Scientist, QC Chemistry
21 hours ago
Apply locations Copenhagen, Denmark time type Full time posted on Posted Yesterday job requisition id JR101392
Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.
Scientist, Analytical Validations & SME, QC Chemistry (temporary/12 months cover)
Are you motivated by leading and participating in coordination and planning of analytical QC activities and support clinical and commercial manufacturing for our Customers worldwide? Do you thrive in an international environment where teamwork and collaboration are on top of the agenda? Then we might have just the right opportunity for you
The QC Chemistry department
QC Chemistry is one of five departments in the QC area. QC Chemistry is responsible for supporting the production of new or marketed biopharmaceuticals by performing analytical testing and validating various analytical procedures according to ICH guidelines from clinical phase I to phase III and commercial. QC Chemistry have a close collaboration within the QC area and with departments across the organization as well as AGC Biologics external Customers and external vendors.
Role & responsibilities
As Scientist and Subject Matter Expert (SME) for validations in QC Chemistry, it is required that you have expertise and ability to troubleshoot on chromatographic methods, especially (U)HPLC, iCIEF and CGE-SDS. You will be driving PhI/II and PhIII/Commercial method validation activities, review release and stability analytical set-ups, support lab technicians, author SOPs and run Lab Investigations, Deviations/CAPAs and CR cases. Since you will participate in method relevant Customer meetings and provide input for validation plannings, good communication skills are essential together with a general understanding of planning and coordination of activities.
Your Profile
The ideal candidate holds a MSc or PhD degree in Biochemistry, Chemistry or other relevant area alongside a minimum of 3 years of work experience in analytical development or quality control.
Additionally, we are looking for someone with 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 with working in cGMP settings according to European and US regulatory guidelines
- Fluent in written and spoken English
... and the following characteristics:
- Excellent communication, presentation, and interpersonal skills
- You like to share your knowledge and communicate openly and professionally both internally and with external customers
- You are able to prioritize your own tasks in a dynamic environment
- You are a team player with ability to work independently
- You have a self-motivating personality with a pragmatic, solution oriented approach to the daily work, without compromising quality
- You thrive in a dynamic environment and enjoy a rapid pace of work where we all work as one team
- You bring a positive, can-do attitude and a good sense of humor
Application
Submit your application as soon as possible We treat the applications as we receive them, and conduct interviews with qualified candidates. When the right candidates are found, the ad will close.
AGC offers
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 with the way the various departments throughout a contract manufacturing organization interact to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extent 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.
About AGC Biologics
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy, and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit .
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