Senior Formulation Scientist

CY Partners ,
Chippenham, Wiltshire
More Details
Salary: Up to £45,000 per annum

Overview

Senior Formulation Scientist An excellent opportunity has come up for an experienced formulation scientist to join a growing pharmaceutical company at their R&D facility in Wiltshire on a permanent basis. The Senior Formulation Scientist serves as a technical resource for projects which consist of New Chemical Entities and novel formulations for Phase I clinical studies, late phase projects and lifecycle management. Joining a department responsible for product development, including external Contract Management and analytical, formulation and process activities coordination, this is a key technical role in the business. The Senior Formulation Scientist will lead an environment of formulation, technical innovation and continuous improvement ensuring that all quality and productivity targets are achieved through the optimum use of resources. The main aspects of the role include: · Leading project specific respiratory formulation development. · Design appropriate formulation and stability studies including the use of QbD where appropriate. · Design and execute experimental protocols in a timely manner and in compliance with company requirements including the interpretation and reporting of results and findings. · Organisation and scheduling of work and resources to timescale and budget. · Working with global CMC project teams to lead product development activities and innovation. · Conduct necessary safety assessments and qualification plans according to current procedure, authoring, reviewing and managing the execution of IQ/OQ/PQ protocols, · Writing, Reviewing and Approval of SOPs and Risk Assessments. The successful candidate will have significant proven experience in formulations, ideally across different dosage types and working environments. The following experience is also preferable: · Knowledge and experience in powder mixing (DPI), and preferably pMDI, nebulized formulations, particle engineering and solid state characterization. · Experience in inhalation products performance testing. · Significant experience in managing external CDMOs, CROs and suppliers for Tech transfer and scale-up, Tox batch manufacture; Phase I and Phase II stability studies and clinical trials supply. · Experience in technical writing of IND and IMPD documents. · Good understanding of ICH, EMEA and FDA guidelines related to inhaled products development. · Knowledge of inhalation devices and experience in selection and handling of them. This is a great opportunity to utilise your wide range of formulation experience in a respected technical position within a growing R&D team. If this sounds like the opportunity for you, apply with your CV now, and feel free to contact Tom Kirkpatrick at CY Partners for more information. During the current Covid-19 crisis, many sites are understandably limiting visitors, including for interviews. The next steps in this process will be a skype interview, with an on-site visit to follow when restrictions are lifted. This job was originally posted as www.totaljobs.com/job/89918926

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