msat ast analytical project lead.

Tasks:

• Lead the transfer and or co-validation of analytical methods in contract lab organizations (CLO) in close collaboration with internal experts on the analytical technologies.
• Act as primary contact for the CLO, gather information and data generated at the CLO’s and evaluate against available internal data for existing or new production processes.
• Plan the analytical project(s) in your responsibility, identify risks and report progress & risks to the analytical team and governance bodies.
• Maintain, adjust, and communicate documentation and knowledge.
• Write and review transfer/co-validation protocols and reports.
• Support dossier submission activities with regards to analytical aspects

Experience:

• Preferably PhD in Life Sciences or are equivalent through experience.
• Expertise in method transfer and validation in a GMP and non-GMP environment in accordance with current industry practices.
• Excellent analytical problem-solving mindset (escalate when needed) and can handle multiple tasks at the same time.
• Good technical writing skills and able to prepare protocols and reports. Able to draw up realistic project plan for method transfer/validation.
• Expertise in analytical technology (e.g. spectrophotometry, biological activity, potency binding ELISA, BIAcore, Octet, …) is a plus.
• Ability to work accurately while maintaining a strong focus on results and exhibiting a quality-oriented mindset.
• Ability to critically analyze data, draw scientifically sound conclusions, and formulate them correctly.
• Excellent knowledge of cGMP and can convert legal requirements regarding analytical methods into effective action plans.
• Team player and have good communication skills.
• Flexibility, stress-resistant, open to change & innovation, and used to working within deadlines.
• Willing to adapt to changing priorities and willing to learn at a rapid pace.
• Languages ; Dutch & English (fluent in writing and speaking)