Scientist – Quality Control – Environmental monitoring and Microbiology

The Department

The QC department at AGC Biologics consists of: QC Bioassay, QC Chemistry, QC Microbiology, QC Raw Materials and QC Stability. QC are responsible for environmental monitoring of production rooms, supporting production of new biopharmaceuticals by controlling raw materials, performing analytical testing, planning and executing stability programs and validating various analytical methods according to ICH guidelines from clinical phase I to phase III and commercial.

The vacant position is so far a temporary scientist for 12 months in QC Microbiology department (consisting of 12 highly dedicated technicians, 6 skilled scientists, a team lead and a manager). QC Microbiology is responsible for environmental monitoring (EM) in clean rooms (production rooms), re-/qualification, chemical/ microbiological analyses on pharmaceutical water and TOC analysis on rinse samples from production further microbiological analysis on batches for clinical and commercial samples and method validation.

The department works in close collaboration with Manufacturing, Quality Assurance, Up- and Downstream Development, Analytical Development and external laboratories to maintain control of all steps in the manufacturing processes. Everything we do, we do in close collaboration with our customers

Within this broad working area, many different customers’ projects and with various biopharmaceuticals the QC department differs from traditional QC labs. The position requires an engaged, ambitious scientist with interest in particular environmental monitoring, regulations, knowledge of Microbiology and GMP biopharmaceuticals production.

Tasks and Responsibilities

The position requires knowledge within environment monitoring of clean rooms and preferable microbiological analyses.

You will be responsible QC scientist for clean room environment and microbiological analyses in the department, where evaluation of results and generation of project related GMP documentation will be a natural part of your daily work. Gathering data for reports, writing deviations and constantly optimize procedure (SOP’s, TEQ’s ect.) ensure continuous compliance with cGMP with a LEAN mindset. Further, you will be involved in EM re-/qualification of production room.

Your profile

The ideal candidate holds a MSc or PhD degree in Pharmacy, Microbiology or other relevant field and has most likely knowledge in several of the following qualities:

• Knowledge on environmental monitoring and qualification of clean rooms
• Experience in pharmaceutical water testing both chemical and microbiological analyses
• Basic understanding and knowledge of microbiology
• Validation/qualification of microbiological methods and equipment
• Experience with writing protocol and reports for EM, validation and SOPs.
• Regulatory inspections e.g. DMA, FDA and customer audits (internal and external audits).
• General knowledge about regulatory requirement for classified production areas as well for microbiological analyses
• Commercial GMP production and/or with production for late stage clinical trials
• Production of biotechnological products and APIs
• You like to share your knowledge and communicate openly and professionally both internally and with external customers
• You take responsibility for your personal assignment and thrive at reaching them in a timely manner
• 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
• Excellent communication, presentation and interpersonal skills
• Ability to apply organizational skills to systems and efficiency improvement

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 Biologics offers a dynamic working place and an excellent opportunity for working and growing with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a biologics contract development and manufacturing organization interact in order to achieve success. Exciting and challenging assignments will keep coming your way, but you will largely be able to plan your daily work on your own. AGC Biologics offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC employees have a flexible attitude and we help each other to reach deadlines together as one team, in accordance with our slogan – Right. On Time.

We will process the candidates as they arrive. Therefore, please submit your application and CV as soon as possible. When the right candidates are found, the add will close. We are therefore looking forward to receive your application today!

For further information regarding the position, please contact Sr. Manager, Susanne Vestergaard at +45 22942932.

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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.