Senior Scientist Analyical Mehtod Development

<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>We are looking for an expert Senior Scientist with experience in the characterization and analysis of protein-based biotherapeutics. The ideal candidate has a strong interest in analytical characterization of biotherapeutics, employing methods such as LC-MS, HPLC, and <span>electrophoretic-based</span> assays. This position is anchored in the Characterization &amp; HPLC team within the Analytical Method Development (AMD) Department at AGC Biologics A/S, Copenhagen site.</p><p></p><p><b>About the Department</b><br/>The Analytical Method Development (AMD) Department consists of 26 dedicated and highly skilled scientists and technicians divided into two sub-teams: Characterization &amp; HPLC and Bioassay. The department’s key responsibilities include:</p><ul><li><p>Implementation, transfer, and development of analytical procedures.</p></li><li><p>Transfer of analytical methods to QC for validation.</p></li><li><p>Providing analytical support to early-stage and late-stage process development teams.</p></li><li><p>Characterization of biotherapeutic products and drug intermediates.</p></li><li><p>Routine testing of characterization assays.</p></li></ul><p></p><p>Projects span from early pre-clinical development through all clinical phases to commercial supply. AMD also contributes to cross-functional project groups and implements new analytical technologies and techniques. The department collaborates closely with counterparts at AGC Biologics’ facilities in Seattle (USA), Boulder (USA), Heidelberg (Germany), and Chiba (Japan).</p><p></p><p>The department fosters an informal and collaborative work environment, with a professional and flexible approach to work. We promise an exciting and diverse role with ample opportunities for professional growth.</p><p></p><p><b>About the Team</b><br/>As a Scientist in the Characterization &amp; HPLC team, you will develop a variety of analytical methods, including intact mass analysis, peptide mapping, glycan analysis, and other chromatographic and electrophoretic techniques. Your work will support a wide range of protein-based drug products, ensuring high-quality outcomes for our customers and enabling rapid market access. You will collaborate with a team of 9 scientists and 7 technicians and work closely with multiple stakeholders, including process development teams, project managers, and QC teams.</p><p></p><p><b>About the Role</b><br/>This role offers the opportunity to work with diverse drug products in different clinical stages and to apply your expertise in a cross-functional, interactive environment.</p><p></p><p>Your Primary Tasks Will Include...</p><ul><li><p>Evaluating methods received from clients prior to their implementation at AGC.</p></li><li><p>Transferring, developing, and implementing analytical methods for challenging biopharmaceuticals, including method documentation.</p></li><li><p>Performing pre-validations to ensure methods are suitable for QC use.</p></li><li><p>Processing and reviewing analytical routine testing for biopharmaceutical characterization.</p></li><li><p>Troubleshooting analytical methods and instruments.</p></li><li><p>Representing AMD in cross-functional project teams.</p></li><li><p>Providing verbal and written reports to clients.</p></li></ul><p></p><p>Your Qualifications....</p><ul><li><p>Advanced education in Protein Chemistry, Biochemistry, Biochemical or Chemical Engineering, or a related field (MSc or PhD preferred).</p></li><li><p>Preferably 4+ years of experience in analytics within the biotech industry.</p></li><li><p>Strong practical experience with LC-MS methodologies for proteins.</p></li><li><p>Experience in handling and analyzing biopharmaceuticals.</p></li><li><p>Preferably theoretical and hands-on knowledge of electrophoretic and HPLC-based methods, e.g., iCE, CE-SDS, SEC, IEX, RP.</p></li><li><p>Preferable understanding of sub-visible particle analysis (e.g., HIAC, MFI).</p></li><li><p>Familiarity with biopharmaceutical manufacturing and regulatory requirements.</p></li><li><p>Experience with analytical instrumentation such as HPLC, electrophoretic systems, and LC-MS systems.</p></li><li><p>Ability to work independently in a dynamic environment.</p></li><li><p>Strong interpersonal and communication skills.</p></li><li><p>Excellent English communication skills, both written and verbal.</p></li></ul><p></p><p><b>Application</b></p><ul><li><p>To apply, please submit your CV. We encourage you to apply even if you do not meet every requirement.</p></li><li><p>If we see a potential match, one of our recruiters will contact you to discuss your application.</p></li><li><p>If both sides remain positive after this discussion, we