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.