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.
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 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.
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement.
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.
