Overzicht


  • Support the complete life cycle (acquisition, qualification, implementation, ongoing monitoring and stability testing) of BCRs;

  • In time delivery of qualification reports and certificate of analysis of BCRs;

  • Work according to cGMP guidelines and manage activities like change request and deviation management;

  • Provide bioanalytical support to our manufacturing sites, Oss laboratories and other functional groups as needed;

  • Author and review appropriate documents for regulatory assessments;

  • Leads and participates in root cause investigation teams;

  • Provide bioanalytical and technical support in responding to regulatory questions;

  • Support the distribution of BCRs to MSD as well as contract laboratories and

  • regulatory agencies;

  • Support the transfer of BCRs of new Biological products from our Manufacturing Division Commercialization or Research Laboratories to the BCR Hub.

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The BCR Hub in Oss, The Netherlands (around 20 employees) is part of a global Hub organization within MSD and responsible for managing the complete life cycle of materials and samples that are used as critical reference parameters in release and stability testing of biological products, named BCRs. Consequently, market release of these products results in worldwide distribution of our well known healthcare products like Keytruda, Puregon and Elonva.

  • Bachelor’s/ Master’s degree in (immuno)biology, (bio)chemistry, or a related field;

  • Ability to achieve productivity by managing time, coordinate activities for multiple projects with changing priorities and personal effort in a fast-paced environment as expressed by excellent project management skills;

  • Strong written and oral communication skills (in both English and Dutch);

  • Relevant experience in the areas of (analytical) biochemistry or (immuno)chemical techniques expressed by good theoretical understanding of bio-analytical methods (EIA, HPLC, CE-SDS) and validation strategies. Practical experience with (one or more) of these techniques is strongly preferred;

  • Throughout understanding of cGMP regulations, with the ability to apply these practices on a daily basis;

  • Statistical analysis experience preferably with JMP or Minitab;

  • Strong ability to work independently as well as in a team setting;

  • Innovative abilities, strong persuasive and influencing skills and a strong drive to work on continuous process improvement.

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Categorie:
Ervaring: Full-time

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