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Associate Director for QC Microbiology and Environmental Monitoring

FUJIFILM Diosynth Biotechnologies
Hillerød, Denmarkfull_timeVerifiedPosted 3 Dec 2024

About the role

<p>Are you a people manager and eager to join a fast-growing pharmaceutical company? Now you have a unique opportunity as we are looking for an Associate Director who <span>shares our passion, drive, and energy – what we call <b>Genki.</b> </span></p><p></p><p><b>About FUJIFILM Diosynth Biotechnologies and our Quality Control Department</b></p><p>FUJIFILM Diosynth Biotechnologies is a world leading Contract Development Manufacturing Organization (CDMO) serving customers in the pharmaceutical industry – from pre-clinical investigations to commercial GMP production. Our overall mission is to “Advancing Tomorrow’s Medicines” and we like to invite you to be part of that journey.</p><p></p><p>Our Quality Control (QC) department at site Hillerød consists of approximately 240 employees divided into different support teams and three testing teams. In QC we strive towards a OneQC team spirit where we help and support each other across teams not only to reach our goals but also to support a high level of collaboration and possibilities for personal development. The pillar in our QC department is our employees – our success is only possible due to competent and dedicated colleagues, who wants to make a difference for QC, our site, our customers, and patients all over the globe. As a leading CDMO company we, in QC, are obligated to continuously improve our way of working creating a dynamic and inspiring environment with huge individual co-decision making due to our flat organizational structure.</p><p></p><p>The culture at FUJIFILM Denmark (FDBD) is key, and besides a competitive salary and bonus package, we offer health insurance, massage and physiotherapy, health check, fitness center, possibility to work from home and most recently we invested in a mobile barista coffee van. FDBD also has a canteen arrangement incl. Friday brunch and monthly afternoon cake, just as we have a “bell ringing” tradition when reaching important milestones.</p><p></p><p><b>About the Department</b></p><p><span>The QC Microbiology department currently consists of &gt;50 dedicated employees (analysts, scientists, student helpers, and a leadership team). The department</span> consists of 5 teams and supports the global release of commercial products (DS/DP) for our customers with various pharmacopeia Microbiology methods (e.g. Bioburden, Endotoxin, CCI, SVP, BacT, microbial ID etc), as well as supporting the biologic Drug Substance (DS) manufacturing during investigations and with environmental monitoring (EM) and utility monitoring (UM) of the facility. Method suitability testing (MST) and concurrent qualification of the customers samples during the production are becoming a key deliverable for the department with the many new customers that FDBD is transferring into the new DS manufacturing facility. Besides supporting DS manufacturing – FDBD are establishing a new a Fill &amp; Finish facility for Drug Product (DP) where the department is heavily involved with EM/UM of the new DP manufacturing facility, as well as implementing sterility testing of DP. Lastly the department are involved in documentation of <span>deviations, CAPAs, invalid assays, OOS and Change Controls and much more. All this is part of our daily activities in respect of getting the commercial products out to the patients.</span></p><p></p><p><b><span>About the Position</span></b></p><p><span>When working at FUJIFILM Diosynth Biotechnologies Denmark you will, besides from the tasks listed below, onboard new customers and products to the site, build a network across QC and FDBD, support our site expansion project, and assist in finding new and innovative ways of working smarter in a complex everyday life.   </span></p><p></p><p><span>As an Associate Director for the QC Microbiology department, you will </span><span>provide direct leadership of a management team of 5 dedicated Associate Managers.</span><span> The lab technicians are working 7 days a week in normal working hours. You will have two Associate Directors and a Continuous Improvement scientist as colleagues, and together you will provide leadership, establish direction and prioritization to the entire QC testing department, of approximately 100 employees, together with your colleagues and the Director for the QC testing teams. You will </span><span>ensure that we work in accordance with our core values - trust, delight our customers, Gemba (go see), and Genki (enthusiasm)</span><span>. The department and our organization will continue to expand and adapting due to the site expansion where we in 2025 expect a 3x DS manufacturing and one new DP manufacturing facility on site Hillerød. </span></p><p></p><p>You will be reporting into the Director of QC Testing Teams.</p><p></p><p><span>Your primary tasks will be but not limited to:</span></p><ul><li>Provide leadership and drive development of your department and Associate Managers</li><li>Set direction and structure, ensure motivation in the team, and prioritize tasks<

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FUJIFILM Diosynth Biotechnologies

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