CMC Director (ADCs)

Are you ready to make a groundbreaking impact in the world of biotechnology? Join a growing company that's shaping the future of healthcare and science.

Proclinical is seeking a dedicated CMC Director specializing in Antibody-Drug-Conjugates (ADCs) to join our client's team on a permanent basis. This role focuses on advancing the development and manufacturing processes of ADCs, contributing to innovative cancer treatments.

Responsibilities:

• Manage external CMC-related development and manufacturing activities for product candidates.
• Monitor project plans and timelines, ensuring alignment with process development outcomes.
• Ensure compliance with scientific principles, regulatory guidelines, and GMP, GLP, GDP standards.
• Prepare and review technical documents related to development, manufacturing, validation, and transfer plans.
• Lead and participate in cross-functional subteams.
• Support contractor selection and performance monitoring for CMC activities.
• Assist in preparing and reviewing regulatory submissions.
• Evaluate change controls and deviations in CMC activities.
• Report proactively on the status and planning of CMC activities.
• Detect and escalate conflicts with contractors as necessary.

Key Skills and Requirements:

• Master's degree in a relevant biomedical field.
• Expertise in CMC of ADCs within the biotech or pharma industry.
• Experience in antibody/ADC development and manufacturing.
• Understanding of quality systems such as GMP, GLP, and GDP.
• Strong organizational skills and attention to detail.
• Effective communication skills in English; Dutch is a plus.

If you are having difficulty in applying or if you have any questions, please contact Ruhee Saleh at r.saleh@proclinical.com.

Apply Now:

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Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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