Our client a pharmaceutical company in Mayo is looking to hiring a Senior Pharmaceutical Scientist.
Responsible for technical support activities at a site-based role to support small molecule products, existing eye care (unit dose and Multidose) and new product technologies e.g. eye care implant products. This position is responsible for providing strong scientific leadership for all aspects of technology transfer, process scale-up, process monitoring and process troubleshooting for Active Pharmaceutical Product (API) and Drug Product commercial manufacturing activities.
The position will also involve leading cross functional teams to support process development and technology transfer of products for clinical supply and successful regulatory approval of new product submissions.
- Participate in and/or lead cross functional teams with other functions including R&D, Engineering, Quality, Supply Chain, Operations and Validation
- Support process development and technology transfer of products for clinical supply and successful regulatory approval of new product submissions.
- Provide strong scientific leadership for on-going marketed commercial products providing technical support and expertise to troubleshoot and lead investigational enquiries where necessary
- Review and/or authoring of technical documents including protocols, reports, batch manufacturing documents and CMC sections of regulatory dossiers.
- Management of high quality products within project timelines and on budget
- Clear and effective communication of ideas and results, written and verbal, to technical and non-technical audiences.
- Active contribution of functional area continuous improvement initiatives
- Represent Pharm Tech team on cross functional project teams as needed
- A minimum of 5 years’ experience in pharmaceutical or medical device industry
- Prior knowledge of aseptic processing is considered an advantage
- Strong knowledge of regulatory guidelines, quality systems, drug product manufacturing and validation.
- Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
- Experience executing technology transfers and performing process scale-up.
- Project management skills including the ability to manage multiple projects and evaluate project resource requirements
- Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.
- Previous experience with LEAN or Six Sigma is desirable, but not an absolute requirement.
- The qualified candidate will possess strong technical and writing skills, organizational, communication skills, and function well as an individual contributor
- A minimum of a bachelor’s degree in chemistry, pharmacy, engineering or related scientific field is required, advanced degree is preferred.
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