Scientist for QC Bioassay
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Søborg
Are you looking for an exciting job in an international and challenging environment? This is a great opportunity to make the most of your expertise and passion for Bioassay.
AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply. Right. On time. For more information, visit www.agcbio.com
Responsibilities and tasks
The QC department consists of three functional groups: QC Bioassay, QC Chemistry and QC Microbiology and is responsible for supporting the production of new biopharmaceuticals by running various analytical methods, executing stability programs and validating analytical procedures according to ICH guidelines.
As a Scientist in QC Bioassay you will be involved in a range of exciting tasks and challenged. You will be responsible for delivering scientifically sound and cGMP compliant analytical results and documents, planning and completing projects within deadline in close collaboration with your colleagues and assist the whole QC area with your professional expertise. Furthermore, you will work closely with scientists in other departments particularly Analytical Development and have direct contact with external customers.
Further responsibilities
• Write and review cGMP documents (e.g. method procedures)
• Review and approval of analytical results for cGMP compliance and scientific content
• Support analytical method transfers from Analytical Development or customers into QC
• Responsible for method validations according to ICH guidelines
• Represent QC at regular customer meetings in close collaboration with colleagues in Manufacturing, Process Transfer and QA.
• Drive Initial Laboratory Investigations and deviations related to QC activities
• Troubleshooting and scientific support on bioanalytical methods such as qPCR, ELISA assays, protein electrophoresis (SDS-PAGE), and protein concentration determination
Qualifications
The candidate we are looking for has:
• An master degree within life sciences
• Extensive experience, theoretical and hands-on, with qPCR method
• Experience with bioanalytical methods, e.g. ELISA and protein electrophoresis
• Good analytical and troubleshooting skills
• Experience with writing validation protocol, validation report, and method procedures
• Experience working in a GMP environment
• Good communication skills and a service-minded attitude to meet customer requests in a positive and professional way
• A person who can handle multiple tasks in a busy environment with a positive and constructive attitude
• Fluent in written and spoken English
Interested?
Submit your application as soon as possible and no later than August 15th. We treat the applications as we receive then, and conduct interviews with qualified candidates prior to deadline.
For further information regarding the position, please contact Henriette Nielsen, Sr. Manager QC Bioassay, at +45 2294 3092.
Kilde: Jobnet.dk
AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply. Right. On time. For more information, visit www.agcbio.com
Responsibilities and tasks
The QC department consists of three functional groups: QC Bioassay, QC Chemistry and QC Microbiology and is responsible for supporting the production of new biopharmaceuticals by running various analytical methods, executing stability programs and validating analytical procedures according to ICH guidelines.
As a Scientist in QC Bioassay you will be involved in a range of exciting tasks and challenged. You will be responsible for delivering scientifically sound and cGMP compliant analytical results and documents, planning and completing projects within deadline in close collaboration with your colleagues and assist the whole QC area with your professional expertise. Furthermore, you will work closely with scientists in other departments particularly Analytical Development and have direct contact with external customers.
Further responsibilities
• Write and review cGMP documents (e.g. method procedures)
• Review and approval of analytical results for cGMP compliance and scientific content
• Support analytical method transfers from Analytical Development or customers into QC
• Responsible for method validations according to ICH guidelines
• Represent QC at regular customer meetings in close collaboration with colleagues in Manufacturing, Process Transfer and QA.
• Drive Initial Laboratory Investigations and deviations related to QC activities
• Troubleshooting and scientific support on bioanalytical methods such as qPCR, ELISA assays, protein electrophoresis (SDS-PAGE), and protein concentration determination
Qualifications
The candidate we are looking for has:
• An master degree within life sciences
• Extensive experience, theoretical and hands-on, with qPCR method
• Experience with bioanalytical methods, e.g. ELISA and protein electrophoresis
• Good analytical and troubleshooting skills
• Experience with writing validation protocol, validation report, and method procedures
• Experience working in a GMP environment
• Good communication skills and a service-minded attitude to meet customer requests in a positive and professional way
• A person who can handle multiple tasks in a busy environment with a positive and constructive attitude
• Fluent in written and spoken English
Interested?
Submit your application as soon as possible and no later than August 15th. We treat the applications as we receive then, and conduct interviews with qualified candidates prior to deadline.
For further information regarding the position, please contact Henriette Nielsen, Sr. Manager QC Bioassay, at +45 2294 3092.
Kilde: Jobnet.dk
Information og data
Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 25.7.2019, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Forsker
- Søborg
- Torsdag den 15. august 2019
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