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QC scientist HPLC Compendial techniques
Functieomschrijving
Labcorp is seeking a Senior Quality Control Scientist to join our new CMC facility in Mechelen, Belgium.
This position is an onsite role.
Job Responsibilities:
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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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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. 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.
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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’s, 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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Track study progress, anticipate risks, and drive timely resolution of issues.
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Lead in-depth scientific and/or quality discussion with the client and/or internal customer.
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Manage multiple batch testing, release testing, sample analysis, stability, assay development and validations/transfers studies.
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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.
Profiel
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:
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1 or more years experience in client stability programs and batch release experience
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).
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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.
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