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.

Manager for QC General Analytics - Evening/Night

Do you want to set the direction for our QC General Analytics team? If you are an experienced leader or want to take the next step in your career, then come and join us ensuring continuous QC support for the 24/7 operating manufacturing.

AGC Biologics A/S is a global CDMO, where we work with the development of biopharmaceutical manufacturing processes and GMP manufacturing of biopharmaceutical proteins 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.

The 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 five groups - Bioassay Scientists, Bioassay Technicians, Bioassay Cell & ELISA, Bioassay Reference and Critical materials, and General Analytics.
We 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.

QC General Analytics is organized to support the in-process stop/go testing ‘outside normal working hours’, i.e. evenings/nights, both on weekdays and weekends. The stop/go support is mainly protein measurements using OD280/SoloVPE but will soon expand to also include HPLC methods. Beside this, the team is responsible for all release and stability testing and method validations of compendial methods such as Osmolality and pH, as well as OD280/SoloVPE methods.

Role and Responsibilities

As Manager for QC General Analytics you will be managing a team of 3 scientists and 6 technicians working ‘outside normal working hours’ covering the period between 16:00 – 06:00, all seven days a week.

You will need to be flexible in regarding to working hours but will overall be able to design your own working scheme. The main focus is for you to ensure the daily people management, including planning, coaching and development, of your team, but also ensuring a close interaction with your colleagues in the Bioassay leadership team as well as other stakeholders.

The manager will report into the Director of QC Bioassay, and will be part of the Bioassay Leadership team.

Key responsibilities:

• People management of a team working ‘outside normal working hours’.
• Operational planning.
• Ensure all activities are in compliance with 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.

Qualifications
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 1st line manager or proven skills to develop into this role
• Experience working in a GMP environment and knowledge of relevant guidelines
• Has a quality and structured mindset
• Good communication skills, 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

Application
For further information regarding the position, please contact Director Gitte Damgaard, QC Bioassay, at +45 30774209. We treat the applications as we receive them, and conduct interviews with qualified candidates. When the right candidates are found, the add will close.

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 into 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, but you will to a large extent be able to plan your daily work on your own. AGC Biologics offers an informal working environment, 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 help each other to reach deadlines together as one team, in accordance with our slogan - Right. On Time.

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