal and written · Previous experience with project management in a pharmaceutical engineering 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. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
External Operations Quality Partner Brabant Wallon – Contracting What are your responsibilities?
Batch record review and administrative support (e.g., updating CoC, handling deviations, complaints, temperature excursions).
Provide timely and efficient GMP/GDP IMP Release function to all relevant internal project activities related to the development of the pipeline projects
Support compliance with all relevant and appropriate regulations and guidelines, such as those relating to GMP/GDP, health and safety, etc..
Support the systems and processes in place for the appropriate documentation of internal development activities and to maintain them in a manner compliant with regulatory and corporate requirements.
Ensure the Clinical Supply Quality activities are consistent across the range of different environments and teams supported (Vendors / Suppliers / in house).
Proactively support the activities of Clinical supply for relevant manufacturing quality systems (deviation close out / Change management / complaints / quality improvement).
Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions.
Provide support in the evaluation of Temperature excursions for IMP.
Management of Quality Complaints of IMP.
Ensure active participation in the selection, evaluation, approval and maintenance of Vendors for IMP activities, including leadership or support to conduct appropriate audits.
Oversight of Distribution activities (deviations, Business Review Meetings, assessments, etc…)
Ensure CMO (packaging and distribution vendors) quality documentation is accurate and up-to-date, by editing and reviewing quality agreements
Contribute the preparation of audits (internal/external, regulatory inspections)
Lead internal audits / Self-Inspections
Who are you?
5 years’ experience in QA/compliance experience in pharmaceutical regulated environment
Good knowledge of cGMP and relevant regulatory requirements (e.g US, European, Japanese)
Strong experience in batch review.
Quality mindset with a pragmatic and proactive approach.
Fluent in English is a must and French is a nice to have.
Experience working with CMOs and vendors.
Familiarity with GMP and GDP standards.
Experience with quality systems (deviation management, complaints, change control)
Familiarity with clinical packaging environments (vs. commercial) is a plus
Certified auditor status is a plus.
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 invite you to apply!
Doel van de functie: Als CSV Engineer binnen de ICS Automation afdeling ben je verantwoordelijk voor het waarborgen van de gevalideerde status van computer(systemen) en geautomatiseerd equipment in een hoog gereguleerde farmaceutische omgeving. Je levert ondersteuning en expertise op vlak van validatie, data integriteit en compliance. Daarnaast speel je een coördinerende en adviserende rol binnen diverse automatisatieprojecten.
Jouw verantwoordelijkheden:
Bieden van inhoudelijke ondersteuning en expertise op vlak van software en infrastructuurproblemen.
Adviseren van projectteams op basis van kennis van procedures, compliance vereisten en softwarevalidatie.
Bijdragen aan snelle en efficiënte implementatie van oplossingen.
Coördinatie van validatieactiviteiten binnen automatisatieprojecten.
Bepalen van de juiste validatieaanpak volgens interne procedures.
Opstellen van validatieplannen, -protocollen en -rapporten.
Uitvoeren van risicoanalyses gerelateerd aan computer(systemen).
Coaching en begeleiding van Project Engineers inzake validatieprincipes.
Uitvoeren en opvolgen van periodieke evaluaties (Periodic Reviews) van alle in scope computer(systemen) om continue compliance te garanderen.
Verantwoordelijk voor de opvolging van de Data Integrity status van geautomatiseerd equipment.
Fungeren als aanspreekpunt voor Data Integrity gerelateerde vragen en ondersteuning binnen de site.
Mee bewaken van de DI-vereisten als onderdeel van onze “license to operate”.
Jouw profiel:
Masterdiploma Industrieel, Burgerlijk of Bio-ingenieur met sterke interesse in automatisatie en softwarevalidatie.
Grondige kennis van en/of ervaring met softwarevalidatie, compliance en CSV-processen in een GMP-omgeving.
Vlot kunnen werken met Microsoft Office tools.
Vloeiende kennis van zowel Nederlands als Engels (schriftelijk en mondeling).
Sterk analytisch vermogen en oog voor detail.
Communicatief vaardig en interpersoonlijk sterk.
Organisatorisch sterk, gestructureerd en accuraat in uitvoering.
In staat om strategisch en geduldig te werk te gaan bij complexe site-brede projecten.
Je weet een goede balans te vinden tussen compliance en efficiëntie.
Klantgerichte instelling met de motivatie om processen te optimaliseren in functie van de gebruikersnoden.
Ervaring of uitgesproken interesse in projectmatig werk binnen een productieomgeving.
Ons aanbod? Wij bieden je een contract van onbepaalde duur en een aantrekkelijk salarispakket. Je krijgt bovendien de kans om zich zowel persoonlijk als professioneel te ontwikkelen via interne opleidingen. Geïnteresseerd? Wacht dan niet langer en stuur je CV naar [email protected]
