My client, a pharmaceutical company with over 50 years of API manufacturing experience are seeking to recruit an R&D PhD Chemist, on a permanent basis.
This position is based at the R&D Centre in Swords, Co Dublin. The R&D Centre has co-located technical and operational expertise, including analytical expertise that supports the development and manufacture of clinical and commercial products (small molecule APIs).
The R&D Chemist will have subject matter expertise in spray drying and materials science.
They will also be responsible for providing support for all aspects of new and existing chemical processes development, technology transfer, process scale-up, process safety, process monitoring, and process troubleshooting for small molecules.
The role will involve cross functional collaboration with other functions including Operations, Quality, SHE and external stakeholders working towards existing and new product introduction and ensuring all processes are understood, robust, efficient and in control.
Key responsibilities of the role:
Contributes to the development of spray drying capabilities at the Ireland site.
Identify opportunities within current portfolio to develop amorphous solid dispersion processes.
Develop spray drying processes with the aid of appropriate statistical tools to design processes, and analytical tool to characterise output material.
Optimise API powder properties, considering scale-up and manufacturing aspects as well as Drug Product requirements.
Provide coaching and guidance for R&D team members on material science and spray drying activities, as required.
Experience with the use of extensive analytical tools (e.g. DSC/TGA/XRD/FTIR/DVS/SSA/FT4/SEM/PSD/HPLC) to characterise crystalline and amorphous materials.
Support technology transfer activities for introduction of new clinical and commercial products to the site, including process development in the laboratory, customer engagement, troubleshooting, documentation, and campaign readiness.
Support assessments for new products as required.
Provide technical support to the manufacture of APIs and intermediates manufactured on site, with a focus on optimisation and investigation support.
Lead optimisation projects on throughput and yield in collaboration with Operations engineers.
Support continuous process verification through collection and trending of data for commercial products, identifying Out of Trends (OOT) and Statistical Alert Events (SAE) and leading investigations where required with support from other functions.
Actively participate in manufacturing campaign performance support teams.
Lead and support quality and safety investigations.
Required Key Skills and Experience:
Subject matter expert in spray drying and material science of APIs with strong technical background in chemistry.
PhD in organic chemistry or related discipline.
2+ years of experience in the pharmaceutical industry.
Strong interpersonal and communicational skills and demonstrated ability to work across a matrix.
Excellent problem solving skills and commitment to continuous improvement.
Expertise in project management, troubleshooting and continuous process verification.
Demonstrated capability in the use of standard tools for root cause analysis and standard statistical tools.
Demonstrated capability in the use of various analytical/diagnostic tools including PAT.
Ensure that GMP, Quality, Health & Safety are considered in all aspects of the role.