Biologics Method Validation Scientist - High-Impact GMP Role

MindCapture BV; Belgique; Remote; EUR 75,000 - 115,000; Full time

Benefits offered by this job

Meal vouchers

Eco vouchers

Health insurance

Group insurance

Net expense allowance

Company car with charging or fuel card

Job summary

MindCapture BV in Belgium seeks an Analytical Method Validation Scientist to own transfer and validation projects for biologics, blending hands-on lab work with rigorous analysis.

Define strategies, execute studies on content, potency and impurities, troubleshoot deviations and document procedures to ensure GMP compliance. The role is on site with our client, offering onboarding and ongoing development in a collaborative, impact-driven environment.

Qualifications

• PhD in life sciences, biochemistry, biotechnology or equivalent expertise.
• Proven experience with analytical qualification or validation for biologics.
• Strong practical expertise with immunoassays, protein binding methods and spectroscopy.
• Strong understanding of relevant international guidelines and pharmacopoeial requirements.
• Excellent knowledge of GMP requirements for analytical testing.
• Experience with advanced protein characterisation techniques is a plus.
• Experience with automated liquid handling technologies is a plus.
• Statistics: ability to perform statistical analysis and interpret analytical method performance.
• Experimental design: experience designing and interpreting experiments for analytical qualification and validation.
• Strong technical writing skills with fluent written and spoken English.

Responsibilities

• Define and execute validation strategies for analytical methods supporting biologics.
• Lead analytical method transfers across manufacturing and laboratory environments.
• Design and execute studies covering content, potency and impurity testing.
• Investigate analytical deviations and resolve method performance issues.
• Perform statistical analysis, trending and ongoing method performance monitoring.
• Write analytical procedures, study protocols and technical reports.
• Ensure laboratory activities and documentation meet data integrity and GMP requirements.
• Develop subject matter expertise for assigned methods, instrumentation and products.
• Perform analytical testing using immunoassays, binding assays, molecular techniques and spectroscopy.
• Collaborate with research, manufacturing science, external laboratories and Quality Control teams.

Skills

Immunoassays

Protein binding methods

Spectroscopy

Statistical analysis

Experimental design

Technical writing

English communication

Education

PhD in life sciences, biochemistry, biotechnology or equivalent expertise

Tools

Automated liquid handling

Job description

MindCapture BV in Belgium seeks an Analytical Method Validation Scientist to own transfer and validation projects for biologics, blending hands-on lab work with rigorous analysis.

Define strategies, execute studies on content, potency and impurities, troubleshoot deviations and document procedures to ensure GMP compliance. The role is on site with our client, offering onboarding and ongoing development in a collaborative, impact-driven environment.