Method Development & Validation Specialist

Method Development & Validation Specialist

Eurofins

Braine l'Alleud, Belgium

Job Description

• Collect information required for the analytical target profile from Project (analytical lead, project manager, product owner…);
• Propose and test candidate analytical techniques potentially able to meet expected needs;
• Develop robust & efficient analytical methods by aQBD using classical LC-UV method with no/limited assistance utilizing modern & state‑of‑the‑art statistical approaches to bring them to successful validation;
• Collect data from development and take decisions/propose solutions based on obtained results. Prepare support and present development status in technical team review meetings;
• Assure that complex technical data are reported with scientific excellence and communicate the outcome of the analytical activity to team/supervisor/customer;
• Understand and master all regulatory requirements pertaining to analytical method performance;
• Contribute and/or collaborate to analytical method validation/co-validation/transfer both internally or external labs;
• Design complex study designs and write associated Quality documents (protocols, reports, procedures);
• Document results in laboratory notebooks according to established GDP procedures;
• Advise supervision and customer when facing issues and propose options to meet timeline/define new timeline;
• Participate in method comparability/equivalence studies to enable continuation of the analytical method lifecycle;
• Interact with cross‑functional teams of analytical experts with internal/external labs/suppliers;
• Identify risks, issues and opportunities and communicate to supervisor and customer;
• Collaborate to investigations in complex analytical issues corresponding to atypical or out‑of‑specification/trend test results and instrumentation/methodology issues.

Qualifications

• Holds a master’s degree in chemistry/Analytical chemistry or a similar field;
• We are looking for candidates who have more than 4 years of experience;
• Strong technical knowledge of various analytical techniques, especially Liquid Chromatography (LC-UV) with significant experience in development validation/verification/transfer and troubleshooting;
• Understanding of interactions with other disciplines: Formulation, Process Development, Regulatory Affairs, QA;
• Strong knowledge of compendial and other applicable regulations;
• Fluent communication skills in English; French is nice to have;
• Basic project management skills;
• The candidate must show Ownership, critical mindset and out of the box thinking;
• Ability to operate in certified environments;
• Eagerness to learn new analytical techniques;
• Knowledge of new analytical strategies (ICH Q14, QbD…).