Scientist Drug Product Process Development
Company: International Biopharmaceutical
Location: Leiden Area
Starting date: January (preferred)
Currently we are actively recruiting a Scientist Drug Product Process Development for a multinational pharmaceutical company that has been for over 25 years a leader in the field of biomedicine. Our client is dedicated to bringing meaningful innovation to global health. Our team focuses on the development of novel therapeutics and vaccines to treat, cure and prevent infectious diseases. The Corona pandemic has a huge impact on public life and the world economy. Besides Corona, 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.
The Process Development group within the Drug Product Development department is responsible for early- and late-stage process development activities in drug product manufacturing. The developed manufacturing processes are transferred to external GMP production facilities to produce clinical batches as well as for scaled-up process validation/verification and commercial manufacturing. This is done in close collaboration with both internal and external partners. Would you like to be part of our team to contribute to this groundbreaking development and bring life threatening diseases to a halt?
In this position, you will be working in an outstanding team to develop fill/finish processes and technology transfer of innovative vaccines. Your main responsibilities are to:
- establish and maintain a trustful and professional relationship with the stakeholders from departments within the company as well as with external partners;
- understand and provide input to define the technical content of the registration dossier, by guaranteeing availability of source documentation and data;
- setup, report and timely execute process development, characterization and validation activities, which can be done in-house or externally.
- lead and participate in specialized committees, to ensure continuous improvement on departmental and project level.
- Preferably a Ph.D. degree or MSc degree in biopharmaceutical sciences, biotechnology or related fields.
- A proven experience in late-stage pharmaceutical development and GMP drug product manufacturing, including technology transfers.
- Experience with two or more of the following is a pre: life cycle process validation; regulatory submission writing; technology transfer; process improvements.
- You work with passion and demonstrate strong leadership and initiative
- You can analyze problems on a high level
- You have a critical demeanor and an amazing scientific and quality attitude
- Our highly dynamic environment requires you to have a strong work ethic, be resilient to change and be creative.
- Good communication and interpersonal skills with stakeholders
- Project management skills
- Excellent written and oral communication skills in English
What we offer:
As an employee we consider you as our most valuable asset. We take your career seriously. As part of a global team in an innovative environment your development is key and our day-to-day responsibility. Through various projects and programs, we ensure your personal growth. Our benefits ensure we care for you and your family now and in the future! We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
If you are interested in this position, please apply or email firstname.lastname@example.org