Technician, 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.

QC Bioassay Laboratory Technician, Temporary 12 Months

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.

We are looking for a motivated colleague to join our QC Bioassay department. As an employee in Quality control at AC Biologics in Søborg, you can look forward to a great deal of responsibility and varied work tasks. You can also look forward to being part of a good team in an open and informal environment with solid professionalism, high pace and lots of good laughs.

The Department

The QC organization (QC) consists of five departments: QC Bioassay, QC Chemistry, QC Microbiology, QC Support and QC Planning & Systems. QC is responsible for supporting production of new biopharma-ceuticals by controlling raw materials, performing analytical testing, environmental monitoring of productions rooms, planning and executing stability programs and validating analytical methods according to ICH guidelines from clinical phase I to phase III and commercial.

The position is placed in the QC Bioassay department, we are in total 48 employees, divided into five groups. We perform a broad range of compendial methods, bioassays (e.g. ELISA´s, qPCR, and SDS-PAGE), as well as cell-based assay. 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 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 and Responsibilities

As a technician in QC Bioassay, you will be involved in analytical testing of drug substance and drug product samples as well as in-process samples. Moreover, you will be involved in stability programs and validation of methods used for phase I/II and phase III/Commercial products.

Main responsibilities:

• Execute a variety of Bioanalytical methods (e.g., Solo, OD, Osmolality and Endotoxin)
• Report results including data processing in LIMS and setup.
• Participate in method validation studies.
• Participate in troubleshooting of methods.
• Participate in on-time testing of stop/go samples to support our manufacturing facility.
• All testing is performed according to the cGMP.

Qualifications

The ideal candidate holds a degree as Laboratory Technician (laborant). We expect you to have a structured mindset, be able to work independently and meet tight deadlines with a can-do attitude but without compromising the quality.

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

• Experience with performance of Bioanalytical methods and a plus if you have experience with Endotoxin testing.
• Experience working in a cGMP setting according to European and US regulatory guidelines.
• Good communication skills and a service-minded attitude as you will work closely with your stakeholders, mainly form the manufacturing.
• Has a flair for teamwork combined with the ability and desire to work independently.
• The ability to handle multiple tasks simultaneously in a busy environment.
• Fluent in written and spoken English.

Application

For further information regarding the position, please contact QC Bioassay Manager Jona Uldahl-Jessen at +45 60253361. We treat the applications as we receive them and conduct interviews with qualified candidates. Please submit your application as soon as possible. When the right candidate 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