Based at our client's, newly established Dublin office, the process chemist will develop robust synthetic processes and deliver non-GMP & GMP material on the multi-kilogram scale in a safe and efficient manner. The process chemist will be involved in implementing strategies to progress compounds from preclinical development through commercialisation with a specific focus on delivering drug substances to support clinical and commercial needs for all company small molecule programs.
The Process Chemist will be involved
- Process chemistry for compounds under development and conduct route optimisation to deliver non-GMP & GMP material on the multi-kilogram scale.
- Work with CMOs to manage process development and manufacturing of intermediates and API.
- Involved in phase appropriate synthetic route design and implementation of control strategies for regulatory starting materials, intermediates and APIs.
- Fate and purge studies and genotoxic impurity evaluation.
- Technical transfers of intermediate/API processes and support external manufacturing activities by acting as PIP (person in plant).
- Work cross-functionally to communicate process chemistry timelines and objectives.
- Contribute to quarterly updates of process chemistry budget and resource allocation.
- Support PAR studies, pre-validation and validation activities for drug substance.
- Author and review the relevant CMC sections for US and ex-US regulatory filings.
- Work with quality assurance to manage the release of GMP drug substance and resolve technical issues or deviations.
- Review and approve master batch records, validation protocols/reports and specifications required for drug substance manufacturing.
Ph.D. or BS/MS with 3-5 years of experience in organic chemistry, chemical engineering, pharmaceutical sciences or closely related discipline with relevant small molecule development experience.
Knowledge of current Good Manufacturing Practices (cGMP).
Ability to manage multiple projects and rapidly adapt to changing program needs.
Strong track record in process chemistry development, CMO management and multi-kilogram scale manufacturing.
Ability to effectively organise and prioritise tasks to achieve deadlines.
Up to 25% travel will be required to support external manufacturing.
For further information on this process Chemist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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