Biopharma Method Development Scientist (qPCR/ELISA)

MindCapture BV; Geel; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Meal vouchers

Eco vouchers

Health insurance

Group insurance

Net expense allowance

Company car with charging or fuel card

Job summary

MindCapture is recruiting an Analytical Method Development Scientist for its Geel site. You will develop, optimise and validate analytical methods supporting mammalian cell culture and biological therapeutics, transferring methods across development, manufacturing and quality control.

Working in a collaborative environment, you will design experiments (DOE), interpret data, document results and ensure regulatory compliance, while contributing to patient safety and product quality onsite in Geel.

Qualifications

• PhD in Life Sciences, Biochemistry, Biotechnology or equivalent.
• Strong hands-on experience with qPCR and ELISA for host cell impurity analysis.
• Proven ability to develop, qualify and validate analytical methods in biopharma.
• Experience with regulatory expectations and cGMP compliance.
• DOE studies for analytical method qualification and validation.
• Excellent technical writing and documentation skills.
• Ability to work independently and manage multiple priorities.
• Knowledge of protein characterisation techniques a plus.
• Fluent English; Dutch language knowledge desirable; onsite in Geel.

Responsibilities

• Act as SME in qPCR and ELISA for host cell impurity analysis.
• Design, develop, qualify and validate analytical methods for biopharma processes.
• Coordinate method handovers from R&D to manufacturing support functions.
• Support Quality Control with transfer protocols and reports.
• Independently design and execute analytical studies including DOE.
• Perform data trending and statistical evaluations of method performance.
• Investigate deviations and propose scientifically justified corrective actions.
• Prepare analytical protocols, validation docs and technical reports.
• Support laboratory testing and implement methods on site in Geel.
• Communicate findings and collaborate with multidisciplinary teams.

Skills

qPCR/ELISA

Analytical method development

Regulatory knowledge (cGMP)

Design of Experiments

Statistical data analysis

Scientific documentation

Independent working

Protein characterisation (SDS-PAGE/WB)

English & Dutch communication

Education

PhD in Life Sciences/Biochemistry/Biotechnology

Job description

MindCapture is recruiting an Analytical Method Development Scientist for its Geel site. You will develop, optimise and validate analytical methods supporting mammalian cell culture and biological therapeutics, transferring methods across development, manufacturing and quality control.

Working in a collaborative environment, you will design experiments (DOE), interpret data, document results and ensure regulatory compliance, while contributing to patient safety and product quality onsite in Geel.