Scientist & Validation SME, QC Chemistry (18 months maternity cover)

<p><b>Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.</b></p><p></p><p><b><span>(Senior) Scientist &amp; Validation Subject Matter Expert (SME), QC Chemistry.</span></b></p><p><b><span>This role is a maternity cover for 1,5 years.</span></b></p><p></p><p><b><span>Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.</span></b></p><p></p><p><span>Are you motivated by method validations, troubleshooting and supporting analytical quality control (QC) activities in order to support clinical and commercial manufacturing for our Customers worldwide? Do you thrive in an international environment where teamwork and collaboration are on top of the agenda? Then we might have just the right opportunity for you as 1,5 years maternity cover in QC Chemistry!</span></p><p></p><p><b><span>The QC Chemistry Department:</span></b></p><p>QC Chemistry is one of five departments in the QC area. QC Chemistry is responsible for supporting the production of new or marketed biopharmaceuticals by performing analytical testing and validating various analytical procedures according to ICH guidelines from clinical phase I to phase III and commercial. QC Chemistry have a close collaboration within the QC area and with departments across the organization as well as AGC Biologics external Customers and external vendors.</p><p></p><p><b><span>The QC Scientist Role &amp; Responsibilities:</span></b></p><p>As (Senior) Scientist and Validation SME in QC Chemistry, it is required that you have expertise and ability to troubleshoot on chromatographic methods, especially (U)HPLC, iCIEF and CGE-SDS. You will be driving PhI/II and PhIII/Commercial method validation activities, review release and stability analytical set-ups, support lab technicians, author SOPs and run Lab Investigations, Deviations/CAPAs and CR cases. Since you will participate in method relevant Customer meetings and provide input for validation plannings, good communication skills are essential together with a general understanding of planning and coordination of activities.</p><p></p><p><b><span>Your Profile:</span></b></p><p>The ideal candidate holds a MSc or PhD degree in Biochemistry, Chemistry or other relevant area and has +3 years of work experience in QC or analytical development. Candidates with experience from PhIII Validations will have an added advantage. Fluency in written and spoken English is a requirement, since English is our company language.</p><p></p><p>You ideally bring some of the following experience:</p><ul><li>Working and troubleshooting experience with SE-, IEX- and RP-UHPLC, iCIEF and CGE-SDS analysis.</li><li>Experience with Chromeleon software and LIMS.</li><li>Technical experience in protein analytics testing and protein biochemistry.</li><li>Experience in validating analytical methods according to ICH guidelines for PhI/II and/or PhIII.</li><li>Experience with working in cGMP settings according to European and US regulatory guidelines.</li></ul><p></p><p>It is important to have a self-motivating personality with a pragmatic, solution oriented approach to the daily work, without compromising quality. You thrive in a dynamic environment and enjoy a rapid pace of work where we all work as one team. Also, you bring a positive, can-do attitude and a good sense of humor.</p><p></p><p>You ideally bring some of the following characteristics:</p><ul><li>Excellent communication, presentation, and interpersonal skills.</li><li>You like to share your knowledge and communicate openly and professionally, both internally and with external customers.</li><li>You are able to prioritize your own tasks in a dynamic environment.</li><li>You are a team player with ability to work independently.</li></ul><p></p><p><b><span>AGC offers:</span></b></p><p>AGC offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a contract manufacturing organization interact to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extend be able to plan your daily work yourself. AGC offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC’s employees have a flexible attitude, and we help each other to reach deadlines together as one team.</p><p></p><p><b><span>Application:</span></b><br/>Submit your application as soon as possible! We treat the applicat