The Scientific Technical Specialist is responsible for:
•Supporting transfer of BCRs of new Biological products from our Manufacturing Division Commercialization / our Research Laboratories to the BCR Hub;
•Supporting complete life cycle (acquisition, qualification, implementation, ongoing monitoring and stability) of BCRs within the global Biologics franchises;
•Supporting distribution (in time delivery) of BCRs to MSD laboratories, contract laboratories and regulatory agencies. The BCR Specialist will be responsible for supporting Biological Critical Reagent (BCR) programs within the Biologics franchises. This position requires experience in general analytical biochemistry or immunochemical techniques. The BCR Specialist is responsible for managing the complete life cycle of reference materials, control samples and other materials used in support of release and stability testing of biological products. Primary responsibilities include, but are not limited to the following:
•Support transfer of BCRs of new Biological products from our Manufacturing Division Commercialization / our Research Laboratories to Biotech BCR Hub;
•Support complete life cycle (acquisition, qualification, implementation, ongoing monitoring and stability) of BCRs within the global Biologics franchises;
•Support distribution (in time delivery) of BCRs to MSD laboratories, contract laboratories and regulatory agencies;
•Provide bioanalytical support to our Manufacturing sites, Oss Laboratories and other functional groups as needed;
•Provide bioanalytical support in responding to regulatory questions, authoring appropriate CMC sections or appropriate technical support during regulatory inspections;
•Conform to current Good Manufacturing Practices (cGMP) as they apply to the functions of the group;
•Support/drive required GMP/GLP activities like change requests, deviation notifications/management.
•Bachelor’s/ Master’s degree in Biology, Chemistry, Biochemistry, or a related biological science;
•Experience (1–2 years for a Master’s and 2-4 years for a Bachelor’s degree) in the areas general biochemistry, analytical biochemistry or immunochemical techniques;
•A thorough understanding of Bio-analytical methods (Elisa, HPLC, CE-SDS) and validations.
•Basic to strong technical knowledge and a high level of technical performance;
•Ability to achieve productivity by managing time, priorities and personal effort in a fast-paced environment. Additional requirements;
•Strong understanding of GLP/ GCP/ GMP regulations, with the ability to apply these practices daily;
•Statistical Analysis experience with familiarity with JMP or Minitab;
•Strong ability to work either independently as well as in teams and the ability to coordinate activities for multiple projects as needed to meet timelines;
•Strong project management skills, innovative abilities and strong drive to improve (preferably Green Belt certification);
•Strong persuasive and influencing skills;
•Strong written and oral communication skills (in both English and Dutch).
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