Are you looking for an exciting job in an international company producing new biological medicines? Do you want to work in a dynamic environment together with skilled colleagues and in an organization where everyone is responsible for delivering right-on-time as one team?

Quality Control, Bioassay is looking for a Scientist/Principal Scientist to be part of our team.

About the department
Bioassay is part of the Quality Control (QC) organization which consists of 120 dedicated colleagues in six departments: Bioassay, Chemistry, Microbiology, Adjuvant, Stability and Raw Materials . We are responsible for method validations for early and late stage products, release analysis of clinical batches as well as commercial as well as analysis of raw materials and stability programs. We are working in an international and customer oriented way to secure fast and reliable manufacturing of medicines to our customers.
 
Role and Responsibilities
As Scientist/Principal Scientist in Bioassay you are expected to have the solid scientific and technical knowledge and understanding of bioanalytical methods. You are familiar with compliance guidance ensuring delivery of scientifically sound and cGMP compliant analytical results and documents.

You will be involved in a wide range of exciting tasks and challenges, where you are expected to take ownership ensuring delivery within deadlines:

  • 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 as well as have direct contact with external customers
  • Ensuring all tasks performed in cGMP compliance
Qualifications
The ideal candidate holds a master degree within life sciences and work experience within the pharmaceutical industry preferable from an analytical development or Quality Control.

In addition, we expect you to bring the following experience and characteristics:

  • Experience, theoretical and hands-on, with bioanalytical methods
  • Good analytical and troubleshooting skills
  • Experience working in a GMP environment and knowledge of relevant guidelines
  • Good communication skills and a service-minded attitude to meet customer requests in a positive and professional way
  • Thrive in a fast-paced environment, able to handle mulitple tasks simultaneously

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 then, and conduct interviews with qualified candidates. When the right candidates are found, the add will close.

AGC offers
AGC offers a dynamic working place with good opportunities of working with a varied array of manufacturing 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 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.

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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.
 
 

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