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Senior Biological Critical Reagent (BCR) Specialist – Quality Operations Job - Netherlands  

Company managed [?] Still accepting applications

Posted on : 10 April 2017

Project Description


Description
The department
  • Quality Operations at company  Biotechnology Operations (around 100 people) has the following five sub-functions: Quality Assurance, Quality Systems, Quality IPT, Quality Control and Biological Critical Reagents. 
  • The Quality Department must ensure adequate quality systems are in place to support the manufacturing, packaging, testing, storage, and distribution of products according to our manufacturing division’s Policies, Guidelines, Procedures and regulatory requirements by appropriate oversight and monitoring.


The position
  • The Senior 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 Senior 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 Biologic franchises;
  •  Support distribution (in time delivery) of BCRs to company  laboratories, contract laboratories and regulatory agencies;
  •  Provide bio analytical support and knowledge to our Manufacturing sites,  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.



Qualifications
Desired skills & experience
  •  Master’s or PhD degree in Biology, Chemistry, Biochemistry, or a related biological science;
  •  At least five years of experience  in the areas general biochemistry, analytical biochemistry or immunochemical techniques;
  •  At least several years of experience and up to date knowledge on GMP and regulatory requirements in the pharmaceutical industry;
  •  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 and proven leadership capabilities to lead investigational teams, as needed;
  •  People management potential is a plus for this function.


Additional requirements:
  • 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, but also a good team player;
  • Strong written and oral communication skills in English (Dutch is a plus);
  • Preferably experienced and knowledgeable to translate appropriate business processes into accurate Standard Operating Procedures or Quality Systems.


About Us:
  • Our company  is working to help the world be well.
  • Through our medicines, vaccines, biologic therapies and animal health products, we work in more than 140 countries to deliver innovative health solutions to patients and animals. 
  • We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them. 
  • Our company  has a workforce of almost 4500 in the Netherlands at three main sites.
  • Our employees are the key to our company’s success. 


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.

  
Job Segment:  Biochemistry, Biotech, Operations Manager, Scientist, Science, Operations