You will operate within a GMP analytical and MSAT environment as a senior Subject Matter Expert, leading analytical validation and qualification activities across MSAT, PAD, and QC laboratories .Your focus will be on defining and overseeing analytical validation strategies, ensuring methods are GMP-compliant, fit for purpose, and successfully transferred. You will also act as a technical advisor, coaching internal teams and engaging directly with clients and auditors.
Key ResponsibilitiesDefine and govern analytical validation and qualification strategiesEnsure lifecycle-compliant method validation (ICH Q2)Author, review, and approve GMP protocols and reportsLead and support analytical method transfers (client to QC/PAD and internal)Manage deviations, OOS, and invalid resultsProvide SME-level technical decision-making and data reviewSupport client interactions, inspections, and audits
Essential RequirementsMSc or PhD in Analytical Chemistry, Biochemistry, Biotechnology, or related disciplineMinimum 5 years' senior experience in analytical validation / qualificationStrong knowledge of EU GMP and FDA regulationsProven expertise in GMP analytical validation and lifecycle approachesHands-on experience with method transfer activitiesAbility to work independently at an advisory / SME levelExcellent scientific writing and communication skillsFluency in English (spoken and written)
Preferred ExperienceExposure to ATMP, cell therapy, or gene therapy environmentsExperience with:Total Error and statistical validation approachesBridging strategies for reagents and reference standardsAnalytical Quality by Design (aQbD)Client-facing experience, including release and IPC strategy definitionParticipation in regulatory inspections and client auditsProfessional working proficiency in FrenchExperience mentoring or coaching analytical or MSAT teams
Practical DetailsStart date: ASAPContract length: 3 months (extension highly likely)Location: Liège, Belgium (hybrid – approx. 3 days on-site per week)
Interested?The interview process is moving quickly.Submit your CV to m.vansloun@panda-int.com or call +32 460 25 75 29 to secure your place.
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