Johnson & Johnson Careers
Principle scientist Drug Product Development (Parenterals and Liquids)
Requisition ID: 1905738063W
Global Drug Product Development is a department of Small Molecule Pharmaceutical Development (SMPD) within Discovery, Product Development and Supply (DPDS), responsible for the development of Pharmaceutical Dosage Forms. Development centers are located in the US, Asia and Europe. For the location in Europe (Belgium, Beerse) there is a vacancy for a Principle Scientist with expertise in complex and innovative drug delivery solutions for different administration routes.
The position is specifically within the Parenterals and Liquids group. 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 systems
The overall mission of the role is to strengthen the formulation and process development
capabilities for the complex projects. Key elements of the role are: innovation, customer focus, teamwork, international networking and building up the scientific knowledge/expertise.
Specific responsibilities of the role are:
- Execute formulation and process development activities in the area of parenteral and liquid dosage development with specific focus on complex and innovative approaches
- Identify opportunities for innovation, built further on the current formulation platforms so various approaches can be evaluated in the projects.
- Give support to scale up and tech transfer of the developed processes in close collaboration with the Janssen Supply Chain
- Built up a strong relationship with collaborating departments and stakeholders such as Pharmaceutical Sciences, Analytical Development, SM API development, Portfolio Management, Clinical Supply Chain, Janssen Supply Chain, etc.
- Use his/her global network in order to set up collaborations with external partners and follow-up on Pharmaceutical Development activities in line with the department strategy
- Follow-up literature (scientific and patent) in order to create new development opportunities for Pharmaceutical Development
- Write and review of protocols and characterization reports
- Ensure overall compliance with regulatory requirements, GMP and PbOEL (Performance based occupational exposure level)
- Reach out to Preclinical, Toxicology, Clinical Pharmacology, Therapeutic Area, Marketing, etc. in order to find opportunities for improved drug product development
- Ph.D. in Pharmaceutical Sciences, Industrial Pharmacy, Biochemical Engineering, Chemical Engineering, Biological or Physical Sciences or Equivalent by experience with a Bachelor or Master Degree in the Relevant Areas.
- At least five years of experience or equivalent with a demonstrated competency and experience in drug product development within the pharmaceutical industry is required, mainly in the spray drying field.
- Broad, end-to-end expertise in formulation and process development for liquid and parenteral dosage forms, i.e. scientific and technical expertise in delivery technologies and physical pharmacy
- Experience with scale up and technology transfer to pilot scale and commercial manufacturing of pharmaceutical processes, including setting up DOE’s, applying scale up modelling methodologies, understanding process parameters, etc.
- Experience with implementation of state-of-the-art technologies and principles in the development of robust and marketable dosage forms, determining critical quality attributes, critical process parameters and critical material attributes.
- Experience working within GMP requirements, implementing and maintaining high quality standards for all aspects of the work conducted including adherence to regulatory GMP, departmental, and safety guidelines.
- Track record in writing skills, scientific papers, development reports, protocols, etc. Ability to build up a broad network within Janssen as well as externally, academics, CRO’s, etc.
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.
Janssen Pharmaceutica N.V. (7555)