Process Development Scientist

MindCapture BV; Oost-Vlaanderen; On-site; EUR 65,000 - 95,000; Full time

Benefits offered by this job

Meal vouchers

Eco vouchers

DKV health insurance

Group insurance

Net expense allowance

Company car

Job summary

MindCapture BV seeks a Process Development and Manufacturing Technology Scientist to support innovative biological product development. The role combines lab work with data analysis and manufacturing support for large-scale activities, including NOR/PAR and PPQ.

You design characterization studies, apply DoE, perform fermentation and lyophilisation, analyze data, and prepare reports while collaborating with internal teams and external partners.

Qualifications

• Master's degree in Biochemistry, Biotechnology or related field.
• 5+ years professional experience including 2–3 years in pharmaceutical process development and process validation for biological licence preparation.
• Strong knowledge of fermentation and lyophilisation processes.
• Several years of practical laboratory experience.
• Familiar with cGMP regulations and ICH guidelines, especially ICH Q8.
• DoE experience for process characterisation is an advantage.
• Experience with statistical data analysis software is an advantage.
• GMP laboratory or manufacturing experience is an advantage.
• Familiarity with quality management systems is an advantage.
• Proactive, independent working style with strong organisational skills and good communication.

Responsibilities

• Design process characterisation studies to establish NOR and PAR for PPQ activities.
• Apply DoE principles to support process development and optimisation.
• Perform lab activities involving cultivation, fermentation and lyophilisation.
• Analyse fermentation and lyophilisation data to evaluate process performance.
• Initiate, monitor and analyse process trending activities.
• Prepare development protocols, study reports and technical documentation.
• Review internal development studies, technology transfer docs and batch records.
• Provide technical support for large-scale manufacturing with external partners, including on-site assistance.
• Investigate process deviations and trends outside specifications.
• Conduct process risk assessments using FMEA.
• Present data and findings to stakeholders.
• Support general laboratory activities and maintain procedures.

Skills

DoE methods

Fermentation know-how

Lyophilisation expertise

Statistical analysis

GMP lab experience

Technical reporting

English fluency

Education

Master's degree in Biochemistry/Biotech

Job description

We are looking for a Process Development and Manufacturing Technology Scientist to support innovative biological product development within a dynamic biotechnology environment.

In this role, you will contribute to process characterisation, Process Performance Qualification (PPQ) preparation and process validation. You will combine practical laboratory work with scientific data analysis and technical support for large scale manufacturing activities.

What's offered?

Ready to grow your career and make real impact? Join MindCapture!

We offer competitive salaries, a full benefits package (meal vouchers, eco vouchers, DKV health insurance, group insurance, net expense allowance, and a company car). You also get the opportunity to shape your future through personalised training and development.

At MindCapture, you choose what you love, build on your strengths, and make a difference where it matters most.

You will work as a MindCapture consultant for an international start up in the biotechnology industry.

Job Description:

• Design process characterisation studies to establish Normal Operating Ranges (NOR) and Proven Acceptable Ranges (PAR), supporting PPQ activities.
• Apply Design of Experiments (DoE) principles to support process development and optimisation.
• Perform practical laboratory activities involving cultivation, fermentation and lyophilisation.
• Analyse fermentation and lyophilisation data to evaluate process performance and identify improvement opportunities.
• Initiate, monitor and analyse process trending activities.
• Prepare development protocols, study reports and technical documentation.
• Review internal development studies, technology transfer documentation and manufacturing batch records.
• Provide technical support for large scale manufacturing processes at external manufacturing partners, including on site assistance when required.
• Investigate process deviations and results outside established trends or specifications.
• Conduct process risk assessments using methodologies such as Failure Mode and Effects Analysis (FMEA).
• Present scientific data and technical findings to internal and external stakeholders.
• Support general laboratory activities and maintain departmental procedures.

Requirements:

• Master’s degree in Biochemistry, Biotechnology or a related scientific discipline.
• 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.
• Strong knowledge of fermentation and lyophilisation processes.
• Several years of practical laboratory experience.
• Knowledge of cGMP regulations and ICH guidelines, particularly ICH Q8.
• Experience applying Design of Experiments (DoE) for process characterisation is a strong advantage.
• Experience with statistical data analysis software is an advantage.
• Experience working in a GMP laboratory or manufacturing facility is an advantage.
• Familiarity with established quality management systems is an advantage.
• Proactive and independent working style with strong organisational skills.
• Excellent communication, scientific reporting and presentation skills.
• Fluency in written and spoken English.
• Critical, accurate and pragmatic approach to problem solving.

Are you ready to make a real difference in healthcare?

Join our dynamic team and help drive innovation in medical devices.

If MindCapture sees a potential fit, we’ll get in touch as soon as possible.

If you don’t hear from us within two weeks, it simply means that this particular position wasn’t the right match. In that case, we’ll gladly keep your profile in mind for future roles that could suit you better.