Merus zoekt een
Associate Director/Director, CMC Antibody-Drug-Conjugates (ADCs)
Utrecht, Netherlands
As a member of our CMC (Chemistry, Manufacturing & Control) Team you will play an important role in the cell line, process, analytical and formulation development, and drug substance and drug product manufacturing of antibody-drug-conjugate (ADC) leads, and contribute to the development of groundbreaking new medicines for the treatment of cancer. Joining Merus means joining our pursuit to develop advanced therapies that address unmet needs in cancer treatment.
Your role
As (Associate) Director CMC ADCs, your main tasks and responsibilities are the following:
- Managing (parts of) external CMC-related early and late stage development and manufacturing activities of Merus’ product candidates;
- Monitoring and updating project plans and timelines in relation to the outcome of process development work; managing critical path activities to prevent program delays;
- 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;
- Preparing/reviewing technical documents including development/manufacturing/validation/ transfer plans, reports and other critical documents of (outsourced) CMC activities;
- Leading/participating in cross-functional subteam(s);
- Selection and performance monitoring support of Contractors for CMC activities;
- Preparation and reviewing support for regulatory submissions;
- Evaluating change controls and deviations related to CMC activities;
- Reporting on status and planning of CMC activities on a pro-active basis;
- Ensure that conflicts between Merus and Contractors are timely detected and properly escalated where needed.
Your profile
We are looking for an (Associate) Director CMC ADCs with the following knowledge and expertise:
- You hold at least a Master’s degree in a relevant biomedical field, and have at least 5 years of experience in CMC of ADCs in the biotech or pharma industry;
- Experience in antibody/ADC development as well as antibody/ADC drug substances and/or drug product manufacturing;
- You have good understanding of various quality systems such as GMP, GLP and GDP;
- You are a team player focused on results and on the quality of your work;
- 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.
Our offer
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.