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Biological Critical Reagent (BCR) Specialist – Quality Operations Job - Netherlands
Posted on : 10 April 2017
- Our company 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’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
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 company laboratories, contract laboratories and regulatory agencies;
- Provide bio analytical support to our Manufacturing sites, Laboratories and other functional groups as needed;
- Provide bio analytical 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.
- 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 English (Dutch is a plus).
A good place to work
- Our employees are the key to our company’s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
- Our company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
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