Labcorp is seeking a Senior Quality Control Scientist to join our new CMC facility in Mechelen, Belgium.
**Job Responsibilities: **
Project Leadership and client interaction
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Lead scientific discussions with clients as from initiation and serve as the primary technical contact for assigned molecules or projects.
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Demonstrate oversight of the drug development process and the ability to advise the client on the project design.
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Define project scope, contribute to proposals in conjunction with client, proposal management and the PMO
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Support client meetings and audits.
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Hold an in-depth knowledge of regulatory expectations, and section specific techniques and capabilities, in order to advise the client or internal customer.
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Translate client needs into clear analytical strategies and timelines.
Study Design and Planning
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Review and assess client methods, perform gap analyses, and design both standard and complex protocols.
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Rapidly onboard new client projects and ensure all safety (including GMO risk assessments) and regulatory requirements are in place.
Execution and technical oversight
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Attend client conference calls and meetings for specific technical requirements within area of expertise and act as primary technical client contact when acting as molecule lead.
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Prepare and approve project protocols and amendments. Ensure that the required regulatory, scientific and client requirements are captured.
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Prepare, review, and approve protocols for all assay types (development, validation, sample analysis, release testing), reports, Certificates of Analysis (CofA), and assay documentation.
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Oversee assay execution, troubleshoot analytical challenges, and guide teams through unexpected scientific issues.
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Review and approve regulatory data, assay-based quality documents (Quality Events, risk assessments, CAPA鈥檚, change controls and Out of Specification) and investigation reports.
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Coordinate laboratory activities and ensure work aligns with SOPs, GMP, and client expectations.
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With understanding of all methodologies for a Client project you will formulate reports using approved data that fulfils the protocol design and all regulatory expectations.
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Perform laboratory work as required.
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Be accountable for QA and Client comments on protocols and reports where necessary.
Monitoring & Quality
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Track study progress, anticipate risks, and drive timely resolution of issues.
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Ensure adherence to quality agreements and regulatory standards.
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Lead in-depth scientific and/or quality discussion with the client and/or internal customer.
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Support client and regulatory audits as needed.
Scientific Expertise and team development
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Manage multiple batch testing, release testing, sample analysis, stability, assay development and validations/transfers studies.
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Act as a subject matter expert within QC and across CMC workstreams.
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Mentor and support colleagues, contribute to training materials, and help strengthen scientific capability across the team.
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Represent Labcorp at conferences, client meetings, and scientific forums.
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Navigate the regulatory framework to ensure that the client programs are conducted with scientific integrity, to meet the defined milestones along the drug development pathway.
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Identification and communication of scientific and regulatory developments to QC operations and the wider senior scientific group (e.g. Method Development/Clients).
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Maintain in-depth knowledge of relevant scientific and GMP guidelines and knowledge of the relevant area of the drug development process.
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Maintain in-depth knowledge of regulatory expectations and multiple method capabilities. Be aware of current client / industry expectations.
Minimum Qualifications:
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BSc (Hons) scientific degree.
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6 or more years of experience in Quality Control
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3 years of experience in CMC Drug Development working to GMP regulations.
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Knowledge and application of GMP guidelines and regulatory guidelines in a QC environment
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5 or more years experience in CMC analytical techniques (e.g. HPLC, compendial technique, **Capillary Electrophoresis (CE), Osmolality, Karl Fisher Moisture, Turbidity, Particulates, UV , iCE, pH, appearance). **
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Fluent knowledge of English and Dutch
Preferred Qualifications:
- 1 or more years experience in client stability programs and batch release experience
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Additional Job Standards:
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3 or more years experience in **study management **or similar activities.
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1 or more years of experience in **client management and stakeholder management **
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Managing and completing** quality documentation.**
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Process excellence processes, tools and activities.
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Computing skills, including word processing and use of spreadsheets (e.g. Microsoft Office packages).
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Experience and knowledge of **statistics and application to techniques and regulatory applications (validation, equivalence).聽**
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Excellent verbal and communication skills with ability to communicate effectively at all levels.
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Knowledge and practice of general health & safety, including personal protective equipment.
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Knowledge and experience of** scientific software packages**
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Commercial awareness, interpersonal and negotiating skills.
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Hosting clients and occasional travel outside of normal working hours for client visits, conferences or to other Labcorp sites may be required.
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Overtime as required, including weekend, as per company policy.
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Risk of exposure to potentially hazardous substances, e.g during laboratory activities.
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Mandatory immunizations and screening as required.
Labcorp is expanding its global BioPharmaceutical Chemistry, Manufacturing and Control (CMC) footprint and is opening a new CMC facility in Mechelen, Belgium.
Biopharmaceutical CMC provides independent, objective GMP analytical testing for manufactured medicinal products from late discovery through post-market approval on behalf of global clients.聽 With a strong portfolio of clients and over 25 years of expertise the BioCMC team provides advanced characterization, method development, stability and routine QC release for biologics, vaccines, ATMP鈥檚, and a breadth of other complex biomolecules.聽
With this new laboratory in Belgium, we aim to offer a more comprehensive solution and accelerate the availability of new products for patients. The new site has been strategically developed to complement our existing capabilities in York and Harrogate (UK), and Greenfield (US) and introduce a new CMC analytical testing solution for commercial drug products in the European Union (EU).
This expansion is a key milestone in our long-term plan to strengthen support for pharmaceutical and biotechnology partners who rely on Labcorp for complex CMC and regulatory testing services. If you would like to join us and be a part of this exciting journey, take a look at the fantastic opportunities we have to offer.
Labcorp is looking for an experienced and driven **Senior QC Scientist **to join our new CMC facility in Mechelen. 聽
In this role, you鈥檒l take ownership of complex analytical projects, act as a scientific subject matter expert, and work directly with clients to shape high鈥慽mpact drug development programs.
Working as part of BioCMC Operations, the QC Scientist manages a range of small to large multi-technique projects as a molecule lead, providing internal and external clients with a central scientific point of contact for projects.
During the first months, you will support with the setup of the lab, initiation of the equipment, documentation and ensure overall lab onboarding readiness. You will run test assays for audit readiness and help with initiation and setup of regulatory part.
This position is an onsite role.
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.聽
We encourage all to apply
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