• Location: MECHELEN
• Job #27640

Solid State & Non-Chromatographic Analytical Technologies Scientist

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.