Process Development and Manufacturing Technology Scientist

Jobs / Process Development and Manufacturing Technology Scientist

Process Development and Manufacturing Technology Scientist

At MindCapture you are not just starting a new role. You are joining a community that invests in your development and gives you the opportunity to grow in a meaningful technical career within healthcare.

You can count on:

• A competitive salary with a full benefits package including meal vouchers, eco vouchers, health insurance, group insurance, net expense allowance and a company car with charging or fuel card
• Personal growth support with tailored training and clear career development
• A stable environment where your technical skills directly contribute to improved patient care
• The chance to work with high tech diagnostic systems at top tier healthcare institutions
• A warm and collaborative culture focused on trust, ownership and long term impact

Our client, an innovative biotechnology organisation based in Ghent, is looking for a Process Development and Manufacturing Technology Scientist to support the development, optimisation and validation of biological manufacturing processes.

The organisation focuses on process and analytical development for biological products, including vaccines and other biotherapeutics. Its activities cover fermentation, downstream processing, formulation, lyophilisation and GMP manufacturing support. In this role, you will contribute to advanced process development activities, supporting the transition from laboratory studies to large scale manufacturing. You will play a key role in process characterisation, Process Performance Qualification (PPQ) preparation and process validation while providing technical expertise to external manufacturing partners. This position combines practical laboratory activities, scientific data analysis and technical documentation within a collaborative and quality focused environment.

Key responsibilities

• Process Characterisation: Design and execute process characterisation studies to establish Normal Operating Ranges (NOR) and Proven Acceptable Ranges (PAR), supporting Process Performance Qualification activities.
• Experimental Design: Apply Design of Experiments (DoE) principles to develop scientifically sound studies and support data driven process optimisation.
• Laboratory Process Development: Perform practical laboratory activities involving cultivation, fermentation and lyophilisation to generate data supporting advanced process development.
• Data Analysis and Process Trending: Analyse fermentation and lyophilisation data, monitor process trends and evaluate process performance to identify potential improvements.
• Technical Documentation: Prepare development protocols, study reports and technical procedures while reviewing internal development studies and associated documentation.
• Technology Transfer and Manufacturing Support: Review technical transfer documentation, manufacturing batch records and external reports while providing technical support to manufacturing partners, including on site assistance when required.
• Process Investigations: Investigate process deviations, unexpected trends and results outside established specifications to identify potential root causes and recommend corrective actions.
• Risk Assessment: Conduct process risk assessments using structured methodologies such as Failure Mode and Effects Analysis (FMEA) to support robust process development.
• Scientific Communication: Present technical findings, study results and process performance data to internal stakeholders and external manufacturing partners.
• Laboratory and Quality Support: Contribute to general laboratory activities, maintain relevant departmental documentation and collaborate with colleagues to ensure compliance with applicable quality standards.

Required competences & skills

• Educational Background: Master’s degree in Biochemistry, Biotechnology or a related scientific discipline.
• Professional Experience: At least 5 years of professional experience, including 2 to 3 years in pharmaceutical process development and process validation supporting preparation for a biological licence application.
• Bioprocess Expertise: Strong knowledge of fermentation and lyophilisation processes, including their application in biological product development.
• Laboratory Experience: Several years of practical laboratory experience involving biological process development and experimental studies.
• Regulatory Knowledge: Knowledge of cGMP regulations and ICH guidelines, particularly ICH Q8 relating to pharmaceutical development.
• Experimental Design: Experience applying Design of Experiments methodologies to process characterisation studies is a plus.