Associate Principal Scientist, Quality Control

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. Scientist – Quality Control – Microbiology Are you looking for an exciting job in a fast-growing international CDMO organization producing new biological medicines? Do you enjoy working in a dynamic environment, where you every day will be involved in multiple different tasks of varying complexity? QC Microbiology is looking for a scientist in the Microbiology laboratory team The Department The Quality Control (QC) area at AGC Biologics in Søborg, consist of approximately 160 employees divided into two support department and tree testing departments. In QC we are responsible for supporting production of new biopharmaceuticals by controlling raw materials, performing analytical testing, environmental monitoring of productions rooms, planning and executing stability programs and validating various analytical methods according to ICH guidelines from clinical phase I to phase III and commercial. QC Microbiology department consists of QC Microbiology Laboratory team and QC Environmental monitoring team. The vacant position is as scientist in QC Microbiology Laboratory team (consisting of 14 highly dedicated technicians and scientists). The primary daily delivery in the team is testing of release, in-process, cleaning, utility and environmental monitoring samples and stability samples of our clinical and commercial products using various compendia methods (Bioburden, endotoxin, ID of species etc.). The team deliveries play an important role as part of the drug substance production and facility compliance. We also performs verifications/validations, handle deviations, CAPAs, invalid assays, OOS and change controls. The QC Microbiology department works in close collaboration with Manufacturing, Quality Assurance, Up- and Downstream Development, Analytical Development, other QC departments and external laboratories to maintain control of all steps in the manufacturing processes. Everything we do, we do in close collaboration with our customers. Tasks and Responsibilities You will be responsible QC Microbiology scientist for the microbiological analyses in the department, where evaluation of results and generation of project related GMP documentation will be a natural part of your daily work. Coordinate with external laboratories for bulk harvest analyses including virus- and mycoplasma analyses. Gathering data for reports, writing deviations and constantly optimizing procedures (SOP’s, TEQ’s etc.), ensure continuous GMP compliance with a LEAN mindset. Further, you will be involved in Validation of microbiological methods for the new projects. You will ensuring cGMP compliance and participate in customer audit and regulatory inspection, which, we as leading CDMO, experience a lot. This calls for a strong GMP mindset and experience. Further, AGC Biologics in Søborg is growing with new facilities for drug substances production. The new facility that soon will be ready, include new QC laboratories, where we are looking forward to moving into this year. This will give you a great opportunity to take part in projects with different departments due to exciting activities as part of the facility expansion. It is pivotal that you have interest in continuous improvement and process optimization. Your profile The ideal candidate holds a MSc or PhD degree in Microbiology or other relevant field and have some of the following qualifications: Knowledge of microbiology quality control in biopharmaceutical production Validation of microbiological methods GMP and biopharmaceuticals production Familiar with EMA, FDA, and ICH regulations for biologics Knowledge of cleaning validation including TOC validation Knowledge of virus and mycoplasma safety testing Enjoy working in close collaboration with your colleagues You are structured and responsible with respect for deadlines and quality Like to share your knowledge and communicate openly and professionally both internally and with external customers Good English communication and ability to effectively communicate with others engaging with customers and colleges of various cultural background Lean skills will be an advantage AGC has international customers and our company language is English. It is therefore vital to be fluent in written and spoken English. AGC offers AGC Biologics offers a dynamic working place and an excellent opportunity for working and growing with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a biologics contract development and manufacturing organization interact in order to achieve success. Exciting and challenging assignments will keep coming your way, but you will largely be able to plan your daily work on your own. AGC Biologics offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC employees have a flexible attitude and we help each other to reach deadlines together as one team, in accordance with our slogan - Right. On Time. We will process the candidates as they arrive. Therefore, please submit your application and CV as soon as possible. When the right candidates are found, the add will close. We are therefore looking forward to receiving your application today! For further information regarding the position, please contact Director, Susanne Vestergaard at 45 22942932. 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.