Manager in QC Bioassay

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.

Do you want to set the direction and drive the development of our new QC Bioassay team. Do you like to motivate and inspire, and have the flair prioritizing between constantly shifting priorities?
QC Bioassay is looking for a Manager for one of our QC Bioassay teams, a great team of highly skilled and dedicated QC Scientists and Technicians.

AGC Biologics A/S is a global CDMO organization producing biological medicines for both clinical testing and marketing. We are working in an international and customer-oriented way to secure fast and reliable manufacturing of medicines to our customers. Since we are a contract manufacturing organization, a high level of service to our clients is in focus.

At AGC Biologics, you will get a unique opportunity working with a variety of different state of the art technologies among +40 different nationalities. This opens many doors for personal development and for you to make a real difference towards both patients, and customers. AGC offers an informal and friendly working environment, characterized by the fact that we think it is fun to go to work. We respect each other and our differences. AGC employees are flexible and take pride in working together to achieve goals - as one team.

The Department

Quality Control (QC) consists of approximately 150 employees divided into three testing departments and two support departments. In QC we are responsible for supporting production of biopharmaceuticals by controlling raw materials, performing analytical testing, environmental monitoring, executing stability programs and validating analytical methods. Finally, but not least we are responsible for supporting the 24/7 operating manufacturing of biopharmaceuticals by testing of in-process stop/go samples.

The vacant position is placed on QC Bioassay, a department of 48 employees, both scientists and technicians, divided into five groups. As we expand, a new QC Bioassay team will be established, which the responsibility of critical functions, not only has related to QC Bioassay but to the entire QC as well as across the organization.

Role and Responsibilities

As a Team Lead or Associate Manager in QC Bioassay, you will lead a small team of Scientists and Technicians. You will foster a positive and inspiring environment, setting a strong example for your team. You thrive in a fast-paced setting, focusing on timely and accurate results while prioritizing employee development.

This role reports to the Director of QC Bioassay and is part of the Bioassay Leadership team, where support and collaboration are integral to daily operations. You will also work closely with other QC departments and across the organization.

Key Responsibilities:

• Provide leadership and support the development of your team.

• Set direction, motivate team members, and prioritize tasks.

• Engage in activities and training, as well as customer interactions.

• Develop strategies for Reference Materials and establish a Control Material strategy to ensure a continuous supply of Critical Reagents.

• Oversee QC deliveries for Batch Release.

• Participate in customer audits and regulatory inspections, leveraging our experience as a leading CDMO.

• Ensure QC Bioassay compliance with relevant regulations.

• Collaborate with Managers from other QC Bioassay teams on release and stability testing.

• Focus on continuous improvements.

Qualifications

The ideal candidate holds a master’s degree in life sciences and has relevant work experience in the pharmaceutical industry, particularly within analytical development or Quality Control.

We welcome candidates with the following experiences and characteristics:

• Leadership experience, such as in a Team Lead, Principal Scientist or Coordinator role, preferably in pharmaceuticals, biotech, or a related field.

• GMP mindset and, preferably, experience working in a GMP environment.

• Excellent communication skills and a service-oriented attitude, with the ability to build relationships across the organization.

• Knowledge of Bioassay methods and, ideally, experience in managing reference materials.

• Ability to navigate a fast-paced environment, juggling deadlines and tasks effectively.

• Flexibility to adapt to evolving business needs and priorities.

• Interest in continuous improvement, process optimization, and new technologies, including automation.

Application

For further information regarding the position, please contact Gitte Damgaard, QC Director Bioassay, at +45 3077 4209. We treat applications as they are received and conduct interviews with qualified candidates.

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.

Location: Copenhagen Site