Join a dynamic and international company that produces new biological medicines and where everyone is responsible for delivering right on time as one team!

We are looking for skilled analytical coordinators in Quality Control (QC) to take the lead on coordination of key activities and ensure critical deliverables across Quality Control.

About the department
You will join QC consisting of six departments and 120 dedicated colleagues. The departments are Microbiology, Bioassay, Chemistry, Raw Materials, Adjuvant and Stability. We are responsible for method validations for early and late stage products, release analysis of clinical batches as well as commercial and not least 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.
 
The job
To succeed in the job, you thrive in a fast-paced environment. You have a strong desire to create structure and maintain a cool overview, drive activities forward, while ensuring excellent stakeholder relations. You naturally create a positive and inspiring environment around you and lead by being the good example.

The main responsibilities are

  • Responsible QC representative for specific projects towards customers and internal stakeholders
  • Oversee and contribute to developing the analytical strategies, e.g., the control strategy and the reference materials strategy
  • Manage internal as well as outsourced activities e.g., validation of analytical procedures, testing for batch release and stability programs
  • Preparation of the analytical parts of the documentation for the authorities
  • Act as subject matter expert for QC in the core project team
  • Act as project SME during audits and inspections

As Analytical Coordinator you

  • Work in close collaboration across the QC department to ensure analytical strategies are made operational
  • Partner with department heads and specialists to ensure planning and transparent prioritization
  • Act as cross-organizational collaborator, barrier breaker and facilitator who is willing to drive change
  • Are visible across the departments and knowledgeable about ongoing activities
  • Possess the ability to see how the parts connect to the whole and respond cross-functionally to meet production and business goals, quality standards and company values.
  • Keep the bigger picture in mind at all times, yet you understand the importance of minding the details.

The ideal candidate is expected to:

  • Be a proactive self-starter and work independently.
  • Act as a strong collaborator with a positive and enthusiastic mindset.
  • Be structured in your approach to tasks, and you are skilled within project coordination.
  • Prioritize and organize work assignments and processes in a lean manner, both independently as well as in teams
  • Be highly motivated to see processes be executed smoothly and timely
  • Thrive in a busy and diverse working environment.

You have a relevant Master’s degree within pharmaceuticals, biologics or similar.

You have several years of experience from the pharmaceutical industry within analytical development or Quality Control and preferably from another functional area such as manufacturing or QA.

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.

For further information regarding the position, please do not hesitate to contact Senior Director Casper Berg, telephone +45 41377913. We process the applications as we receive them. Please submit your CV and application as soon as possible and not later than October 15.

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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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