Offre Emploi CDI Cmc Analytical Expert Pharmaceutical Industry Belgique - Recrutement par VIQI

Détail du poste

Our client is a leading international pharmaceutical group, recognized for its commitment to innovation and scientific excellence. As part of its small-molecule drug substance development and industrialization activities, we are looking for an experienced CMC Analytical Expert to reinforce their team. You will operate at the interface of analytical R&D, regulatory strategy and manufacturing scale-up, within a highly collaborative and science-driven environment.

Missions

In this role, you will be responsible for providing analytical CMC expertise across the development and industrialization lifecycle of small-molecule APIs. Your key responsibilities will include:

Driving analytical method development, validation, transfer and compendial verification in compliance with current regulatory standards.
Ensuring release and stability testing strategies are aligned with ICH guidelines and cGMP requirements.
Contributing to the definition and management of process control strategies, specifications (ICH Q6) and impurity control frameworks (ICH Q3, M7, nitrosamines).
Applying QbD principles and Quality Risk Management approaches throughout the product lifecycle (ICH Q8-Q12).
Supporting regulatory submissions and interactions with health authorities on analytical CMC topics.
Collaborating cross-functionally with process chemistry, quality, regulatory and manufacturing teams.
Leveraging advanced analytical technologies including solid-state characterization, spectroscopy and PAT tools to support process understanding and real-time release strategies (RTRT).

Le profil recherché

Master's degree in Chemistry, Pharmaceutical Sciences or a related scientific field is required.
Minimum 5 years of experience in the small-molecule CMC analytical area (analytical R&D, MSaT, industrialization).
Solid background in late-stage development and/or small-molecule API industrialization.
In-depth knowledge of cGMP principles and ICH guidelines: Q1, Q2, Q3/A,C,D, Q6, Q7, Q8, Q9, Q10, Q11, Q12, Q14, M7, and relevant USP/Ph. Eur. chapters.
Hands-on expertise with non-chromatographic analytical technologies: solid-state techniques (laser diffraction, XRPD), titrations (Karl Fischer, potentiometric), IR/UV/Raman spectroscopy, AAS, ICP-OES/MS.
Familiarity with chemometrics, multivariate modelling and PAT/RTRT approaches is a plus.
Autonomous, rigorous and able to manage multiple priorities in a dynamic environment.
Strong interpersonal and communication skills, with the ability to influence and collaborate across all organizational levels.
Full professional proficiency in English; understanding of Dutch is required.