Kelly Services are recruiting for an experienced R&D Formulation Scientist for a Waterford based pharmaceutical company. The formulation scientist will act as a SME for the development innovative drug product formulations that meet patient needs.
- 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 EirGen Pharma'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.
Health & Safety:
- Ensure requirements of EirGen's Safety Statement are implemented.
- Continuously promote a positive safety culture by leading by example & drive a high EHS, 5S & housekeeping standard in areas under the roles control.
- Implement safety requirements as per site documentation including SOP's, Safety Statement and COP's.
Minimum Qualifications & Experience
- 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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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.