Process Development Scientist

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. Apply now and let’s make an impact together Want to learn more? Discover all opportunities at www.mindcapture.com. 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.