Scientist – Quality Control – Environmental monitoring and Microbiology

  • Job reference
    4260877112

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 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 as scientist in QC Microbiology department (consisting of 10 highly dedicated technicians, 6 skilled scientists and one manager). QC Microbiology is responsible for environmental monitoring (EM) in clean rooms, 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, QA, 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 environmental monitoring, regulations, knowledge of Microbiology and GMP biopharmaceuticals production.

 

Tasks & Responsibilities

The position requires expertise within clean room environment and preferable also microbiological analyses.   
You will be responsible 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.
A part of the job will be to give input to customer project teams, preparing for method validation (e.g.  bioburden validation for clinical phase I/II through full validation) and commercial licensing.
Through internal and external audits you can expect to build great expertise within these areas by interacting with our many different international customers.

 

Uddannelsesniveau
{Education}

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:

  • Solid knowledge on environmental monitoring and qualification of clean rooms 
  • Experience in pharmaceutical water testing both chemical and microbiological analyses
  • Solid microbiological understanding and knowledge
  • Validation/qualification of microbiological methods and equipment
  • Experience with writing validation protocol, validation report, 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.

 

                                                                                                              

Sprog
{Language}

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. 

How to apply
Interested? Apply with CV, Motivation, references and criminal record via the link on this page, and do it as soon as possible. AGC Biologiscs is partnering with Adecco on this recruitment, so if you have any questions about the position, you can contact our recruitment team: 

Line Heyn +45 5185 7005
Christina Drejet +45 3838 7007 

 

 

 

About AGC Biologics 
AGC Biologics (AGC) is a global Contract Manufacturing Organization (CMO) with biomanufacturing facilities in Europe, Japan 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.  
 
AGC Biologics also offers non-exclusive license to CHEF1™, a proprietary CHO cell line development platform. CHEF1 delivers stable, high-titer, production-quality cell lines in optimized time frames. It is the foundation of AGC Biologics’ innovative approach to cell line and process development.  
 
Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.  
 

 

Andre oplysninger
{TravelAmount}

Om AGC Biologics

Kontaktoplysninger
Adecco Recruitment

5185 7005 / 3838 7007