- With more than 8500 people in approximately 40 countries, our company offers an exciting working environment where initiative can flourish and those with a ‘can-do’ attitude can thrive.
- Scientific excellence, innovation, co-creation, lateral thinking, reinventing the way we do things…these are some of the key competencies we are constantly developing, and looking for, at our company.
Job Scope and responsibilities
- The successful candidate for this job will become a key member of the Drug Product NCE development department.
- The primary responsibility of this position is to apply in a systematic manner QbD (risk assessment, PAT, DoE and modelling) to support formulation and process development of NCEs.
- To act as the point of contact for QbD and PAT in DP formulation and process development.
- In support of formulation and process development of the product portfolio, to select and perform relevant PAT studies, design relevant DoEs and conduct statistical data analysis.
- To identify and understand the mechanisms governing drug product process and product performance and scale up using underlying physical and chemical principles as well as properties of materials.
- To evaluate critical to scale parameters and equipment parameters that can affect product performance at larger scale.
- Effectively use PAT and scale up principles of unit operations to confirm or modify understanding of CPPs at pilot and manufacturing scale.
- To define and evaluate CQAs, CPPs and CMAs and determine as an outcome of the risk assessment the control strategy including relevant models, PAT systems and process regulations.
- Using PAT & chemometric modelling, to improve the scientific understanding of pharmaceutical processes (blending, granulation, milling, spray-drying, tableting and coating processes in batch mode or in continuous mode) and formulations.
- To create the framework and strategy for modelling of continuous manufacturing technologies.
- To give support to Continued Process Verification / Validation, Process Performance Qualification.
- To develop new technologies, new tools and new applications to optimize formulations, manufacturing processes enabling integrated CMC development.
- To write and review scientific reports and manuscripts.
- To follow up scientific literature in order to create new development opportunities for pharmaceutical development.
- PhD in Pharmaceutical Sciences or in Engineering / Bio-engineering.
Experience and skills:
- A minimum of 2 years professional experience in the pharmaceutical industry with a focus on drug product formulation and process development is a strong asset.
- Expertise in in-line PAT method development (NIR, Raman, particle characterization analyzers, softsensors, …).
- Experience on the implementation of PAT in the context of CM is a plus.
- Sound knowledge and understanding of off-line analytical reference methods (UPLC, LOD, laser diffraction, …).
- Expertise in chemometric modelling using Matlab, SIMCA, JMP.
- Experience with data alignment softwares such as SiPAT or Syn TQ is a plus.
- Expertise in designing DoE and statistical analysis on JMP or MODDE.
- Experience on developing control strategies is a plus.
- Detailed understanding of NCE DP development including: formulation and process development, scale-up, technology transfer.
- Knowledge on development risk assessment.
- Knowledge on GMP and QbD regulatory requirements .
- Communication, influencing and negotiation skills to represent the department internally and externally.
- Demonstrated ability to coordinate and track activities.
- Ability to work independently as well as within multidisciplinary teams in an international environment.
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