Join a dynamic and international company where everyone is responsible for delivering right on time as one team!

AGC Biologics is an international and modern organization with production sites in Europe, Japan and US. AGC Biologics is the largest contract development and manufacturing organization (CDMO) in the world and currently AGC Biologics, employee’s more than 800 people worldwide where app. 600 are situated in Denmark close to Copenhagen. AGC Biologics delivers biopharmaceutical development and manufacturing of Drug Bulk Intermediates/Active Pharmaceutical Ingredients for both clinical studies as well as for the global market.

The Department
QC Chemistry is part of the QC organization which consists of six departments: QC Bioassay, QC Chemistry, QC Microbiology, QC Adjuvant, QC Stability and QC Raw Materials. QC is responsible for supporting the production of various biopharmaceuticals by controlling raw materials, performing analytical testing, planning and executing stability programs and validating analytical methods according to regulatory guidelines from clinical phase I through phase III and commercial

We are looking for a new colleague to join our QC Raw Materials team, which consists of 8 skilled colleagues, represented by scientists, technicians, and a Team Lead.

The Position
QC Raw Material is covering the daily release testing flow of Raw Material and driving our Raw Material Qualification and Release Testing program for late stage projects. As part of daily release flow, the scientist position cover test planning of incoming raw materials, keeping Raw material specifications in compliance, assessing Supplier Change Notifications, as well as providing scientific solutions to contract labs.

Key responsibilities:

  • Writing and maintaining raw material specification based on European or US regulatory guidelines as well as adapting to supplier change notifications
  • Deliverance of scientifically sound and cGMP compliant raw material documents and analytical results. Involvement in operating the raw material program, including risk assessments and creating qualification protocol/reports
  • Oversight of sampling, as well internal as outsourced testing.
The Profile
The ideal candidate holds an MSc or PhD degree in Chemistry, Pharmacy or relevant area and has subsequently obtained minimum 3 years of work experience within quality control or quality assurance. In addition, we expect you to bring some of the following experience and characteristics
  • Profound writing and reviewing skills of cGMP documents: raw material specifications, test methods, general procedures
  • Experience setting specifications for compendial and non-compendial raw materials
  • Indebt understanding of US and European pharmacopoeias
  • Experience handling change controls, deviations and CAPAs
  • You are an experienced multi-tasker and you enjoy working in a high pace and be challenged in a busy business
  • You are a team player combined with the ability and desire to work independently
  • Experience with FT-NIR analysis of raw materials is an advantage.

AGC has international customers and our company language is English. It is therefore vital to be fluent in written and spoken English

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
Submit your application as soon as possible. We treat the applications as we receive then, and conduct interviews with qualified candidates. When the right candidates are found, the ad will close.

If you have further questions, please contact Christina Mernoee Jensen,Team Lead, QC Raw Materials, phone +45 4137 7902.

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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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