*QC Bioassay Scientist
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In QC Bioassay we are looking for a Scientist to take ownership of our Inventory of Critical Reagents used in multiple different Bioassay, as well as Control material. As Scientist in QC Bioassay, you will be involved in a broad range of tasks to supporting timely QC deliverables in AGC projects with customers from around the globe. You will join a team of 12 scientists and report to the Manager of the QC Bioassay Scientist team.
About the department
QC Bioassay is part of the Copenhagen based Quality Control organization, which consists of around 150 dedicated and skilled colleagues divided into five departments (Bioassay, Chemistry, Microbiology, Support and Equipment & Planning). Together, as one department we use our technical expertise when working side by side with customers, to provide innovative solutions to secure timely delivery of reliable and compliant products for patients.
In QC Bioassay, we are a group of dedicated scientists and technicians divided into 3 teams, including the Bioassay Scientist team. We perform a broad range of analytical assays (e.g. ELISA’s, Octet-based methods, SDS-PAGE and different pharmacopeia methods). The department is responsible for diverse tasks such as analytical method validation, batch release testing and stability testing of phase I/II and phase III/Commercial products (DS/DP), as well as coordination and planning of analytical activities and troubleshooting; All to support our customers.
Roles and Responsibilities
In the vacant scientist position your primary responsibilities will be focused on our critical reagents and control materials. You are expected to take ownership of the inventory management control and in close collaboration with technician ensure all bridging studies are performed in a timely manner. Likewise you will take lead to ensure we are constantly in a state-of-control with regards to control charts for our Bioassay methods. You will be responsible for the required compliance documents as well as the review of analytical data and troubleshooting.
Moreover, you will be involved in the routine review and approval of analytical results to support the release of drug substance and drug products for our customers.
Since we are continuously supporting the manufacturing production, the scientist will be included in our on-call team responsible for support on review and approval of results outside normal working hours.
Your key responsibilities
- Ensure on-time delivery of bridging reports for critical reagents, mainly used for ELISA and Octet-based methods
- Create a procedure for our control material, ensure inventory management control
- On-time creation of control charts
- Review and approval of analytical results
- Troubleshooting and scientific support on a broad range of bioassay methods
- Drive compliance documents related to QC activities
- Involved in coordination and execution of analytical activities in QC Bioassay and across the QC area.
- Collaboration with multiple stakeholders, including Analytical Development, Project Managers and QA
- Ensuring all tasks performed in cGMP compliance
Your Profile
The ideal candidate holds a MSC or PhD degree in Biochemistry, Biology, Engineering or other related field of study, and has preferable experience from the Pharma industry from Quality Control, Production or CMC areas.
We expect that you thrive working in a dynamic environment and able to keep the overview of multiple simultaneous tasks also when priorities are frequently changing. Moreover, we expect you bring some of the following characteristics and capabilities:
- Experience with ELISA methods
- A strong analytical mindset and troubleshooting skills
- Structures and detailed oriented but also demonstrate a pragmatic can-do-attitude
- Hands on experience with handling laboratory investigations, deviations and CAPA’s
- Good communication skills and a service-minded attitude to meet customer requests in a positive and professional way
- Fluency in English is a requirement as English is our corporate language
Application
For further information regarding the position, please contact Director Henriette S. Nielsen, at +45 2294 3092. We treat the applications as we receive, and conduct interviews with qualified candidates. Therefore, please submit your application as soon as possible. When the right candidates are found, the add will close.
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 16.12.2022, men kan have været deaktiveret og genaktiveret igen.
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