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. 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 people manager to one of our two teams. About the Department and QC area 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 manager for 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 department works in close collaboration with Manufacturing, QA, Up- and Downstream Development, Analytical Development and external laboratories to maintain control of all steps in the manufacturing processes. Everything we do, we do in close collaboration with our customers. The work at QC Microbiology department includes a broad scope of tasks together with many different products and customers. Unlike traditional pharma companies, the work at AGC never becomes routine and gives you new knowledge and experience continuously. The position requires an engaged, ambitious leader with interest in people, teamwork, knowledge of Microbiology and GMP biopharmaceuticals production. Tasks and Responsibilities We are looking for a people manager for our QC Microbiology Laboratory team that can ensure together with your team are thriving and meeting the deliverables and goals. You are not expected to be an expert in all listed areas, but you must be able to act as a sparring partner for your team on various subjects. Apart from taking care of your team, you will ensure close collaboration and be responsible for cross-organizational activities associated with internal stakeholders as manufacturing, development, QA and other QC departments. As manager of QC Microbiology lab. Team you must create a positive, motivating and productive working climate in accordance with AGC Biologics values. You will be responsible for ensuring cGMP compliance and participation in customer audit and regulatory inspection of 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, and have focus on new technologies and automation to be implemented in the QC Microbiology laboratory as we continuously improve our way of working. Your profile In our new people manager, we are looking for a person with: Degree in science, engineering, or a related field (MSc. or PhD) Knowledge of microbiology quality control in biopharmaceutical production 3 year experience in a regulated (cGMP) manufacturing environment Preferably 3 year as a team leader or manager Ability to apply organizational skills to systems and efficiency improvement Good English communication and ability to effectively communicate with others engaging with customers and colleges of various cultural background, with an ability to obtain buy-in from all key stakeholders Familiar with EMA, FDA, and ICH regulations for biologics Strong driver of interdepartmental tasks with the ability to keep the end goal in mind and prioritize between many different tasks Open, curious and motivated by succeeding through your team Can-do attitude and look for solutions with an open and communicative approach Lean skills will be an advantage Key responsibilities: Provide leadership and drive the development of your team Set direction, motivate the team and prioritize tasks Manage a growing team and ensure the right competencies in the team Ensure that we deliver in accordance with our agreement with our customers and internal in AGC Ensure alignment with your peers across QC/AGC Biologics and build an efficient team Challenge the status quo and drive a continues improvement culture Ensure the right quality level and cGMP compliance Proactively secure a healthy work environment with a safety-first culture Reports and updates to department manager on the team's progress The daily challenges will vary a lot, and two days will never be the same 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 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, and you will largely be free to plan your daily work on your own. AGC Biologics offers an informal working environment with multiple cultures, 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 reach out to help each other to meet deadlines as one team. In accordance with our slogan – “Right. On Time”. We will process the candidates as they applying. 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 receive your application today! For further information regarding the position, please contact. Sr. Manager, Susanne Vestergaard at 45 22 94 29 32. 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.