Principle Scientist, Drug Product Development – Parenteral drug delivery expert Job

Job description

Principle Scientist, Drug Product Development – Parenteral drug delivery expert-1500068481WDescriptionParenterals and Liquids group is a department of Pharmaceutical Development and Manufacturing Sciences –Drug Product Development (PDMS-DPD). The department is responsible for end-to-end drug product development for large and small molecules including:
- Formulation development activities for oral and parenteral administration for early, mid and late stage molecules
- Process development activities for oral and parenteral formulations
- Formulation and process transfer activities to pilot and manufacturing plants
- Life cycle management and support of operations at pilot and manufacturing plants.
- Development of liquid formulation technologies to enhance patient compliance such as pediatric formulations and injectable sustained delivery systemsDescription of the functionThe Principal Scientist will play a key role and lead the development of liquid formulations and processes for assigned small molecules. The position will require hands-on laboratory work, project responsibility and oversight of development activities at external parties. The Principal Scientist will provide technical support to regulatory submissions of new and existing drugs and act as a spokesperson on development related aspects during FDA pre-approval inspections.
The Principal Scientist will develop and/or advise teams in the development of manufacturing processes of new oral liquid and sterile liquid pharmaceutical products for PDMS focused on process rationale, process characterization, up-scaling properties, process verification on pilot scale up to transfer to commercial site. He/She will work together with the JSC-GTS Parenterals, Liquids & Creams Platform Leaders in executing and maintaining joint PDMS/JSC platform processes and will support process tech transfer and process validation at clinical or operational sites.
The role requires the development of strong relationships with partner groups in Drug Product Development, Analytical Development, Drug safety sciences and Janssen Supply Chain.
Qualified applicants will have extensive experience within a pharmaceutical organization developing enabling liquid formulations for poorly soluble compounds, designing and validating aseptic/sterile processes, and must have shown excellence in development of oral and injectable formulations. A background in formulation development of pediatric drug products is beneficial. The candidate will have a proven track record in writing criticality analysis, regulatory filing documents and scientific responses to inquiries from Health Authorities and also will have experience in guiding junior scientists in development activities.
The successful candidate should possess excellent interpersonal, project management and problem solving skills and the ability for high performance in a matrix environment.
Qualifications
- A Minimum of a master degree in pharmaceutical sciences, Industrial Pharmacy or a related field with at least 15 years experience is required.
- Demonstrated competency and experience in drug product development within the pharmaceutical industry is required.
- Drug Product Development experience that spans early through late phase is required.
- Background in aseptic process development of injectable solutions and suspensions is required, and knowledge of oral formulation development is desired.
- Successful work experience in a matrix organization is preferred.
- Good oral, written (extensive experience in writing of scientific reports and filing documentation) and presentation skills are essential.
- Good knowledge of Dutch and English is required.
What’s in it for you…?“Caring for the world, one person at a time…”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 e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-BeerseOrganization: Janssen Pharmaceutica N.V. (7555)Job Function: R&D