JOB DESCRIPTION & SPECIFIC OBJECTIVES
Support 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
- In the development of robust synthetic routes for late stage clinical or commercial active ingredients through working in our lab
- In addition, working on new chemistries and new technologies during the initial process development of new products for commercial scale in our labs.
- Also provide dynamic support to manufacturing operations on site and off site through process maintenance, troubleshooting and process development.
- Ensure that process development and preparation of new drug applications is in compliance with GMP and filed regulatory requirements.
- Support the documenting of planned changes to the process through Change Control and laboratory work where appropriate.
- Generate validation documentation (protocols/ plans/ completion reports) and assist in the management of the process validation
- Generate validation documentation (protocols/ plans/ completion reports) and assist in the management of the process validation.
- Provide technical support to production during processing through monitoring of key campaign parameters (yield/ quality) and taking appropriate action where necessary.
- Develop and support the defining of efficient cleaning processes and documenting in the cleaning technical assessment for new products.
- Support the development objectives for the assigned process through the identification of improvement opportunities
- Ensuring all laboratory work is conducted in a safe and clean environment.
- Supports the preparation and completion of documentation and reports required to support plant operations, tech transfer and regulatory filings. Authors brief milestone reports to facilitate knowledge management.
- Participates in Learning/Knowledge Sharing
- Attends local scientific and development talks. Will present/talk on topics relevant to their knowledge, projects they have worked on
Have a PhD in Organic Chemistry or a minimum of BSc at 2.1 with significant relevant experience in process development. I
Have excellent communication skills both verbal and written with a proven track record of working in cross-functional and multi-disciplinary teams.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
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The Life Science Specialists