Do you have experience in pharmaceutical inhalation development?
Have you previously worked in a technical leadership role? As well as managing a budget? Then I may have the perfect role for you!
Principal Formulation Scientist
My client, a global pharmaceutical company based in Chippenham, is looking to recruit a Principal Formulation Scientist. The successful applicant will have diverse experience in inhaled formulation, product development (drug substance and drug product), process transfer, material science, particle engineering and quality control and quality assurance. This is a great opportunity for an experienced Formulation Scientist!
Key responsibilities of the Principal Formulation Scientist are:
* Working on projects which consist primarily of New Chemical Entities and novel formulations Phase I clinical studies, late phase projects and lifecycle management.
* Provide overall technical leadership regarding cGMP compliance and improvements, as well as manage budget, CAPEX, efficiency improvements (i.e. lean).
* Leading project specific respiratory formulation development.
* 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.
* Working with global CMC project teams to lead product development activities and innovation.
The ideal candidate for the Principal Formulation Scientist role will have:
* An BSc in Formulation Science or related scientific subject
* Complete understanding and application of principles, concepts, practices, and standards for formulation and testing performed in formulation laboratories.
* Experience with testing of inhalation products.
* Experience in all aspects of external contractors management (CROs/CDMOs).
* Experience in a wide range of technical aspects related to drug substance micronisation, formulation feasibility, scale-up, tech transfer, specifications setting, filling studies, packaging, device selection support.
* Experience in GMP documentation technical writing
If you are an experienced inhalation formulator and this sounds like you, please apply now!
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