Join a dynamic and international company where everyone is responsible for delivering right on time as One Team!
Are you looking for new challenges in an international and inspiring environment?
We are replacing one of our microbiology Scientist in Quality Control.
The Quality Control unit at CMC Biologics A/S consist of three teams; QC Bioassay, QC Chemistry and QC Microbiology (with 6 highly dedicated technicians and two scientist). QC Microbiology is responsible for microbiological analysis on API’s for clinical trials and commercials, environmental monitoring in clean rooms, chemical/microbiological analyses on pharmaceutical water, and TOC analysis on production rinse samples.
The department has a close collaboration with; Manufacturing, QA, Up- and Downstream Development, Analytical Development and External laboratories to gain control of all steps in the manufacturing processes. Everything we do, we do in close collaboration with our customers.
Tasks and Responsibilities
The position requires expertise within microbiological analyses and clean room environment. You will be responsible scientist for microbiological analyses and clean room environment 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. One of your task will be to coordinate safety test with external laboratories for all mammalian manufacturing lines.
Through internal and external audits you can expect to build great expertise within these areas by interacting with our many different international customers.
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:
•Experience in pharmaceutical water testing both chemical and microbiological analyses
•Solid microbiological understanding and knowledge
•Solid knowledge on environmental monitoring and qualification of clean rooms
•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 microbiological analyses as well for classified production areas
•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
CMC has international customers and our company language is English. It is therefore vital to be fluent in written and spoken English.
CMC offers a dynamic workplace with good opportunities to work with a wide and varied range of tasks and challenges. You will be inaugurated in and have experience with the way the various departments in a "Contract Manufacturing Organization" (CMO), collaborate to achieve success. Exciting and challenging assignments will come to you in a steady stream, and you will very largely able to plan your day. CMC offers an informal and humorous working environment that is characterized by the fact that we think it is fun to go to work. We respect each other and our differences. CMC employees are flexible and take pride in working together to achieve goals - as one team.
For further information regarding the position, please do not hesitate to contact Manager QC Microbiology Susanne Vestergaard, phone +45 2294 2932.
We will process the applications as they arrive. Therefore, please submit your application and CV as soon as possible and no later than October 15, 2017. We treat the applications as we receive them, and qualified applicants can expect to be interviewed before the deadline.
About CMC Biologics A/S
CMC Biologics (CMC) is a global Contract Manufacturing Organization (CMO) with three biomanufacturing facilities in Europe 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.
CMC 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 CMC Biologics’ innovative approach to cell line and process development.
to learn why CMC Biologics is a World Leader in process development and contract manufacturing.