Senior Technician, Quality Control

AGC Biologics, Inc.; København; On-site; DKK 420,000 - 600,000; Full time

Job summary

AGC Biologics in Denmark seeks a Senior Laboratory Technician to join QC Bioassay, performing analytical testing of drug substance, drug product and in-process samples. The role involves method validation support, data processing in LIMS, and contributing to stability programs to ensure release quality.

Based on our Søborg facility, this on-site position requires a strong background in ELISA or related bioanalytical methods, with a focus on accuracy, speed, and cross-functional collaboration in

Qualifications

• Degree as laboratory technician (laborant)
• Experience with ELISA strongly preferred
• Familiarity with cell-based assays is advantageous
• Fluent in English, both written and spoken

Responsibilities

• Perform analytical testing of drug substance and drug product samples
• Conduct in-process and stability testing as part of QC Bioassay
• Support method validation, troubleshooting and timely stop/go testing
• Process data and report results using LIMS and other QC systems

Skills

ELISA

Cell-based assays

Bioanalytical methods

LIMS data processing

Education

Laboratory technician degree (laborant)

Tools

LIMS

Job description

Senior Technician, Quality ControlWe use cookies to make the safest and most effective website possible.# AGC Biologics## Senior Technician, Quality ControlApply: Copenhagen, Denmark: Full time: Posted Yesterday: JR103191**Senior Laboratory Technician (Laborant), 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 is growing! Now is your chance to become Senior Laboratory Technician! Read more about AGC Biologics, QC and the roles below - if you are still intrigued by the opportunity, don't hesitate to apply today!** We are offering a permanent 37-hour positions as Senior Laboratory Technicians in a well-functioning QC Bioassay team with an informal work environment, close collaboration, and the opportunity to gain broad insight into how a bioassay department operates within an international contract manufacturing organization (CDMO). The roles are based on site in our facility in Søborg, and together with your colleagues, you will be covering the daily lab work and a weekend shift once or twice a month, depending on the schedules. The positions also require availability for Stop'n Go on-call phone duties to support manufacturing activities. **Join a big & international QC organization!** QC Bioassay is one of five departments in our big QC Organization. In QC Bioassay we are in total 51 highly skilled employees: Scientists and Technicians. QC Bioassay is divided into four groups: Bioassay Technicians, Bioassay Scientists, Bioassay Cell & Reference Material, 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 samples. Finally, but not least, we are responsible for supporting the 24/7 operating manufacturing of biopharmaceuticals by testing in-process stop/go samples.We hope this introduction gives you a flavor of the great purpose and significant responsibilities that drive our dedicated QC colleagues every day. We are not just a big but also an international and diverse group of people delivering based on cross-collaboration and support, especially of new colleagues like you. You will be working in spacious, well-equipped laboratories, with opportunities to develop your expertise as a specialist while gaining experience with other analytical methods. **Are you passionate about bioanalytical methods, like ELISA?** As a Senior Technician in QC Bioassay, you will quickly be involved in our 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.This role fits well with someone who is passionate about executing a variety of Bioanalytical methods (e.g., ELISA, Octet, qPCR and cell-based assays), as this will be your main responsibility. You will be reporting results, including data processing in LIMS and setup. Further, your tasks will include participating in method validation studies, troubleshooting of methods and on-time testing of stop/go samples to support our manufacturing facility. **Your degree as laboratory technician comes well into play with us!** The ideal candidate holds a degree as laboratory technician (laborant). All our testing is performed according to the cGMP, so your understanding and experience of this is highly appreciated. Hands-on experience with ELISA is a strong advantage for this role, and experience with cell-based assays is also appreciated. However, we also welcome applications from candidates with a relevant laboratory background and an interest in developing their skills within these methods. Our corporate language is English, so you must be fluent both in spoken and written form. In order to deliver a high level of quality, your structured mindset will be key to achieve this, but in a fast-paced environment like ours the priorities may change, so our new colleagues will thrive the best if they have a positive attitude to tight deadlines and adjusting to the new priorities without compromising on quality. Being adaptable and resilient when plans change, including handling unexpected adjustments and replanning of activities, is important in this role. Often, good communication skills and a service-minded attitude get you far here, so we appreciate your ability to ensure a positive cross-collaboration both within QC and with your stakeholders, mainly from manufacturing. **Apply today and join a dedicated and diverse QC team!**Does this sound like your next career step? Apply today, only with your CV! We will review applications and conduct interviews on an ongoing basis. The ad will close once the right candidates have been found.**Who We Are** *AGC Biologics is a global Contract Development and Manufacturing Organization with a strong presence in Denmark. From our Søborg site, we develop and manufacture life‐changing advanced biologics for some of the world’s most innovative pharmaceutical companies. Together with our team members across Europe, the U.S., and Japan, we deliver development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells therapies. Across our global network, we are united by one mission: To work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.*