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Scientist Formulation Process Development (2x) Leiden Netherlands,
Posted on : 22 November 2016
A formulation scientist is a dynamic member of a diverse group of experts that can function in both an independant capacity (during daily activities) and a team player. The formulation scientist povides input in the design of drug-excipients compatibility studies based on the development strategy and executes desired DoE in consultation with other experts in this fast-paced environment.As an expert, the candidate must be able to engage scientists and engineers at all levels in the organisation and drive succes through leveraging knowledge capabilities.In addition, the scientist can mentor and assist more junior members of the team to allow rapid deployment of key understandings. Also provides input in the design of pre-formulation study based excipient selection and execute corresponding experiments.The scientist will be expected to provide timelines and communicate timelines. This includes communicating risks to success. Responsibilities 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. Technical Scope 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. Culture and interactions with others 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. Qualifications 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. Preferred Education Requirement: Pharmacist, PharmD. Required Experience and Skills: 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. Preferred Experience and Skills: Quality-by-DesignAffinity with laboratory automation systems.
2333 CL Leiden, The Netherlands, South Holland, Netherlands
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