Our client is focused on the discovery and development of novel and differentiated therapeutic products, to address high unmet needs amongst various targeted patient populations. Their strategy will be to leverage an asset-rich in-licensing environment, with a focus on areas of high unmet need, utilizing a team with a strong track record of execution in immunology, inflammation, fibrosis and oncology.
Based at our clients newly established Dublin office, the Sr. Manager/Associate Director of Process Chemistry will successfully lead a group of scientists to develop robust synthetic processes and deliver non-GMP & GMP material on multi-kilogram scale in a safe and efficient manner. This individual will be responsible for implementing strategies to progress compounds from preclinical development through commercialization with specific focus on delivering drug substance to support clinical and commercial needs for all company small molecule programs.
- Lead process chemistry for compounds under development and conduct route optimization to deliver non-GMP & GMP material on multi-kilogram scale.
- Proactively work with CMOs to manage process development and manufacturing of intermediates and API.
- Represent Process Chemistry on CMC Sub-teams
- Responsible for phase appropriate synthetic route design and implementation of control strategies for regulatory starting materials, intermediates and APIs.
- Lead fate and purge studies and genotoxic impurity evaluation.
- Lead 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.
- 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 organize and prioritize tasks to achieve deadlines.
- Minimum of 25% travel will be required to support external manufacturing.
- Ph.D. or BS/MS with 7-10 years of experience in organic chemistry, chemical engineering, pharmaceutical sciences or closely related discipline with relevant small molecule development experience.
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