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Formulation Scientist

Quality & Laboratory
Waterford
Siobhán Lane
Permanent
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Job Reference: JO-2012-65491_1607006893

Summary:


Responsibilities:


* Assist the Analytical & Formulation Development Manager (& Head of R&I) in achieving company goals with specific focus on responsibilities related to the R&D Formulation Science function.


* Work closely & collaboratively with other members of the Formulation Science, and function along with the Analytical & Process Development functions along with other members of the R&D and Commercial value streams to achieve goals.


* Work with the Analytical & Formulation Development Manager, Innovation team and Scientific Affairs (both PMO and Regulatory/Clinical) to foster innovative thinking within the R&D function & to champion the development of innovative medicines in a timely fashion according to stakeholder expectations.


* Execute and/or oversee the design & development of formulations that are built on sound scientific, regulatory, QbD, process validation, and lean product development principles.


* Assist in the improvement of existing drug product formulations within the organization by retrospective application of sound scientific, regulatory, QbD, process validation, and lean product development principles.


* Champion the use of QbD and scientific thinking in the development innovative drug product formulations while maintaining a comprehensive knowledge of formulations development disciplines through research and scientific literature.


* Act as SME for the interpretation of in-vitro data to predict in-vivo performance & how this relates to further formulation development.


* Identifying, assessing, recommending and implementing internal and external opportunities to broaden the site's technical/scientific capability.


* Work to create an excellence/SME culture within the formulation science function that is focused on innovation, lean & robust formulation development, & continuous improvement.


* Identification, organization and implementation of effective training programs within the Formulation Science group including this role.


* Where required, represent the development group in all relevant meetings, for example pipeline steering committee meetings and R&D value stream.


* To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.


* Ensure contemporaneous collection of relevant data for R&D Tax Credit claim purposes.



Requirements:


* BSc in a chemical science related discipline such as Material Science, Industrial Chemistry, Formulation Science or related discipline, post graduate qualification highly desirable.


* At least 5 years' proven experience in a formulation development environment which significant experience in studies that include drug & material characterisation and selection.


* SME level knowledge of QbD and pharmaceutical development processes.


* Demonstrated capabilities in project management & technical leadership of complex product/process developments, at least two years is highly desirable.


* Demonstrated ability to be self-motivated and focus others with respect to implementing identified improvement initiatives.


* Demonstrated ability to work as part of diverse teams in an all-encompassing manner.


* Have demonstrated effective research skills, including the critical review of the scientific literature.



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Talent Consultant:
Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
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