CMC Specialist
CMC Specialist
Your Role:
- Supporting early and late stage development activities through scientific and technical input to plans, reports and other critical documents of (outsourced) CMC activities;
- Ensuring that process development and manufacturing activities are conducted in line with good scientific principles and design, in compliance with regulatory guidelines and according to GMP, GLP and/or GDP, where applicable;
- Prepare/review technical documents including development/validation/transfer protocols and reports;
- Evaluating change controls and deviations related to CMC activities;
- Participating in cross-functional subteams;
- Providing day-to-day expertise to CMC project teams on manufacturing and other development activities, manufacturing scale-up considerations and GMP operations;
- Provide input and review support for regulatory submissions;
- Reporting on status and planning of CMC activities on a pro-active basis.
Your Profile:
- You hold at least a Master’s degree in a relevant biomedical field, and have at least 5 years of experience in CMC in the biotech or pharma industry;
- Experience in antibody development as well as antibody drug substances and/or drug product manufacturing is a strong pre;
- You have good understanding of various quality systems such as GMP, GLP and GDP;
- You are known for your organizational skills, accuracy and drive to continuously improve your work;
- You communicate well in English, both verbal and in writing.
Why Merus?
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