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Director Biologic and Vaccines Analytics Netherlands,  


Posted on : 22 April 2017

Project Description

Director Biologics and Vaccines Analytics-BIO004747DescriptionFor our GVBC/BVA (Biologics and Vaccines Analytics - Oss) organization in Osswe are currently looking for a:Director Biologics and Vaccines AnalyticsAbout 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.nlThe departmentThe Global Vaccines and Biologics Commercialization organization (GVBC) is a global commercialization team supporting all of MSD s late stage pipeline and in-line large molecule therapeutics (biologics and vaccines). GVBC-Biologics and Vaccines Analytics (BVA) provides broad analytical support to commercialization of vaccines and biologics. Furthermore, GVBC-BVA plays a crucial role in supporting corresponding Lines of Business (LoB), Global Technical Operations (GTO), and the Quality organizations. As part of the GVBC organization, analytical and process Centers of Excellence are located in the US and Oss (The Netherlands). These teams are regionally responsible for introducing new processes (Biologics Process Development and Commercialization, BPDC) and analytical methods (Biologics and Vaccines Analytics, BVA) into the commercial operations space and for support to LoB, GTO and Quality. For pipeline Biologics, the Oss BVA organization is responsible for tech transfer, implementation and validation of analytical methods at regional commercial manufacturing and testing sites (including MSD-Oss, CTOs and CMOs located globally). In addition, BVA Oss is responsible for deep scientific support to investigations (trouble shooting and analytical improvements such as analytical lifecycle initiatives).The positionReporting into the Executive Director Biologics and Vaccines Analytics (US based) you will be responsible for analytical implementation at regional commercial testing sites (including MSD-Oss (de Geer) and CMOs in Europe). You will be responsible for assay robustness and lifecycle initiatives and deep technical support to investigations. You will have 5-10 direct reports, (Associate) Principal Scientists and analytical leads and so you will be responsible for an organization of approximately 20 -30 employees in total. You will have budget accountability for the BVA Oss organization.Other tasks and responsibilities:Analytical Tech Transfer " Accountable for tech transfer of analytical methods to commercial manufacturing and testing facilities (MSD-Oss or external CMO/CTO) for testing of therapeutic proteins and potentially vaccines; " Interfacing with late stage analytical development (GVBC BVA West Point/Research Labs), technical operations and analytical development peers to ensure efficient and effective transitions.Technical/scientific leadership " Accountable for providing technical and scientific support to new commercial biologics (e.g. technical support/trouble shooting) in EU area including MSD-Oss facilities, and globally as required; " Accountable for successful project management of relevant analytical programs; " Accountable for the scientific quality and on-time delivery of analytical development studies and related documentation.Compliance " Accountable for the cGMP quality of all BVA deliverables including input in deviations, and change management according to MSD s quality system; " Ensuring full traceability of data and reports in line with current requirements including Technical Knowledge Management; " Accountable for department s compliance (EHS/Q).Innovation " Creating and stimulating an open culture of high technical quality and innovation in the department; " Accountable for implementing new analytical platforms in cross-functional late stage analytical development and QC teams.Filing support " Ensuring that BVA-Oss organization delivers high quality support to all filings; " Accountable for Analytical related RtQs from HAs regarding filing content with BVA -Oss accountability (e.g. Keytruda; MK-3222; AIT programs).QualificationsRequired " PhD in biological sciences, biochemistry, or biochemical engineering; " At least 5-7 years of relevant experience in managing biotechnological analytical development projects and analytical tech transfer activities; " Relevant experience with cGMPs and involvement with QC analytical activities; " Relevant assay development, validation and protein chemistry experience; " Proven strong scientific and project management skills; " Knowledge of regulatory and quality guidelines; " Full understanding of cGMPs and industry best practices in Quality functions, including method validation, transfer, lifecycle management and global business acumen; " Excellent analytical and technical skills; " Strong direct and indirect people management skills; " Strong team builder and leader with mature and exemplary interpersonal skills; " Demonstrated initiative and innovative process-oriented thinking within a team environment; " Strong communicator and ability to build bridges between groups and global organizations; " Excellent oral and written communication skills in English.Preferred " Experience in drafting product registration files; " Experience in analytical sciences; " Communiction skills in Dutch.A 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 livesInformationFor more information about this position you can contact Garry Takle, Executive Director Biologics and Vaccines Analytics , by phone: +1 215 99 32 117.ApplicationIf you are interested in this challenging role, you are invited to apply online by uploading your resume and application letter in English.Job: Biologics, Vaccines, Analytical Formulat Job Title:Director Biologics and Vaccines AnalyticsPrimary Location: EMEA-Netherlands-NB-OssEmployee Status: RegularTravel: NoNumber of Openings: 1Company Trade Name:MSD Job Segment: Data Analyst, Analytics, Biochemistry, Biotech, Law, Data, Management, Science, Legal

Locations

Oss NL

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