Manager, 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.

Are you looking for an exciting job in a rapidly growing international CDMO organization that produces new biological medicines? Do you thrive in a dynamic environment where you can take on a variety of tasks with different levels of complexity? The QC Microbiology department is seeking a Manager for the Scientist group! Learn more about this opportunity below and apply today!

The QC Microbiology Department:

The Quality Control (QC) department at AGC Biologics in Søborg is comprised of approximately 160 employees organized into five areas: QC Microbiology, QC Bioassay, QC Chemistry, QC Support and QC Planning & Systems. In the QC area, we support the production of new biopharmaceuticals by overseeing raw materials, conducting analytical testing, monitoring the environment in production rooms, planning, and executing stability programs, and validating various analytical methods according to ICH guidelines for clinical phase I to phase III and for commercial use.

The QC Microbiology department consists of two teams: the QC Microbiology Laboratory (ML) team and the QC Environmental Monitoring (EM) team. We are currently seeking a manager for the QC Microbiology Scientists, which includes 4 EM Scientists and 6 ML Scientists. The primary responsibilities of the Scientist group include serving as QC Scientists for a clean room environment and conducting related microbiological analyses within the department. They evaluate and approve results, generate project related GMP documentation, gather data for reports, write deviations and change requests, and continuously optimize procedures (such as SOPs and TEQs) to ensure ongoing compliance with cGMP under a LEAN framework. Furthermore, the Scientists are responsible for requalifying clean rooms for EM, do method validation and addressing EM and microbiological issues related to customer projects and audits.

Our team’s contributions are vital to both drug substance production and facility compliance. The QC Microbiology department collaborates closely with Manufacturing, QA, and Development departments, as well as external laboratories, to maintain control throughout all steps of the manufacturing process. We prioritize close collaboration with our customers in everything we do. Working in the QC Microbiology department involves a wide range of tasks and interactions with numerous products and customers. Unlike traditional pharmaceutical companies, the work at AGC is diverse and continuously offers new knowledge and experience. We are seeking an engaged and ambitious leader who is passionate about teamwork, has a deep understanding of Microbiology, Environmental Monitoring, and GMP biopharmaceutical production, and is dedicated to people development.

The QC Microbiology Manager position:

We are looking for a Manager for our QC Microbiology Scientists to ensure that the team thrives and meets its deliverables and goals. While you don’t need to be an expert in all listed areas, you should be able to contribute with knowledge sharing and constructive feedback for both Scientist groups on various topics. In addition to managing your team, you will be part of the QC Microbiology Management group, which includes a Team Lead, a Manager, and a Director. You will also collaborate closely with internal stakeholders such as Manufacturing, Development, QA, and other QC departments on cross-organizational activities. As the Manager of the QC Microbiology Scientist group, it is essential to create a positive, motivating, and productive working environment in accordance with AGC Biologics values.
 

Additionally, AGC Biologics in Søborg has recently opened a new facility for drug substance production, which includes new QC laboratories. We look forward to moving into this facility this year, providing you with excellent opportunities to engage in projects with various departments as part of the expansion activities. You will be responsible for ensuring compliance with cGMP and participating in customer audits and regulatory inspections, which are frequent occurrences for us as a leading CDMO. This role requires a strong GMP mindset and relevant experience. It is pivotal that you have a passion for continuous improvement and process optimization, with a focus on implementing new technologies and automation within QC Microbiology as we strive to enhance our operations.

Key Responsibilities:

• Provide leadership and guide the development of your team of scientists
• Set the team’s direction, motivate members, and prioritize tasks
• Manage and ensure that the team possesses the necessary competencies
• Guarantee that we deliver on our commitments to both customers and internal stakeholders at AGC
• Foster alignment with peers across QC/AGC Biologics and build an efficient team
• Challenge the status quo and promote a culture of continues improvement
• Ensure adherence to the required quality standards and cGMP compliance
• Proactively maintain a safe and healthy work environment with a focus on safety first
• Report progress and updates for the team to the department director

The daily challenges will be diverse, and no two days will be the same.

Your profile:

We are looking for a candidate with the following qualifications:

• A degree in science, engineering, or a related field, preferably a MSc or PhD
• Knowledge of microbiological quality control in biopharmaceutical production
• Understanding of environmental monitoring and qualification in biopharmaceutical production
• 3 years of experience in a regulated (cGMP) manufacturing environment
• Preferably 3 years of experience as a Team Leader or Manager
• Strong organizational skills to improve systems and efficiency
• Proficient in English, with excellent communication abilities to engage effectively with customers and colleagues from diverse cultural backgrounds, and the capacity to secure buy-in from all key stakeholders
• Familiarity with EMA, FDA, and ICH regulations for biologics
• A strong driver of interdepartmental tasks, skilled in keeping the end goal in focus while prioritizing multiple responsibilities
• Open-minded, curious, and motivated by your team’s success
• A can-do attitude with a solution-oriented approach and strong communication skills
• LEAN skills are an advantage

Your Application:

We will process the applications as they are received. Therefore, we encourage you to apply as soon as possible. Once we find the right candidates, the job posting will close. We look forward to receiving your application today! For further information regarding the position, please contact Susanne Vestergaard, Director, 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.