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 Responsibilities
Define and govern analytical validation and qualification strategies
Ensure lifecycle-compliant method validation (ICH Q2)
Author, review, and approve GMP protocols and reports
Lead and support analytical method transfers (client to QC/PAD and internal)
Manage deviations, OOS, and invalid results
Provide SME-level technical decision-making and data review
Support client interactions, inspections, and audits
Essential Requirements
MSc or PhD in Analytical Chemistry, Biochemistry, Biotechnology, or related discipline
Minimum 5 years’ senior experience in analytical validation / qualification
Strong knowledge of EU GMP and FDA regulations
Proven expertise in GMP analytical validation and lifecycle approaches
Hands-on experience with method transfer activities
Ability to work independently at an advisory / SME level
Excellent scientific writing and communication skills
Fluency in English (spoken and written)
Preferred Experience
Exposure to ATMP, cell therapy, or gene therapy environments
Experience with:
Total Error and statistical validation approaches
Bridging strategies for reagents and reference standards
Analytical Quality by Design (aQbD)
Client-facing experience, including release and IPC strategy definition
Participation in regulatory inspections and client audits
Professional working proficiency in French
Experience mentoring or coaching analytical or MSAT teams
Practical Details
Start date:
ASAP
Contract 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.
demandeur d emploi
recruteur