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.
Meewerken aan engineeringprojecten rond formulatie-equipment binnen een aseptische productieomgeving
Verantwoordelijk voor jouw deel van het project van specificatie en design tot validatie en opstart
Coördineren van planning, uitvoering en opvolging binnen timing, budget en scope
Samenwerken in multidisciplinaire teams en afstemmen met interne en externe stakeholders
Opvolgen van veiligheid, kwaliteit, compliance en kostenefficiëntie
Ondersteunen bij verificatie, kwalificatie, cleaning- en sterilisatievalidatie
Problemen gestructureerd analyseren en transparant oplossen
Flexibel schakelen tussen documentatie, werfopvolging, testing en suppliercontacten
Profiel:
Masterdiploma in een technische of wetenschappelijke richting, zoals industrieel, burgerlijk of bio-ingenieur
Ervaring in een farmaceutische en/of GMP-omgeving, bij voorkeur aseptisch, is een sterke plus
Ervaring met validatie en projectcoördinatie of aannemersbeheer is een plus
Sterke communicatieve en organisatorische vaardigheden
Goede kennis van Nederlands en Engels; kennis van Frans is een plus
Analytisch, punctueel en proactief
Zelfstandig, assertief en sterk in probleemoplossend denken
Teamspeler met grote interesse in technische, technologische en procesmatige aspecten, en flexibel in een veranderlijke projectomgeving
Wat kan je verwachten? Je komt terecht in een internationale en innovatieve werkomgeving waar veiligheid, kwaliteit en samenwerking centraal staan. Je ontvangt een competitief loonpakket en uitgebreide extralegale voordelen, met volop kansen om je technische kennis verder te ontwikkelen en bij te dragen aan uitdagende projecten.
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.
Solid State & Non-Chromatographic Analytical TechnologiesScientist
Antwerp – contracting Your responsibilities?
Act as SME for non-chromatographic analytical technologies and provide scientific oversight
Maintain daily contact with the supervisors of non-chromatographic release and IPC labs to ensure optimal support for testing laboratories.
Drive complex scientific / quality investigations in your field in a cross-functional team and facilitate related remediation plans (e.g., CAPA plan).
Liaise with relevant partner organizations, such as QA, chemical production, R&D, CMC RA and build a network of contacts to support troubleshooting.
Drive systematic changes in QC non-chromatographic area, create and assess change controls, facilitate implementation plan.
Independently prepare, finalize, and/or review GMP procedures applicable to non-chromatographic laboratories of the QC.
Develop fit-for-purpose standards and guidelines applicable to the QC analytical laboratory to achieve both scientific excellence and regulatory compliance in a commercial QC environment where New Product Introduction is in strategic focus.
Drive the local implementation of best practices in the non-chromatographic area by having fit-for-purpose guidelines in place and by creating classroom / hands-on training opportunities.
Ensure scientific coaching of laboratory staff on technical and scientific matters in your field.
Monitor local practices in the lab, challenge status quo and ensure continuous improvement in alignment with latest industry trends, regulatory expectations and global practices.
Participate in global and local working groups to facilitate the implementation of state-of-art methodologies in your field (e.g., PAT, RTRT).
Promote quality awareness and proper adherence to GMP.
Provide support regarding equipment deviations and coordinate with the equipment management group for supplier contacts.
Explore, evaluate, and introduce new equipment and new analytical technologies in your field to ensure the laboratory evolves with increasing quality requirements and standards, while maintaining personal scientific expertise.
Drive and represent the QC in analytical lifecycle management initiatives for the legacy portfolio.
Drive analytical method transfer activities for non-chromatographic methods to and from the QC laboratories.
Act as system owner for an extensive laboratory instrument park. As system owner, verify that all training requirements are met before granting users access to equipment.
Maintain GMP standards to ensure continuous compliance with current requirements.
Participate in global compendial vigilance & compliance process by review compendial updates for “General Chapters” of EP, USP, JP, ChP, IP, and BP and by facilitating their fit-for-purpose local implementation.
Ensure inspection readiness of non-chromatographic laboratories of the QC and act as spokesperson during authority inspections.
Your profile?
Master’s degree in Chemistry, Pharmaceutical Sciences, or related field (PhD preferred)
Minimum 5 years of experience in small molecule analytical CMC (R&D, MSaT, industrialization)
Experience in late-stage development and API industrialization
Experience across different phases of pharmaceutical development is a plus
Fluent in English & Dutch
Up-to-date knowledge of pharmaceutical product release, stability testing, analytical method validation, analytical method transfer and compendial method verification as per current regulatory standards.
In-depth understanding of cGMP principles and relevant regulatory guidelines in the analytical area, such as ICH Q1, Q2, Q3/A,C,D, Q7, Q14, M7 relevant USP and Ph. Eur. chapters.
In-depth understanding of QbD, Quality Risk Management and lifecycle management principles, and relevant regulatory framework, such as ICH Q8, Q9, Q10, Q11, Q12.
In-depth scientific familiarity with the typical non-chromatographic analytical technologies occurring in small-molecule API synthesis, such as solid-state techniques (e.g., particle size distribution by laser diffraction, XRPD), titrations (water determination by KF, potentiometric titrations), IR spectroscopy, UV spectroscopy, Raman, AAS, ICP-OES/MS.
Familiarity with chemometrics, multivariate experimentation and modelling.
Hands-on experience with PAT and RTRT is an advantage.
Understanding of the principles of risk-based small-molecule process control strategy development, specification management (ICH Q6) and impurity management (ICH Q3 group of guidelines, ICH M7, latest regulatory standpoint on nitrosamines).
Ability to work independently in a dynamic environment, handle multiple tasks, and collaborate effectively.
Strong interpersonal and teamwork skills.
Ability to work across organizational boundaries through influencing, negotiation and partnering. Negotiation, communication, and presentation skills across all levels of the organization are important.
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.
Meewerken aan engineeringprojecten rond formulatie-equipment binnen een aseptische productieomgeving
Verantwoordelijk voor jouw deel van het project van specificatie en design tot validatie en opstart
Coördineren van planning, uitvoering en opvolging binnen timing, budget en scope
Samenwerken in multidisciplinaire teams en afstemmen met interne en externe stakeholders
Opvolgen van veiligheid, kwaliteit, compliance en kostenefficiëntie
Ondersteunen bij verificatie, kwalificatie, cleaning- en sterilisatievalidatie
Problemen gestructureerd analyseren en transparant oplossen
Flexibel schakelen tussen documentatie, werfopvolging, testing en suppliercontacten
Profiel:
Masterdiploma in een technische of wetenschappelijke richting, zoals industrieel, burgerlijk of bio-ingenieur
Ervaring in een farmaceutische en/of GMP-omgeving, bij voorkeur aseptisch, is een sterke plus
Ervaring met validatie en projectcoördinatie of aannemersbeheer is een plus
Sterke communicatieve en organisatorische vaardigheden
Goede kennis van Nederlands en Engels; kennis van Frans is een plus
Analytisch, punctueel en proactief
Zelfstandig, assertief en sterk in probleemoplossend denken
Teamspeler met grote interesse in technische, technologische en procesmatige aspecten, en flexibel in een veranderlijke projectomgeving
Wat kan je verwachten? Je komt terecht in een internationale en innovatieve werkomgeving waar veiligheid, kwaliteit en samenwerking centraal staan. Je ontvangt een competitief loonpakket en uitgebreide extralegale voordelen, met volop kansen om je technische kennis verder te ontwikkelen en bij te dragen aan uitdagende projecten.
Location:Braine-l'Alleud, Région wallonne, Belgique
Job#27622
QA for QC process
Contracting – Brabant Wallon
Your responsibilities: GENERAL QA ROLE
Using a Risk Based Approach, ensure that PSQC Processes & Operations are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and Policies & Procedures
Drive quality leadership and provide technical expertise on compliance strategy.
Communicate processes requirements effectively across functional areas.
Promoting culture of quality, operational excellence and “SOSD” (See it, Own it, Solve it, Do it) attitude within Patient Supply Quality Control.
Deliver general cGMP training and effective coaching on QMS to relevant stakeholders.
Communicate compliance status and issues to appropriate organizational levels.
Support regulatory inspections/audits, providing dynamic assistance to SME’s.
PATIENT SUPPLY QUALITY CONTROL PROCESSES
Participate in the improvement of the PSQC processes
Ensure adequate coaching and training of relevant stakeholders on the PSQC processes
Oversee critical global activities to ensure analytical operations are conducted in accordance with Quality Standards and applicable national and/or international regulations and guidelines (EMEA, FDA, PIC/S, ICH)
Manage and follow-up of Deviations, OOS, Failure Investigations, Change Control, Qualification/Validation, Compliance Audit activities, Stability program, Lab Critical Materials, and documentation approval related to the PSQC Processes & Operations.
Implement and maintain adequate Quality & Compliance indicators and communicate results to appropriate levels of the organization
CONTINUOUS IMPROVEMENT
Identify, coordinate and support opportunities for improvement and operational excellence projects in response to business needs, technical changes, risks, audit observations and regulatory requirements.
Lead or co-lead internal quality spot checks/audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to cGMP.
Conduct or support Quality Reviews exercises (e.g. Management/Product Reviews, etc)
Identify, coordinate and support Continuous Improvement projects (LEAN, 6-Sigma, Green belt and others) with QC management to enhance quality KPI’s and product/process quality.
Your profile:
Strong knowledge and proven experience in Quality Control and applicable regulations
Proven understanding of QC processes: stability studies, material management, specification management.
Experience with Quality Management System and Internal/External Auditing
Ability to balance multiple priorities, projects, provide leadership and prioritization, and work with minimal supervision
Excellent team player attitude with excellent interpersonal relationships and communication skills
Fluent 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]
