QC Senior Engineer | Analytical Methods Validation & Transfer | Biopharma GMP | Basel

Recrutis is supporting one of its clients, a leading biopharmaceutical company in the Basel area, in the search for a QC Senior Engineer dedicated to analytical methods validation and transfer activities supporting a regulatory submission and remediation programme.

This is a hands-on QC analytical role focused on the validation and transfer of HPLC-based methods, enzymatic activity assays, size exclusion chromatography (SEC) and kinetic enzyme assays. This is not a generalist QC role, not a routine release-testing role, and not a pure Analytical Development role — it is a method lifecycle role at the QC / AD interface.

Why this role

• High-visibility role directly linked to a regulatory submission and remediation programme
• Full ownership of analytical methods validation and transfer scope across multiple techniques
• Hands-on technical exposure: HPLC, enzymatic activity assays, SEC, kinetic enzyme assays
• 3–6 month consulting mission with strong visibility and immediate technical impact
• High-standard biopharma GMP environment in the Basel area

Key information

• Location: Basel area, Switzerland — primarily on-site (100%)
• Contract: Consulting mission (3–6 months)
• Start: ASAP
• Seniority: 5+ years in QC analytical methods validation & transfer (pharma / biotech)
• Languages: English B2/C1 mandatory

Scope

• Plan, execute and document analytical methods validation studies in line with ICH Q2(R1) and ICH Q14
• Lead analytical method transfer activities between sites and / or between functions (AD QC)
• Author validation and transfer protocols, reports and gap analyses to support the submission file
• Support remediation activities and CAPA implementation linked to analytical methods lifecycle
• Investigate OOS, OOT and method deviations encountered during validation and transfer
• Collaborate cross-functionally with QC operations, Analytical Development, QA and Regulatory Affairs
• Ensure compliance with EU GMP, ICH Q2(R1), ICH Q14, USP General Chapters and FDA expectations
• Contribute to the technical defence of methods during inspections and audits

Profile — knockout criteria

Applications not meeting all knockout criteria below will not be reviewed.

• 5+ years of hands-on QC experience in pharma or biotech — methods validation & transfer focus
• Direct expertise in HPLC method validation (specificity, linearity, accuracy, precision, robustness, system suitability)
• Practical experience with enzymatic activity assays, kinetic enzyme assays and size exclusion chromatography (SEC)
• Primary author on validation protocols and reports — not reviewer / approver only
• Strong working knowledge of EU GMP and ICH Q2(R1) — applied on validation projects, not purely documentary
• English B2/C1 mandatory (working language)

Nice to have

• Master's or PhD in Chemistry, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or equivalent
• Direct experience supporting a regulatory submission file (BLA, MAA) or a remediation programme
• Familiarity with ICH Q14 (analytical procedure development)
• Experience with biologics characterization techniques beyond SEC and enzymatic assays
• Cross-functional exposure to Analytical Development and / or Tech Transfer

Keywords

QC, Quality Control, Analytical Methods Validation, Method Transfer, HPLC, SEC, Size Exclusion Chromatography, Enzymatic Activity Assay, Kinetic Enzyme Assay, ICH Q2, ICH Q14, EU GMP, FDA, Regulatory Submission, Remediation, OOS, OOT, CAPA, Biopharma, Biotech, Pharma Manufacturing, Switzerland, Schweiz, Basel, Bâle.

Process — Confidential recruitment process. Response within 48 hours for applications meeting the knockout criteria. Active mandate, priority review.

Fabrice Cattant — Founder, Recrutis | Expert & Executive Search in Life Sciences