QC Bioassay are looking for a dedicated, professional, enthusiastic colleague who is passionate about equipment’s. Do you thrive in a dynamic environment, in a department with skilled colleagues – you might be our new Equipment Scientist in QC Bioassay.
At AGC Biologics A/S, we work with the development of biopharmaceutical manufacturing processes and GMP manufacturing of biopharmaceutical proteins for both clinical testing and marketing. Since we are a contract manufacturing organization, a high level of service to our clients is in focus. QC Bioassay is one of six departments in the QC area, where we are responsible for supporting the production of new biopharmaceuticals by performing analytical testing of samples from the production and stability programs and validating various analytical procedures according to ICH guidelines from clinical phase I/II to phase III and commercial. Within this broad working area and with various biopharmaceuticals, the QC area have a close collaboration with all departments across the organization.
- You will be ensuring that new analytical equipment for our new facility is purchased and qualified in due time to allow expansion of our analytical capacity.
- You will be authoring URSs, VPLs and VRPs.
- You are familiar with and understand the context of URS, IQ, OQ, and PQ.
- Your primary scope is procurement and qualification of bioassay methods includes ELISA, LAL readers, Octet, SoloVPE, qPCR, instruments etc. Furthermore, you will also be responsible for other types of equipment like LAF-benches, water baths, balances etc.
The position requires hands-on experience with instrument maintenance. All work in the department is performed under cGMP and you will be responsible for performing the maintenance experiments, finalizing service reports and enter work performed in the equipment database.
In collaboration with equipment group in QC Bioassay you will be responsible for completion of all qualifications and maintenance activities within deadlines.
The ideal candidate holds an MSc or PhD degree in Bioassays, Molecular biology or relevant area and has minimum 5 years of work experience in analytical development or quality control. In addition, we expect you to bring knowledge on equipment qualification from the pharmaceutical industry.
In addition, we expect you to have:
- Technical understanding of instruments related to bioanalytical methods (e.g. ELISA readers, qPCR instruments, SoloVPE, LAF-benches)
- Experience with working in cGMP settings according to European and US regulatory guidelines
- Experience in writing of Change Controls, URS, IQ/OQ documents and SOP´s related to analytical equipment is an advantage
- You are able to prioritize your own tasks in a dynamic environment
- You are a team player, but work independently
- Good communication and interpersonal skills
- Ability to interact positively within a team and in close collaboration with other working areas when needed
It is important to have a self-motivating personality with a pragmatic attitude and approach to the daily work - without compromising quality. Furthermore, you thrive in a challenging and dynamic environment and enjoy a rapid pace of work. You bring a positive, can-do attitude and a good sense of humor.
Submit your application as soon as possible. We treat the applications as we receive then, and conduct interviews with qualified candidates. When the right candidates are found, the add will close.
For further information regarding the position, please contact Manager Anne Lykkegaard Widlund, QC Bioassay Cell and support, at +45 2760 2154
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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.
Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.