Expert Solid State & Non-Chromatographic Analytical Technologies Scientist M/V/X

Beschrijving van de functie

Antwerp - contracting
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.

Jouw profiel

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.

Taalvaardigheden

• Nederlands (troef)

  • Begrijpen : Vaardig - (C1)
  • Schrijven : Vaardig - (C1)
  • Lezen : Vaardig - (C1)
  • Spreken : Vaardig - (C1)

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