The QC area at AGC Biologics is looking for a new colleague. The area consist of three departments: QC Bioassay, QC Chemistry, and QC Microbiology. The departments are responsible for supporting the production of new biopharmaceuticals by running various analytical methods, planning and executing stability programs and validating analytical procedures according to ICH guidelines. We work according to cGMP and AGC Biologics holds exciting customer projects from Phase I to Commercial stages.
Tasks and Responsibilities
As a Scientist in QC Bioassay, you will be responsible for delivering scientifically sound and cGMP compliant analytical results and documents, plan and complete projects within deadline in close collaboration with your colleagues and assist the whole QC area with your professional expertise. You will also have direct contact with external customers and represent QC at regular customer meetings. You will work closely with scientists in other analytical departments in particular in Analytical Development. As Scientist and QC coordinator in various customer projects you will also have close collaboration with colleagues in Manufacturing, Process Transfer and QA.
The main tasks are as follows:
• Write and review cGMP documents (e.g. test methods, general procedures)
• Review and approve analytical results for cGMP compliance and scientific content
• Assist in analytical methods transfer from Analytical Development or customers into QC
• Plan and supervise method validations according to ICH guidelines
• Represent Quality Control in customer projects (QC project coordinator) including presenting data, activity status and solutions to customers
• Drive Initial Laboratory Investigations and deviation reports related to QC activities
• Troubleshooting and scientific support in bioanalytical methods such as ELISA assays (quantitative and potency assays), protein electrophoresis (SDS-PAGE, IEF), protein concentration determination and qPCR
Ideal Candidate Profile
You hold an academic degree in Biochemistry or other related fields, practical and theoretical knowledge of bioanalytical techniques such as ELISA, qPCR and protein electrophoresis (SDS-PAGE, IEF). 3-5 years of industrial experience from a cGMP environment is a plus.
In addition, we expect you to bring some of the following experiences and characteristics:
• A flexible, dynamic and excellent team player who is fluent in English
• Good communication skills and the ability to ensure and maintain solid cross-functional collaborations
• Good analytical and troubleshooting skills
• A service-minded attitude to meet customer requests in a positive and professional way
• Focus on meeting deadlines while ensuring high quality
• A person with a good sense of humor who can plan and accomplish your work independently and efficiently.
• A person who can handle multiple tasks in a busy environment with a positive and constructive attitude.
AGC offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges. You will get insight into and experience the way the various departments throughout a Contract Manufacturing Organization interact in order to achieve success. Exciting and challenging assignments will constantly come your way and you will, to a large extend, be able to plan your daily work yourself. AGC offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC’s employees have a flexible attitude and we help each other to reach deadlines together as one team.
AGCBiologics (AGC) is a global Contract Manufacturing Organization (CMO) with biomanufacturing facilities in Europe, Japan 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.
AGCBiologics also offers non-exclusive license to CHEF1™, a proprietary CHO cell line development platform. CHEF1 delivers stable, high-titer, production-quality cell lines in optimized time frames. It is the foundation of CMC Biologics’ innovative approach to cell line and process development.
Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.
For further information regarding the position, please do not hesitate to contact Sofie Boeck, Manager QC Bioassay, mail: email@example.com
Phone: +45 2294 3092
We will process the applications as they arrive. Therefore, please submit your application and CV as soon as possible and no later than December 10. 2018.