Senior Development Chemist

  • Tipperary
  • Permanent
  • JO-1812-64090_1545306137

Summary

Senior Development Chemist

Role
* Support and Lead the development of Phase III chemistry processes and the launch of the resulting new products and their continuous supply.
* Working with leading scientists from our labs and research and commercialisation facilities in the USA
a. In the development of robust synthetic routes for late stage clinical or commercial active ingredients through working in our lab
b. In addition, working on new chemistries and new technologies during the initial process development of new products for commercial scale in our labs.
c. Providing dynamic support to manufacturing operations on site and off site through process maintenance, troubleshooting and process development.
d. Providing technical and chemistry support as leading Chemist in technology transfers to other sites.


POSITION RESPONSIBILITIES
1. Responsible for process research and development on new Drug Substances and ensuring developed processes are in compliance with the filings. Provide assistance in the preparation of new drug applications and annual filing updates. Act lead Chemist for new product introduction or technology transfers.
2. Lead the identification of improvement opportunities and the development of the process along with the documention of same through a Change Control process with laboratory work where appropriate and generation of validation documentation and assist in the management of the process validation.
3. Applies fundamental scientific principles and business knowledge to develop and execute on small improvement/ maintenance projects e.g. Process Changes for basic source change.
4. Provide technical support and expertise to production during processing. This involves monitoring of key campaign parameters (yield/ quality) and taking appropriate action where necessary. This involves making real time technical assessments and determining the pathforward when deviations occur, documenting the investigation.
5. Defining efficient cleaning processes and documenting in the cleaning technical assessment for new products.
6. Support project assignments as required, for example shift support, Kaizen assignments. Effectively utilises LSS tools to resolve process issues.
7. Ensuring all laboratory work is conducted in a safe and clean environment. This involves ensuring all GMPs, Housekeeping rules and safety guidelines are adhered to including ensuring lab and waste risk assessments are available prior to lab work. May be responsible for maintenance of laboratory equipment and maintenance/ upkeep of laboratory batch sheets for assigned processes.
8. Independently prepares and completes assigned documentation and reports required to support plant operations, tech transfer and regulatory filings. Authors brief milestone reports to facilitate knowledge management.
9. Gives internal presentations and talks. Seeks guidance from support groups, department experts, where appropriate. Able to interpret, understand and apply data provided by support groups (i.e. ADC, EPSE, Quality etc). Provides technical input (data and interpretation) for plant preparations; integrates observations.
10. Collaborate with commercialization partners (CERD/CCTO, Pharm, Process Research, Operations) to support piloting and launch of new products.



Qualifications

  • Have a PhD in organic chemistry with significant relevant experience in process research and development in a pharmaceutical environment.
  • Have excellent communication skills both verbal and written with a proven track record of working in cross-functional and multi-disciplinary teams.

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