(Senior) Director CMC

The organisation

For a brand new spin-off of the VIB (Flemish Institute of Biotechnology), we are looking for a (Senior) Director CMC. The company will be developing a camelid antibody that shows great promise for the treatment of COVID-19. At the start, the brand new company will consist of 3 people (CEO, CMO and Director CMC) and will be acting as a virtual organisation while being supported by a big pharmaceutical company. The goal is to successfully finish the CMC development by the end of the year, as to start the clinical trials by next year. Therefore, they are looking for an experienced CMC specialist that can help the company to fast-track this process.

The position

As Director CMC and one of three employees, you will have a big impact on the success of the company and you will take full end-responsibility over the CMC development. Based on your previous experience with antibody development, you will determine the strategy as to make the process as smooth as possible and avoid the usual pitfalls.

You will be the face and spokesperson in the collaboration with the bigger pharmaceutical partner, which will take care of the operational part of the CMC development. You will make sure their approach follows the strategy that you have set forward, as well as challenge them on their methodology/results and make sure the work is done according to the timelines.

In this position, you will be the counterweight in the collaboration and you will have a high visibility role towards the big pharmaceutical partner as well as to the larger scientific community.

Candidate profile

To be successful in this position, you bring at least:

• PhD or equivalent in a relevant Life Science discipline
• 7 years or more industry experience
• Multiple years of overall CMC project management (not only regulatory)
• Successful from a to z in at least 1 monoclonal antibody project
• Can do attitude, you see opportunities where other people see roadblocks

For this position, following aspects will be considered a plus:

• Previous experience with camelid antibodies
• Background in hands-on formulation development
• Able to start the position at the beginning of August

The offer

We offer you the opportunity to join a very dynamic set-up and have a strong strategic impact on the successful development of a drug that can save lives on the short term. You will have a high-visibility role within an area that is a hot topic in the scientific world. Of course this comes with a matching compensation package and both an FTE or consultant contract can be discussed. Furthermore, you will have the opportunity to work fully home-office.

Interested?

You are invited to apply for this position by following the link below.