AST Analytical Project Lead

Responsibilities

• Be a part of the Analytical Science and Technology Team.
• 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.

Requirements

• You have a PhD in Life Sciences or are equivalent through experience.
• You have expertise in method transfer and validation in a GMP and non-GMP environment in accordance with current industry practices.
• You have an excellent analytical problem-solving mindset (escalate when needed) and can handle multiple tasks at the same time.
• You have good technical writing skills and are able to prepare protocols and reports. As well as drawing 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.
• You have the ability to work accurately while maintaining a strong focus on results and exhibiting a quality-oriented mindset.
• You have the ability to critically analyze data, draw scientifically sound conclusions, and formulate them correctly.
• You have excellent knowledge of cGMP and can convert legal requirements regarding analytical methods into effective action plans.
• You are a team player and have good communication skills.
• You are flexible, stress-resistant, open to change & innovation, and used to working within deadlines.
• You are willing to adapt to changing priorities and willing to learn at a rapid pace.
• Travel might be required as part of this role (up to 10% of the time)