Job Description
Our client, a major multinational pharmaceutical manufacturer based in Dublin, now have a permanent role for a Senior Process Development Chemist to support the launch and commercial manufacturing of new technology for the company.
The successful candidate will work as SME on the site?s products, acting as a key team member in the transfer for a new drug substance throughout the tech transfer lifecycle from planning, process performance and regulatory support, representing the site to stakeholders.
Responsibilities for Senior Process Development Chemist:
Lead technology transfer, process scale-up to commercial scale, process monitoring and process troubleshooting for small molecules for existing processes on site.
Collaboration with R&D to support the development and the technology transfer of new drug candidates to commercial sites.
Driving process robustness performance through process capability analysis and assessment.
Application of Lean tools and techniques to assess process robustness. Identifying and executing process robustness improvement projects.
Providing technical leadership in the understanding of root causes for out of trend or out of specification results or deviations through application of standard tools.
Champion new technology for process understanding/Monitoring.
Maintain/develop links with external networks including Universities & Industry groups.
Provide coaching, technical oversight and support for the activities of other chemist with the department. Support the development of other chemists on-site.
Requirements for Senior Process Development Chemist:
PhD in Synthetic Organic Chemistry.
7+ year?s relevant pharmaceutical industry experience, ideally with commercial manufacturing processes.
Subject matter expertise in crystallization process development, proven experience in with analytical/diagnostic tools including PAT.
Experience of CMC regulatory requirements for pharmaceutical products and the evolving opportunities offered by application of QbD principles.
Experience in defending processes, procedures and investigations during FDA/EMA/HA inspections is desirable.
Demonstrated ability to work across a matrix is desirable.
Subject Matter Expert in relevant API chemistry, process development, process management and troubleshooting, process robustness improvement.
Good understanding of 21CFR/cGMP documentation, electronic systems requirements and EHS requirements.
Please phone Larry on +353 1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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