Merus zoekt een
CMC Specialist
Utrecht, Netherlands
As a member of our CMC (Chemistry, Manufacturing & Control) Team you will play an important role in the cell line, process and formulation development and drug substance and drug product manufacturing of bispecific antibody leads, and contribute to the development of groundbreaking new medicines for the treatment of cancer.
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?
We offer a competitive salary and flexible working hours. Our talented international team works in an inspiring area of Utrecht (Utrecht Science Park) in a brand new state-of-the-art facility. We also offer an excellent pension scheme, company bonus, and 30 days’ annual holiday based on a full-time position. We care about team spirit and organize several company events each year.