(Senior) Fill/Finish Process Development Specialist
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Janssen Vaccines & Prevention, we are searching for a (Senior) Fill/Finish Process Development Specialist.
Janssen Vaccines & Prevention is dedicated to bringing meaningful innovation to global health. They focus on the discovery, development, manufacturing and marketing of vaccines and antibodies to protect people world-wide from infectious diseases.
As Fill Finish Specialist, you are one of the key contributors in the process development activities from technology transfer to the manufacturing site, until manufacturing of process verification/validation batches to be introduced in the global market. You will be part of a dynamic and accomplished team and are responsible for:
- The setup, reporting and timely execution of process development, characterisation and (process) validation activities. These activities can be done in-house or externally;
- Establishing and maintaining a trustful and professional relationship with the different stake holders from other departments within the company as well as with external partners;
- The technical content of the registration dossier, by guaranteeing availability of source documentation and raw data;
- Leading and/or participating in specialised committees, as appropriate to ensure continuous improvement on departmental and project level;
- Managing and challenging the various stages of the project by:
- Preparing and periodically updating project plans;
- Reporting periodically and escalating when needed;
- Judging when and what (external) knowledge should be sourced in during the development stages and manage accordingly.
Who we're looking for
We are looking for a person who works with passion, is full of initiative and capable of analysing problems on a high level. The ideal candidate has an M.Sc. in pharmaceutical sciences with at least 5 years of experience in vaccine and/or large molecule process development and GMP drug product manufacturing. You should be able to communicate your ideas within an international team clearly and proactively in proficient English. Experience with technology transfer and out sourcing is advantageous.
Additional vacancy information
Contract: Temporary contract with CLS Services
Terms: Project for at least 1 year, longer-term anticipated. Full time preferred, 32 hours discussable. Must be able to travel up to 10% and stay abroad for up to 1 week.
Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555