Senior Process Engineer Drug Product Development - Belgium
Senior Engineer Product Development
- Identify the mechanisms governing drug product process and product performance and scale up using underlying physical and chemical principles as well as properties of materials.
- Evaluate critical to scale parameters 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. Effectively use “scale up” of unit operations to confirm or modify understanding of critical process parameters at pilot and manufacturing scale. Define and evaluate CQA’s, CPP’s and CMA’s and determine as an outcome the control strategy.
- Process and scale-up modelling of pharmaceutical processes to prepare oral, parenteral, solid and liquid dosage forms. These processes include dry/wet granulation, tableting, spray drying, melt extrusion, film coating, nanonization, liquids mixing, filtration, wet grinding, etc.
- In support of formulation and process development of the product portfolio, design relevant DOE’s and conduct statistical data analysis.
- Support Quality-by-Design and Design-to-Value process development and regulatory filing
- Create the framework and strategy for process modelling of both batch- and continuous manufacturing technologies
- Give support to Continued Process Verification/Validation, Process Performance Qualification and Robustness Index.
- Work out Regulatory filing strategy for the different Health Authorities in view of process modelling approach
- Reach out to Technical Operations and the Supply Chain to implement a standardized approach towards process development, scale-up and modelling to support and tech transfer
- Write and review scientific reports and manuscripts
- Ensure overall compliance with regulatory requirements, GMP and PbOEL (Performance based occupational exposure level)
- Develop Best Practices / Decision trees / Development Plans for process modelling during drug product development
- 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.
- We are looking for multiple Process Engineers with different levels of relevant experience, ranging from 0-15 years.
- Expertise in engineering process development, scale-up, and optimization
- Expertise in process mechanistic and statistic modelling for oral and parenteral dosage form development and manufacturing
- Expertise in chemometric modelling
- Expertise with designing 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.
- Ability to work well within cross-functional teams and provide leadership through effective communication skills.
- Experience with implementation of state-of-the-art technologies and principles in the development of robust and marketable oral and parenteral dosage forms.
- The candidate has participated in industry workshops, attended scientific meetings, and monitored relevant scientific literature.
- Familiar with root cause analysis methodologies