Senior Fill/Finish Process Development Specialis
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 Specialis.
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.
The team focuses on the development of novel therapeutics and vaccines to treat, cure and prevent some of the most devastating and complex infectious diseases. These range from respiratory infections like respiratory syncytial virus (RSV) to human immunodeficiency virus (HIV) and pathogens of global concern such as polio and Ebola. We are driven to action by the plight of patients and we seek to make a positive impact in their lives.
The Fill Finish Process Development Specialist is 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 set-up, reporting and timely execution of process development, characterisation and validation activities. These activities can be done in-house or externally;
- 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;
- 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.
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. You should be able to communicate your ideas within an international team clearly and proactively. Proficient English both on paper and verbally is a must. Knowledge of Dutch is a plus.
You will work for a global company and you will be part of a truly global and international organisation. You can have MSc/BSc in pharmaceutical sciences or other relevant disciplines (i.e., pharmacy, (bio)chemistry or other life sciences or engineering). At least 5-year experience (10 year for Senior. position) in vaccine and/or large molecule process development and GMP drug product manufacturing is required. Experience with technology transfers and outsourcing is an advantage.
It is a highly dynamic environment which requires you to have a strong work ethic, expect change and be creative. This position may require travelling and staying abroad for up to 1 week.
Additional vacancy information
Contract: Temporary contract with CLS Services
Terms: Project for at least 1 year.
Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555