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. For our ambitious, fast-growing team in Copenhagen, we are looking for an MSAT Scientist working in the Manufacturing Science Department (MSAT) team, you will take a leading role in supporting commercial projects and ensuring the success of biopharmaceutical processing activities. About the Job AGC Biologics continues to enjoy great success with a steadily increasing number of projects, many of which are late-stage development projects preparing for commercial launch. Simultaneously, we are supporting processes already running in our GMP facility for commercial supply. With AGC Biologics’ increasing activities, we are looking for a new colleague within Manufacturing Science to support commercial projects. Depending on your level of qualification, you will take part in key upstream/downstream process activities in several projects, both within microbial and mammalian processing. About the Department The Manufacturing Science Department currently consists of 6 team members, and the team is about to expand. You will be part of this growing team, characterized by open communication, strong support, and flexibility within the team and between departmental teams. You will… Handle impact assessments for deviations in commercial projects. Assess process-related change requests and supporting change implementation for commercial projects. Support manufacturing activities such as process improvements, risk and gap assessment, and drafting technical protocols/reports (APQR). Strong collaboration with teams including Manufacturing, Quality Assurance, Quality Control, and Process Development. Apply technical and scientific expertise in support of program operations. Conduct critical reviews of technical documentation and maintaining an overview of documentation packages. Support internal teams and clients to resolve critical operational and technical issues. Drive deviations and OOS/OOT investigations and assisting in major and critical CAPA action plans. Participate in or driving technical task forces to solve critical issues impacting USP/DSP processes. Support post-approval regulatory interactions, including inspections. Represent MSAT in cross-functional teams. This position offers interaction with numerous stakeholders and is unique in having contact with both our customers and internal teams. You will be introduced to biopharmaceutical companies from around the world and will actively participate in their projects. The department primarily operates in an office environment, so no laboratory or manufacturing hands-on work is expected. You have… PhD, MSc, B.Sc, or B.Tech in biochemistry, biotechnology, engineering, or a similar educational background. 3 years of experience in biopharmaceutical development and/or manufacturing, and/or Manufacturing Science and Technology (MSAT). Experience and knowledge of biopharmaceutical upstream or downstream unit operations. Excellent English communication and collaborative skills. A flexible approach and a desire to take on and drive new tasks and responsibilities. Are you up for a challenge? Apply with your CV (In English please) If we see a match, you’ll have a call with one of our recruiters to share more about what you can bring to the team. Are both sides still positive? Then we proceed to the assessment stage to assess key skills required for the job. We will be conducting interviews on an ongoing basis and will close the position once the successful candidate has been found. Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook! AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances. AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.