Magnet.me  -  Het slimme netwerk waar studenten en professionals hun stage of baan vinden.

Het slimme netwerk waar studenten en professionals hun stage of baan vinden.

CMC Specialist

Geplaatst 27 mrt. 2025
Delen:
Werkervaring
5 tot 10 jaar
Full-time / part-time
Full-time
Functie
Soort opleiding
Taalvereiste
Engels (Vloeiend)

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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.

Equal Employment Opportunities

Merus is an equal employment opportunity employer that does not discriminate on the basis of actual or perceived race, color, religious creed, national origin, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, age, ancestry, disability or perceived disability, qualified handicap, gender identity, military status, veteran status, certain criminal records, genetic information or testing, HIV testing, or any other characteristic protected by applicable federal, state or local laws (each, a "Protected Characteristic"). We are dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.

Fraudulent Recruiting Activities

Please be cautious of scam recruitment offers claiming to be from Merus. Such scams may come from various sources, including unsolicited email using Gmail or other non-Merus email addresses or via text. These scams seek to obtain personal information or payment from victims by offering jobs that do not exist. If you have been the victim of such a scam, please report it to the Internet Crime Complaint Center (IC3) if you are living in the US or report it to the police if you live in the Netherlands.

At Merus, we are clinically advancing leading-edge, targeted treatments to address the unmet needs of patients with various types of cancer. Utilizing our proprietary technology platforms, we are developing innovative multispecific antibody therapeutics, referred to as Multiclonics.
Deze bedrijfspagina is automatisch gegenereerd en bevat daarom nog weinig informatie. Je vindt meer informatie over ‘bedrijfsnaam’ op hun website: ‘’Carrierewebsite’’

Chemie
Utrecht
140 medewerkers