Process Development Scientist – Biotech, DoE & PPQ

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

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.