Senior Analytical Validation & Q&V SME (MSAT / PAD / QC)
Liège, Belgium – 3-month contract (Hybrid, extension highly likely)
Job Description
You will join a GMP analytical and MSAT environment supporting biopharmaceutical and ATMP programs, acting as the senior Subject Matter Expert for analytical validation and qualification activities across MSAT, PAD, and QC laboratories.
The role focuses on defining and governing analytical validation strategy, ensuring analytical methods are fit for purpose, GMP-compliant, and successfully transferred, while coaching teams and interfacing directly with clients and auditors.
Essential Requirements
* MSc or PhD in Analytical Chemistry, Biochemistry, Biotechnology, or related life sciences
* 5+ years of senior experience in Analytical Validation / Qualification & Validation
Proven expertise in:
* Analytical method validation (ICH Q2 / lifecycle validation)
* Qualification & Validation strategy definition
* GMP documentation (protocols and reports)
Strong hands-on experience in:
* Method transfers (client → QC / PAD and internal transfers)
* Managing deviations, OOS, and invalid results
* Deep knowledge of:
* EU GMP and FDA guidelines
* cGMP analytical requirements in biopharma and/or ATMP environments
* Ability to work independently at advisory / SME level
* Excellent scientific writing, data review, and technical decision-making skills
* Fluent English (written and spoken)
Preferred Requirements
* Experience in ATMP, cell therapy, or gene therapy
* Strong background in:
* Total Error approach
* Bridging strategies for reagents and reference standards
* Statistical assessment of validation data
* Experience applying Analytical Quality by Design (aQbD)
* Client-facing experience, including:
* IPC and release testing strategy definition
* Participation in regulatory and client audits
* French language skills (professional working proficiency)
* Prior experience coaching or mentoring analytical / MSAT teams
Practicalities
* Start Date: ASAP (immediate availability preferred)
* Contract Duration: 3 months, extension highly likely
* Location: Liège, Belgium (hybrid – approx. 3 days/week on-site)
Interested?
Interviews and offers can move quickly.
Send your CV to k.vongeusau@panda-int.com or call +31202044502 today to secure your spot in the process.