For an exciting project at our client Janssen Vaccines & Prevention in Leiden we are looking for a senior Process development Specialist / Engineer specializing in Fill-finish.
Janssen Vaccines & Prevention is dedicated to bringing meaningful innovation to global health. They focus 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 and obviously most recently COVID-19.
The Senior Fill Finish 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 of novel vaccines to be introduced in the global market. The focus of this role is not on equipment validation; please focus only on process validation, someone who understands the procedural steps needed to ensure product quality.
The setup, reporting and timely execution of process development, characterization and validation activities. These activities can be done in-house or externally;
Managing and challenging the various stages of the project;
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 stakeholders from other departments within the company as well as with external partners;
Technical content of the registration dossier, by guaranteeing availability of source documentation and raw data;
Leading and/or participating in specialized committees, as appropriate to ensure continuous improvement on departmental and project level;
You have MSc / BSc in pharmaceutical sciences or other relevant disciplines (i.e., pharmacy, (bio)chemistry or other life sciences or engineering);
You have at least 10 years of experience in vaccine and/or large molecule process development and GMP drug product manufacturing - Experience with technology transfers and outsourcing is an advantage;
Specific expertise with Fill-finish in a pharmaceutical environment;
We are looking for a person who works with passion, is full of initiative and capable of analyzing problems on a high level;
You should be able to communicate your ideas within an international team clearly and proactively;
English both on paper and verbally is a must. Knowledge of Dutch is a plus;
Must be able & willing to travel up to 10% and stay abroad for up to 1 week;
Specific soft skills required: self-sufficient and proactive;
Valid work permit for the Netherlands is a must;
Project for 1 year, longer term anticipated;
Open to ZZP / independent contractors;
full-time preferred, 32 hours discussable;
Start: asap, discussable.