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In QC Chemistry, we are looking for a (Principal) Technician to support testing of samples for stability studies, batch release, method validations and support our manufacturing facility by testing ´stop/go´ samples. You will be involved in a broad range of critical tasks supporting timely deliverables and with high impact in AGC Biologics customer Projects all over the world. As our new colleague, you will join a team of 12 technicians and report to the Team Lead of the QC Chemistry Technician Team.
About The Department:
The QC Chemistry department is part of the Quality Control organization in AGC Biologics CPH, which consists of around 160 dedicated and skilled colleagues divided into five departments (QC Chemistry, QC Bioassay, QC Support, QC Microbiology and QC Planning & Systems). Together we use our technical and scientific expertise as we work side by side with our customers, securing timely delivery of reliable and compliant products for patients.
QC Chemistry Technician Team is a part of the QC Chemistry department, which consists of 10 dedicated Scientists, 13 laboratory Technicians and three leaders. As technician in QC Chemistry, you will be responsible for performing chromatographic analysis such as RP-UHPLC, SE-UHPLC, HIC-UHPLC, cIEX-UHPLC, peptide mapping, CE-SDS and iCIEF.
The department is situated on Vandtårnsvej in Søborg, Greater Copenhagen Area, with plans for moving the lab to a new, neighboring facility during 2024.
Roles And Responsibilities:
As a laboratory technician in QC Chemistry you will be responsible for performing timely analyzes for manufacturing of DS and stability studies of DS and DP, ´Stop/Go´ manufacturing samples as well as validation of analytical methods for clinical phase I/II, phase III and products for Market. Support to troubleshooting and guidance for customers is a natural part of the job, as is supporting a professional environment during customer audits and Health Authority inspections.
All your work must be performed under cGMP and you will be a part of ensuring that existing procedures and guidelines are followed in AGC Biologics CPH QC.
In the daily work, your main tasks will be:
- Ensure on-time testing of samples for Batch release and Stability studies
- Support validation of analytical methods
- Ensure on-time testing of stop/go samples to support our manufacturing facility
- Troubleshooting and customer support
- Working according to cGMP Guidelines.
Skills and Competencies
The ideal candidate holds a degree as laboratory technician (laborant) or equivalent with 5+ years of relevant work experience in regulated industries. We expect you to have a structured mindset, be able to work both independently and in a team, and meet tight deadlines with a can-do attitude without compromising quality.
Furthermore it is required that you have:
- Technical experience in (U)HPLC analysis and preferably also experience with iCIEF and/or CE-SDS analysis
- Preferred experience with working in cGMP settings according to European and US regulatory guidelines
- Fluent in written and spoken English
- Good communication and interpersonal skills
- Ability to interact positively within a team and in close collaboration with other stakeholder areas when needed
You thrive in a challenging and dynamic environment and enjoy a rapid pace of work. You bring a positive, can-do attitude and have a good sense of humor along with cultural and interpersonal understanding.
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 in order to achieve success. Exciting and challenging assignments will constantly come your way and you will to a large extend 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.
Application
We continuously evaluate incoming applications and conduct interviews accordingly. Therefore, please submit your application and CV as soon as possible. When the right candidates are found, the ad will close. If you have questions about the position, please feel free to contact Team Lead Tore Linde, telephone +45 2294 3021 for further information about the position.
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 "Laborant", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 5.1.2024, men kan have været deaktiveret og genaktiveret igen.
- Laborant
- København
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