CMC Biologics is a Contract Manufacturing Organization producing Active Pharmaceutical Ingredients (API) for different biopharmaceutical companies worldwide. The Copenhagen facility is capable of large scale manufacturing of API using cell culture or microbial technology.
Our multiproduct facilities offer you the opportunity to work in a state-of-the-art environment with modern equipment and the newest technologies. You will experience a dynamic working environment with a great variety of tasks, and an environment where cGMP production never becomes routine.
You will be part of our Microbial Manufacturing team consisting of 16 professionals distributed on scientists and technicians.
The team has upstream and downstream processing know-how, and is working together on execution of processes from thaw of vial to final fill. Typical processes are based on E. coli fed-batch cultures (often inclusion bodies) or Pichia fed-batch (methanol) high cell density cultures (secreted products).
The team manufactures API according to the CMC quality system following cGMP at all aspects of the daily work.
We are responsible for implementing and starting-up of new projects collaborating internally and with customer delegates on producing Master Production Records and ensuring equipment and facility capabilities are matching the requirements of the new process.
Tasks and Responsibilities
Depending on your education and level of experience you will be responsible for the following tasks:
• Project responsible scientist (PRS) for assigned projects:
o Upstream/Downstream representative in a project group consisting of PRS’s from different departments that perform cross-functional work to ensure a successful project execution and communication with international clients.
• Implementation of new processes in close collaboration with our Project Transfer team and Development teams.
• Write quality documents, such as Master Production Records and other technical procedures.
• Planning and coordination of manufacturing campaigns.
• Follow-up on ongoing production campaigns including client communication, review and approval of batch records, troubleshooting, handling of deviations and CAPA’s.
• Upstream/downstream manufacturing
• Scientists will run processes working with state of the art technology:
o Upstream: 1500 L bioreactors
o Downstream: centrifugation, homogenization, solubilization, re-folding and filtration.
You hold an MSc in Biotechnology, Chemical Engineering or similar. In addition, we expect experience in some of the following areas:
• Knowledge of the bio-pharmaceutical industry.
• You are dynamic with the ability to operate and manage changes with a positive attitude.
• You have the ability to keep the overview and prioritize even when you are busy.
• You are a goal oriented team player, a good collaborator and have good communication skills.
• For candidates interested in the position, it is important to have practical experience and solid theoretical knowledge of upstream or downstream manufacturing.
CMC is an international organization with sites both in Europe and the US and our company language is English. It is therefore vital to be proficient in written and spoken English.
Join an international and agile organization
At CMC, you will get great opportunities to work with a varied array of tasks and challenges. You will
get experience with our various departments as well as exciting and challenging assignments.
Furthermore, you will to a large extend be able to plan your daily work yourself. CMC offers an informal working environment, where high energy and enthusiasm is part of the daily work life. We respect each other and our individual differences. CMC’s employees have a flexible attitude and we help each other to reach deadlines together as one team.
For further information please contact HR Business Partner Jeppe Højrup on phone +45 2294 2942. Alternatively, please contact Microbial Manufacturing Manager Dennis Jørgensen on phone +45 4137 7913.
We will process the applications as they arrive. Therefore, please submit your application and CV as soon as possible and no later than February 28th, 2017.