Senior Bioprocess Development Scientist - Manufacturing

MindCapture BV; Oost-Vlaanderen; Sur place; EUR 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Eco vouchers

Health insurance

Group insurance

Net expense allowance

Company car with charging or fuel card

Résumé du poste

MindCapture BV, Ghent-based biotech consultancy, seeks a Process Development and Manufacturing Technology Scientist to support advanced development, validation and transfer of biological manufacturing processes. You will contribute to NOR/PAR, DoE-based studies and technical documentation while collaborating with external partners.

The role blends lab work, data analysis and regulatory awareness in a quality-focused environment, with on-site client support and growth opportunities within

Qualifications

• Master’s degree in Biochemistry, Biotechnology or a related scientific discipline.
• Minimum 5 years professional experience, incl. 2–3 years in pharmaceutical process development and process validation.
• Strong knowledge of fermentation and lyophilisation.
• Fluency in English (written and spoken).
• Knowledge of cGMP and ICH guidelines.
• Experience applying Design of Experiments to characterisation studies.

Responsabilités

• Design and execute process characterisation studies to establish NOR and PAR.
• Apply Design of Experiments principles to develop scientifically sound studies and support data-driven process optimisation.
• Laboratory activities involving cultivation, fermentation and lyophilisation to generate development data.
• Analyse fermentation and lyophilisation data; monitor trends and evaluate process performance.
• Prepare development protocols, study reports and technical procedures; review internal documentation.
• Support technology transfer and manufacturing with documentation and on-site support.
• Investigate process deviations, identify root causes and recommend corrective actions.
• Perform risk assessments using FMEA to support robust process development.
• Present findings to internal stakeholders and external manufacturing partners.
• Maintain laboratory and quality documentation to ensure compliance.

Connaissances

Bioprocess expertise

Experimental design

Statistical analysis

Communication skills

Regulatory knowledge

GMP and quality systems

Professional competencies

Formation

Master’s degree in Biochemistry/ Biotech or related science

Description du poste

MindCapture BV, Ghent-based biotech consultancy, seeks a Process Development and Manufacturing Technology Scientist to support advanced development, validation and transfer of biological manufacturing processes. You will contribute to NOR/PAR, DoE-based studies and technical documentation while collaborating with external partners.

The role blends lab work, data analysis and regulatory awareness in a quality-focused environment, with on-site client support and growth opportunities within