Analytical Scientist: Biologics Transfer & Validation

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

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