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Experienced Analytical Scientist for HPLC and Capillary Electrophoresis Assay Development Team

AGC is looking for a Scientist with expertise with development of analytical methods for protein-based biotherapeutics We are seeking a scientist with a strong scientific profile within development of analytical techniques for protein analysis focused on HPLC and capillary electropresis techniques in the HPLC assay development team in the Analytical Development (AD) Department at AGC Biologics A/S (AGC). AGC is a Contract Manufacturing Organization with facilities in Denmark, Germany, Italy, Japan and USA and with customers all over the world.
The departmentThe AD Department is responsible for implementation, transfer and development of analytical procedures, analytical support to upstream and downstream, characterization of products, testing engineering batches for production and the transfer of analytical methods to QC for validation. AGC projects range from early pre-clinical development through all phases of clinical development all the way to commercial supply. AD is also involved in cross functional project groups and implementation of new analytical technologies and techniques.
As a scientist in the chromatographic assay development group you will be responsible for developing state of the art methods for HPLC, like SEC, IEC, RPC, HIC etc. and electrophoretic techniques, mainly cIEF and CGE but to some extend also CZE. The developed methods will be utilized for analytical support on a wide variety of protein based products to support our customers getting their product to market as fast as possible with a high quality. You will be working together with a team of 4 scientists and 6 technician’s. You will be ADs representative in customer projects, and present the excellent methods implemented as well of the results of these to our customers and provide analytical input to discussions.
As a scientist in AD with responsibility for method implementation, transfer and development, approval of analytical data, participation in cross functional project teams and interaction with customers we can promise a diverse job with a possibility to get responsibility fast.    The work environment in our department is very informal. There is constant collaboration across the organization, and all employees have a professional and flexible attitude towards their work. The department consists of 30 dedicated and highly competent scientists and technicians working in four sub team; HPLC/CE development, bioassay development, process development support and characterization. The team is in close contact with our counterparts in our Seattle facility.
Responsibilities and tasksAs a scientist, you will be responsible for multiple methods in many analytical development projects and act as AD project coordinator. You will participate in multi-disciplinary project teams including Upstream, Downstream, Process Transfer, QC, QA and Manufacturing scientists working in close collaboration with the clients’ scientific teams.
You will get the opportunity to work with a broad range of personalities as well as diverse products in different clinical stages and to use your skills in a very cross functional setting and interactive environment.
The job includes:Transfer, development and Implementation of analytical procedure within HPLC and Capillary electrophoresis (CE).

  • Representation of Analytical Development (AD) in cross-functional project teams.
  • Verbal and written reporting to clients.
  • Approval and reporting of analytical results to internal and external customers.
  • Defining product specification together with QC and the client.
  • Transfer of analytical procedures to QC.
  • Coordinating external testing.
  • Strategic technology development together with the department.


Experience and competenciesThe ideal candidate holds a PhD in Protein Chemistry, Biochemistry, Biochemical or Chemical Engineering, or related scientific/technical background with expertise in chromatographic and electrophoretic methods in a protein context. In addition to that you have:

  • Several years of experience in analytics for biologics, preferably from the biotech industry.
  • Strong expertise within development of analytical procedures.
  • Strong understanding of the workings of analytical instruments and how instrument variables affect assay performance.
  • Strong cross-functional expertise and understanding of how analytical methods best capture/monitor potential impacts to the quality and functional activity of proteins during the production process.
  • Experience with characterization assays for biologics will be an advantage.
  • An understanding of biopharmaceutical manufacturing and regulatory requirements.
  • Good interpersonal and communication skills.
  • Prior experience with leading small teams would be an advantage.
  • Excellent English written and oral communication skills.

On a personal level we expect you to:Be a high performing team player and to be ambitious on behalf of yourself and the company. You master the balance between speed of execution and quality of work. You embrace change and enjoy a rapid pace of work with a positive, can-do attitude and with a good sense of humor. You think of last minute changes as a positive variety in the daily work. You are driven by achieving results through others and are good at presenting results in a convincing manner. For further information, please contact Lasse Olsen, HPLC/CE method development Team lead, Analytical Development, phone +45 2269 9432, or Helle Grann Wendelboe, Senior Director of Analytical Development, phone +45 2294 3090.

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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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