Leiden, South Holland
over 1 year ago
12 months min
Senior Fill/Finish process development specialist
Generally Requires 6-8 Years Work Experience
Position: (Senior) Fill/Finish Process Development Specialist (Leiden)
My client is one of the biggest and most respected health care companies in the world. They are dedicated to bringing meaningful innovation to global health. Our 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 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 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 stakeholders 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 specialized committees, as appropriate to ensure continuous improvement on departmental and project level.
Required level of expertise:
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. Proficient English both on paper and verbally is a must. Knowledge of Dutch is a plus.
We are a global company and you will be part of a truly global and international organization. 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.