Manager, QC Bioassay (12 months maternity cover)

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 direction for the Cell, ELISA & Reference Material team in QC Bioassay? As our new temporary manager, you will help us develop and manufacture safe and sustainable biopharmaceutical products that improve lives around the world.

The QC Bioassay Department:
The vacant position is placed in QC Bioassay which is one out of five departments in our QC Organization. In QC Bioassay we are in total 48 employees, both scientists and technicians, divided into four teams; Bioassay Scientists, Bioassay Technicians, Bioassay Cell, ELISA & Reference Materials (RM), and General Analytics. QC Bioassay perform a broad range of compendial methods, bioassays, as well as cell-based assays. We are responsible for method validations for early and late-stage products, release testing of clinical and commercial batches (DS and DP) as well as testing of stability study samples. Finally, but not least we are responsible for supporting the 24/7 operating manufacturing of biopharmaceuticals by testing of in-process stop/go samples.

Role & Responsibilities:
As Manager for QC Cell, ELISA & RM you will be managing a team of 5 Scientists and 5 Technicians. The team is performing batch release (DS and DP), testing of stability study samples, & analytical method validations. Management of reference materials for all QC is also placed in the team.

The Manager will report to the Director of QC Bioassay, Gitte Damgaard, and will be part of the Bioassay Leadership team.

Key responsibilities:

• People management.
• Operational planning.
• Ensure all activities are following cGMP and performed in a safe working environment.
• Continuous improvement of laboratory workflow to reduce the turn-around-time for analytical samples results.
• Communication with relevant stakeholders.
• Support regulatory inspections and customer audits.

Your profile:
The ideal candidate holds a master’s degree within life sciences and 2-3 years of work experience within the pharmaceutical industry working in a GMP environment. In addition, we expect you to bring some of the following experiences and characteristics:

• Experience as people manager or proven skills to develop into this role.
• Experience working in a GMP environment and knowledge of relevant guidelines.
• You have a quality and structured mindset.
• You possess good communication skills, have a service-minded attitude, and the ability to effectively communicate with others.
• Strong decision maker and ‘can-do’ attitude
• The ability to handle multiple tasks simultaneously in a busy environment.
• Able to quickly obtain the overview of multiple tasks in challenged situations, can prioritize and make quick and qualified decisions.
• Experience and knowledge of ELISA methods, Cell based assays and method validations will be an advantage.

Your Application:
Apply today! We treat the applications as we receive them and conduct interviews with qualified candidates. When the right candidates are found, the add will close. For further information regarding the position, please contact Director Gitte Damgaard, QC Bioassay, at gdamgaard@agcbio.com.

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