*QC Scientist for Cell-based assay
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Are you looking for an exciting job in an international and challenging environment and want to take part in the cell-based assays journey. Then join our fantastic team as scientist in the Cell based assay group in QC Bioassay Cell and Reference material.
The Department
The QC organization consists of five departments: QC Bioassay, QC Chemistry, QC Microbiology, QC support and QC planning & systems. QC are responsible for release testing of clinical and commercial batches, and validation of the analytical methods, as well as analysis of raw materials and stability programs. We are working in an international and customer-oriented way to secure fast and reliable manufacturing of medicines to our customers.
The current position in located in QC Bioassay in the Cell and Reference material group, in Søborg, Denmark. QC Bioassay Cell and Reference material is one of four departments in the QC Bioassay area. QC Bioassay Cell and Reference material is responsible for supporting the production of new biopharmaceuticals by performing analytical testing and validating various analytical procedures according to ICH guidelines and regulatory bodies from clinical phase I to commercial. QC Bioassay Cell and Reference material have a close collaboration within the QC area and with department across the organization.
Roles and responsibilities
As a cell-based assay scientist you will be a part of a dedicated team with highly competent colleagues focusing on cell based assays. You will be involved in multi-disciplinary projects working in close collaboration with team members and/or in project groups across the QC Bioassay Cell based assays groups responsibilities.
As subject matter expert within cell-based assays, you will:
- Review/approve release and stability analyzes
- Support laboratory technicians on a daily basis
- Documenting validation activities of analytical methods related to cell bases assays for clinical phase I/II and III/commercial products
- Perform root cause investigation by deviation, CAPA´s and change requests
- Collaboration with multiple stakeholders including QC Scientists, Project Managers, QA, as well as the Customers
- Ensure compliance with cGMP
- Key player during regulatory inspections and customer audits
- Document work accurately, clearly, and in compliance with client’s requirements
- Be able to utilize new knowledge quickly and have good communication skills
Your profile
The ideal candidate holds an MSc or PhD degree in Cell Biology, Medicinal Biology, Molecular biology or other relevant area and has minimum 3-5 years of work experience in analytical development or quality control. Preferably, a background in cell-based assays. In addition, we expect you bring some of the following experience and characteristics:
- Experience with cell based assays
- Flexible and willing to take on responsibility
- Motivated by working in a dynamic environment
- Manage multiple projects based on priority
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive go-to attitude
- Fluent in English with both verbal and written communication skills
- Experience with working in cGMP settings according to European and US regulatory guidelines
Join an international and agile organization
At AGC, you will get great opportunities to work with a wide array of tasks and challenges, and you will get experience with our various departments. Furthermore, as we plan projects and tasks together in the team, you will get the opportunity to influence your daily work. AGC offers an informal working environment where high energy and enthusiasm is part of the daily work life. We respect each other and our individual differences. At AGC, we have a flexible attitude, and we help each other reach deadlines as a team.
Contact and application
For any further questions, you are more than welcome to contact Manager Anne Lykkegaard Widlund phone 27602154 [email protected]. Please be aware that we take in consideration only the applications send via our career page and, not via email. We will process the applications as they arrive.
Want to keep posted about our growth and to learn more about our company?
We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !
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.
Information og data
Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 14.11.2023, men kan have været deaktiveret og genaktiveret igen.
- Forsker
- København
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