Biopharmaceutical Development Specialist
1 week ago
At AGC Biologics, we are seeking a highly skilled Biopharmaceutical Development Specialist to join our QC Chemistry team. As a key member of this team, you will be responsible for driving PhI/II and PhIII/Commercial method validation activities, reviewing release and stability analytical set-ups, supporting lab technicians, authoring SOPs, and running Lab Investigations, Deviations/CAPAs, and CR cases.
The ideal candidate will hold a MSc or PhD degree in Biochemistry, Chemistry, or a relevant area alongside a minimum of 3 years of work experience in analytical development or quality control. Additionally, they should have one or more of the following skills:
- Working and troubleshooting experience with SE-, IEX-, and RP-UHPLC, iCIEF, and CGE-SDS analysis.
- Experience with Chromeleon software and LIMS.
- Technical experience in protein analytics testing and protein biochemistry.
- Experience in validating analytical methods according to ICH guidelines for PhI/II and/or PhIII.
- Experience working in cGMP settings according to European and US regulatory guidelines.
- Fluent in written and spoken English.
We are looking for someone with excellent communication, presentation, and interpersonal skills who can prioritize their own tasks in a dynamic environment, work independently as a team player, and bring a positive, can-do attitude and a good sense of humor.
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