Johnson & Johnson Careers
DPD Process Engineer
Requisition ID: 1905718437W
Janssen Pharmaceutica joined the Johnson & Johnson group in 1961. Today, Janssen Pharmaceutica is one of the most innovative pharmaceutical companies in the world. Our research and development centre develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions.
Global Drug Product Development (DPD) is within the Pharmaceutical Development & Manufacturing Sciences (PDMS) organization of Janssen (Johnson and Johnson), responsible for the development of Pharmaceutical Dosage Forms. Development centers are located in the US, Asia and Europe. Within DPD, the process engineering group, supports E2E formulation and process development activities. Focus is on the characterization of products and processes in order to further optimize development and transfer activities and establishing the required toolbox and skill sets.
For the location in Beerse we are looking for talent in the DPD Process Engineering group.
The overall mission of the role is to strengthen the formulation and process development capabilities for oral and parenteral solid and liquid dosage forms by establishing more quantitative correlations between process parameters and material attributes on the one hand and process/product performance on the other. The function holder is accountable for developing and maintaining a process understanding toolbox and supports the deployment in the project portfolio.
Key elements of the role are: process design/development and process optimization based on scientific and engineering insights, innovation, customer focus, teamwork, international networking.
Specific responsibilities for you are:
- Identify the mechanisms governing drug product process, product performance and scale up using underlying physical and chemical principles as well as properties of materials. These processes include dry/wet granulation, tableting, spray drying, melt extrusion, film coating, nanonization, liquids mixing, filtration, wet grinding, etc.. Both batch and continuous processing are in scope
- Where relevant, assess suitability of statistical models to support process development
- Evaluate critical to scale process and equipment parameters that can affect performance at a larger scale (e.g, blend times, shear rates, compaction/compression forces)
- Effectively use experimental “scale-down” models of process unit operations to evaluate process parameters and ranges in lab and pilot plant
- Define and evaluate CQA’s, CPP’s and CMA’s and determine as an outcome the control strategy
- In support of formulation and process development of the product portfolio, support design of most optimal experimental approaches, design relevant DOE’s and conduct statistical data analysis
- Support Quality-by-Design and Design-to-Value process development and regulatory filing, explore applicability of modelling approaches in filing strategy
- Give support to Continued Process Verification/Validation, Process Performance Qualification and Robustness Index
- Develop Best Practices / Decision trees / Development Plans for process modelling during drug product development and ensure deployment to the broader DPD community.
- Act as Process Engineering SME in selected project and review teams
- Interact with clinical and commercial supply chain to implement a standardized approach towards process development, scale-up and modelling to support and tech transfer and lifecycle optimization
- Write and review scientific reports and manuscripts
- Ensure overall compliance with regulatory requirements, GMP and PbOEL (Performance based occupational exposure level)
- Follow-up literature (scientific and patent) in order to create new development opportunities for pharmaceutical development
- Ph.D. in Chemical or Mechanical Engineering, Bio-engineering, Biological, Physical or Pharmaceutical Sciences or a Master Degree with equivalent years of expertise in Pharmaceutical industry.
- You have at least 3-5Y of relevant experience.
- You have expertise in engineering, process development, scale-up, and optimization
- You have experience in process mechanistic and statistic modelling for dosage form development and manufacturing.
- Your have knowledge of chemometric modelling.
- You have experience in setting up DOE’s and statistical analysis.
- Experience with scale up and technology transfer for pharmaceutical manufacturing.
- Experience working within GMP environment, implementing and maintaining high quality standards for all aspects of the work conducted including adherence to regulatory, GMP compliance, departmental, and safety guidelines.
- You are able to work well within cross-functional teams and provide leadership through effective communication skills.
- Experience with implementation of innovative technologies and principles in the development of robust and marketable forms.
- You have participated in industry workshops, attended scientific meetings, and monitored relevant scientific literature.
- Familiar with root cause analysis methodologies.
Janssen Pharmaceutica N.V. (7555)