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 has the responsibility of critical functions, not only related to QC Bioassay but to the entire QC as well as across the organization.

Role and Responsibilities
As Manager in QC Bioassay you are managing a team of both Scientists and Technicians. You naturally create a positive and inspiring environment around you and lead by being the good example. You thrive in a fast-paced environment and have focus on delivery of results right and on time, but at the same time have focus on your employees.

The manager will report to the Director of QC Bioassay, and will be part of the Bioassay Leadership team, where support and collaboration is a natural part of the workday. Moreover, the manager will work closely together with other departments within QC as well across the organization.

Key responsibilities:

• Provide leadership and drive the development of your team
• Set direction, motivate the team and prioritize tasks
• Involved in QC Coordinator activities and training, as well as customer interactions
• Setting the strategy for Reference Material
• Establishing a Control material strategy, and ensure a continuous supply of Critical reagents through a process for timely readiness
• Oversee QC deliveries on Batch release
• Participate in customer audit and regulatory inspection of which we as leading CDMO experience a lot
• Responsible for ensuring QC Bioassay is in compliance
• Support release and stability testing in close collaboration with Managers from other QC Bioassay teams
• Focus on continuous improvements

Qualifications
The ideal candidate holds a master degree within life sciences and work experience within the pharmaceutical industry from an analytical development or Quality Control department.

In addition, we expect you to bring some of the following experiences and characteristics:

• Experience as leader, preferably from pharmaceuticals, biotech or related field
• A strong GMP mindset and experience working in a GMP environment
• Good communication skills, a service-minded attitude and the ability to build relationships with stakeholders across organization
• Knowledge within Bioassay methods
• Preferably knowledge related to controlling of reference materials
• The ability to navigate a fast-paced, environment, juggling deadlines and tasks with finesse
• Flexibility to adapt to evolving business needs and priorities
• Interest in continuous improvement and process optimization, and have focus on new technologies and automation as we continuously improve our way of working

Application
For further information regarding the position, please contact Director Henriette S. Nielsen, QC Bioassay, at +45 2294 3092. We treat the applications as we receive them and conduct interviews with qualified candidates. When the right candidates are found the add will close.

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