Scientist - Pharmacopeia Solutions (m/w/d)
📋 Détails de l'offre
As Scientist for the current position, you will act as the key liaison between the laboratory team and the Analytical Manager, ensuring seamless communication and technical alignment across all analytical operations. Your function will involve both administrative tasks as well as experimental, analytical lab work as described in detail under responsibilities.
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Method Development & Validation
: Independently plan and execute method development and validation projects, including the preparation and approval of all required GMP documentation (SOPs, protocols, and reports).
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Analytical Execution
: Perform and oversee analyses in classical CHNSO combustion and TOC analytics (including TNb, swab extraction and cleanability studies) within the framework of cleaning validations, as well as titration and potentiometric techniques (e.g., Karl Fischer, Argentometry, ISE).
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Operational Support
: Provide hands-on assistance and expert troubleshooting for daily laboratory operations, with a proactive approach to taking ownership of advanced analytical challenges and inquiries.
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Project & Quality Management
: Ensure the timely completion of projects, delivering high-quality results that meet or exceed client expectations through effective self-management and rigorous attention to detail.
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Compliance & Organisation
: Maintain meticulous, GMP-compliant documentation and archiving of all laboratory activities while assisting with organisational tasks to ensure smooth and efficient lab workflows.
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Instrument Stewardship
: Take charge of analytical instrumentation, ensuring data integrity, performing routine management/maintenance and coordinating with external suppliers as required.
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Degree in chemistry, pharmacy, biology or a related field in the natural sciences
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Proven hands-on experience in the analytical techniques mentioned above, including proficiency in relevant sample preparation methods.
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Prior experience handling quality related topics (quality events, changes, deviations, OOS) is considered a distinct advantage.
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Experience in quality events, change requests, deviations or out-of-specification process and documentation is advantageous
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Proactive with a can-do attitude and very good communication skills and scientific writing skills
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Advanced skills in MS Office (Word, Excel, PowerPoint) and basic experience with LIMS (e.g., LabWare) are considered a plus
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Professional experience within a GMP-regulated environment is highly desirable.
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Dedicated team player with a strong service-oriented mindset and a high sense of responsibility.
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Fluency in English (both written and spoken) is required; knowledge of German is a beneficial asset.
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🏢 À propos de l'entreprise
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