Analytical Scientist - Method Validation & Transfer

Pauwels Consulting; Geel; On-site; EUR 85,000 - 115,000; Full time

Job summary

Pauwels Consulting is seeking an Analytical Scientist to join a leading biopharmaceutical client’s manufacturing science and technology division. You will manage the transfer and validation of analytical methods to support the production of innovative biologics within a global manufacturing network.

Key duties include leading method transfer and validation for biologics, designing and executing analytical studies, performing root-cause investigations, and authoring SOPs and technical reports

Qualifications

• PhD in Life Sciences, Biochemistry, Biotechnology, or equivalent.
• Proven experience in analytical qualification and validation for biologics (monoclonal antibodies, recombinant proteins, or vaccines).
• Hands-on expertise with ELISA, protein binding interaction methods, and spectroscopy.
• In-depth knowledge of cGMP, ICH guidelines, and USP/Ph. Eur. monographs.
• Analytical problem-solving with ability to manage multiple projects and translate requirements into DOE experiments.
• Fluent English with active knowledge of Dutch.

Responsibilities

• Lead analytical method transfer and validation projects for biologics production processes per ICH Q2(R2) and pharmacopoeial requirements.
• Design and execute comprehensive analytical studies and perform root cause investigations for analytical deviations.
• Develop technical expertise to serve as a subject matter expert for assigned analytical methods and instrumentation.
• Author SOPs, protocols, and technical reports while ensuring data integrity and cGMP compliance.
• Perform hands-on laboratory testing using ELISA, protein binding methods, and spectroscopy.
• Execute DOE experiments and apply statistical analysis to monitor method performance.
• Collaborate cross-functionally with research and quality control teams and present findings in project meetings.

Skills

Analytical problem-solving

Project management

DOE (Design of Experiments)

Statistical analysis

Fluent English

Dutch (active knowledge)

Education

PhD in Life Sciences / Biochemistry / Biotechnology

Tools

ELISA

Protein binding methods

Spectroscopy

DOE software

Job description

Our client, a leading biopharmaceutical organization, is seeking an Analytical Scientist to join their manufacturing science and technology division. The role involves managing the transfer and validation of critical analytical methods to support the production of innovative biologics within a global manufacturing network.

• Lead analytical method transfer and validation projects for biologics production processes in compliance with ICH Q2(R2) and pharmacopoeial requirements.
• Design and execute comprehensive analytical studies and perform root cause investigations for analytical deviations.
• Develop technical expertise to serve as a subject matter expert for assigned analytical methods and instrumentation.
• Author Standard Operating Procedures (SOPs), scientific protocols, and technical reports while ensuring strict adherence to cGMP and data integrity standards.
• Perform hands-on laboratory testing using techniques such as ELISA, electrophoresis, receptor binding assays, and qPCR.
• Execute Design of Experiments (DOE) and perform statistical analysis to monitor method performance and reliability.
• Collaborate cross-functionally with research and quality control teams to provide technical updates and present findings in project meetings.

• You have a PhD in Life Sciences, Biochemistry, Biotechnology, or equivalent through experience.
• You bring proven experience in analytical qualification and validation for biologics including monoclonal antibodies, recombinant proteins, or vaccines.
• You possess hands-on expertise with ELISA, protein binding interaction methods, and spectroscopy.
• You have a deep understanding of cGMP requirements, ICH Q guidelines, and USP/Ph. Eur. monographs.
• You're an analytical problem-solver capable of managing multiple projects and translating technical requirements into DOE experiments.
• You are fluent in English with active knowledge of Dutch.

Nice to Haves

• Experience with automated liquid handlers such as Tecan, Hamilton, or Andrew.
• Knowledge of protein characterization techniques including CD, DLS, AUC, or Western blot.
• Willingness to adopt AI-driven technologies and digital laboratory workflows.