CMC Specialist

CMC Specialist

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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. 

Apply now

    Our Hiring Process

    Stage 1:

    Internal Review

    This means that we’ve received your application and are in the process of reviewing it.

    Stage 2:

    Initial Call

    We’ll set up a 15-minute phone call with our Internal Recruiter to discuss the details of this job opportunity and your own expectations of the role, as well as Merus as a company.

    Stage 3:

    1st Interview Phase

    During the 1st interview phase, we’ll set up an interview with your potential future manager. We’ll be looking to understand more about your experience, how that fits the role, and what makes you tick.

    Stage 4:

    2nd Interview Phase

    If things are still looking good, we’ll set up several short interviews with team members, peers, Management Team members (where relevant) and HR to make sure we are a good cultural fit. We do our best to plan these interviews on the same day, although on rare occasions they’ll take place on multiple days.

    Stage 5:

    Job Offer

    After positive evaluation from both sides, you will receive our job offer. Once you’ve accepted it, we will draw up the necessary paperwork. You will receive your contract within 3-5 working days and your onboarding process will start!

    Stage 6:

    Welcome

    We’re more than happy to welcome you to join Merus in our pursuit to close in on cancer!

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    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.

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