Scientist Formulation Process Development (2x) - Netherlands
The scientist will be expected to provide timelines and communicate timelines. This includes communicating risks to success.
- Actively contribute to the formulation and process development of generic complex injectables (such as microparticles).
- Assist guiding and coaching a team of formulation engineers.
- Design and perform studies to increase process and product understanding and to be able optimize the same.
- Apply approaches of QbD and in silico simulation to solve challenging technical problems related to formulation development.
- As part of QbD, apply Design-of-Experiment principles to detect and understand critical process parameters and material attributes related to the product under development.
- Collaborate with analytical team members to ensure optimal functioning of the team during the development cycle.
- Remain up-to-date on what is published in the public domain (patents, scientific articles etc).
- Actively participate in building a center of excellence for de development of complex injectables.
- Proven experience in development of pharmaceutical dosage forms, preferable in industry, more preferred in the area of generic and injectable products.
- Experience in applying and understanding principles of the following formulation techniques: freeze-drying, emulsion and suspension technology.
- Experience in applying and understanding principles of the following characterization techniques: SEM, DSC, XRD, Zetasizer, Laser diffraction, imaging techniques.
- Preferable experience with Design-of-Experiments software packages and using statistical tool (Design Expert, R, Artificial Neural Network, Bayesian Network, Monte Carlo simulation).
- Exemplify mastery of the scientific/technical concepts and techniques, apply these concepts and techniques in pursuit of resolving scientific/technical issues.
- Identify opportunities for investment in new equipments to broaden capabilities in the area on complex injectables.
- Build high performing practices in project teams.
- Provide coaching/mentoring of junior staff.
- Operate effectively in a multi-tasking, cross-functional environment.
- Practice good decision-making principles.
- Have a pro-active and solution based mindset.
- Have a sense of urgency for completing tasks and solving technical challenges.
- Exhibit proficiency in good scientific writing practices.
- Author study protocols, technical reports, and sections in support of product registration efforts.
Education Minimum Requirement:
- PhD degree in Pharmaceutical sciences/Pharmaceutics/Chemical Engineering/Process Technology/Biomedical Sciences or engineering or equivalent.
- MSc degree in Pharmaceutical sciences/Pharmaceutics/Chemical Engineering/Process Technology/Biomedical Sciences or engineering or equivalent.
- Pharmacist, PharmD.
- At least MSc + 10 years, or PhD + 3 years of related experience in formulation development, or other related area.
- Qualified candidates must have proven strong technical skills and a demonstrated record of accomplishment of successfully contributing to the development of pharmaceutical raw materials/actives and/or drug products for human health.
- Experience should include authoring technical documents and high proficiency in formulation laboratory techniques.
- Demonstrated ability to work independently, solve scientific problems, and guide other professionals in a highly collaborative environment is required.
- The candidate will have a personal drive for results and a demonstrated history of achievement in pharmaceutical research & development.
- Affinity with laboratory automation systems.