*Analytical Scientist for QC Bioassay

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Are you looking for an exciting job in a fast growing international CDMO organization producing new biological medicines? Then look no further and join us. As an Analytical Scientist in QC Bioassay, you will be involved in a broad range of tasks including release testing of products (DS/DP), method validation as well as coordination of QC deliverables in AGC projects with customers from around the globe. You will join a team of 11 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, Stability and Raw Materials). 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 4 teams, including the Bioassay Scientist team. We perform a broad range of analytical assays (e.g. ELISA’s, qPCR, 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 you will be involved in multiple different tasks all related to ensure timely release testing of product (DS/DP) for our customers. Thus you will be responsible for analytical transfer activities and validations, laboratory investigations, and compliance activities. Furthermore, you will be involved in coordination and execution of analytical activities in QC Bioassay and across the QC area. Focus will be to ensure good collaboration with and communication to multiple stakeholders both in QC, cross-functional (e.g. Analytical Development, Project Management and QA) and not least with our customers.

Your key responsibilities:

  • Review and approval of analytical results
  • Responsible for method validations according to current ICH guidelines
  • Troubleshooting and scientific support on a broad range of bioassay methods
  • Drive compliance documents related to QC activities
  • Represent QC at regular customer meetings, and support analytical method transfers into QC
  • 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 preferable 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 bioanalytical methods
  • Experience with working in a cGMP setting according to EU and US guidelines
  • Hands on experience with handling laboratory investigations, deviations and CAPA’s
  • A strong analytical mindset and a pragmatic can-do-attitude
  • 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, QC Bioassay, 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.

AGC offers a dynamic working place where exciting and challenging assignments will constantly come your way, and you will get insight into and experience with the way the various departments interact throughout a contract manufacturing organization. We aim for an informal work environment, where humor is part of the daily work life. We respect each other, individual diversities and cultures. AGC’s employees have a flexible attitude, are innovative and collaborative, working together as one team we do achieve success.

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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 19.9.2022, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Forsker
  • København
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