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

Posted on : 10 April 2017

Project Description

Senior Biological Critical Reagent (BCR) Specialist  Quality Operations-QUA005553DescriptionThe departmentQuality Operations at MSD Biotechnology Operations Oss (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.For more information about MSD Biotech, please watch the MSD Biotech Oss video below. positionThe 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 Biologics franchises;- Support distribution (in time delivery) of BCRs to MSD laboratories, contract laboratories and regulatory agencies;- Provide bioanalytical support and knowledge 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.QualificationsDesired 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 MSDMSD 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.MSD. Be well. For more information, visit our website: www.werkenbijmsd.nlA good place to workOur 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.InformationFor more information about the position, please contact Marleen Langenhuizen-van de Ven, by phone via: +31 4126 66327 or +31 (0)6 11 53 18 29 or Marc Bastiaansen via: +31 4126 62439 or +31 (0) 3033 8345 ,heading the BCR team.ApplicationIf you are interested in this challenging role, you are invited to apply online by uploading your resume and application letter in English.Recruitment Agency / Search Firm representatives please note:MSD will not accept unsolicited CVs from recruitment agencies / search firms under any circumstances. In order to present CVs to MSD, your Recruitment Agency / Search Firm will have been invited to work on a specific vacancy and have Terms of Business signed and agreed with the relevant Recruitment and Staffing Regional Lead. Should you send CVs for a vacancy that you have not been specifically invited to work on to any employee at MSD (via email, post, internet, Taleo or any other method), these will be deemed the sole property of MSD. MSD will pay no introduction fee to the Recruitment Agency / Search Firm if a candidate is hired as a result of an agency introduction under these circumstances.Job: Quality Ops Tech Supply Job Title:Senior Biological Critical Reagent (BCR) Specialist  Quality OperationsPrimary Location: EMEA-Netherlands-NB-OssEmployee Status: RegularTravel: NoNumber of Openings: 1Company Trade Name:MSD Job Segment: Biochemistry, Biotech, Operations Manager, Scientist, Science, Operations


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