about 1 month ago
A career changing opportunity with a new bio-pharmaceutical start-up based in Dublin. This organisation has recently set up a new European operation in Ireland having recently launched in Europe with an impressive portfolio of products in various stages of development predominantly focused on the treatment of rare diseases . The newly appointed Head of European Quality is looking to a hire an Associate Director of QC/Analytical Developement. If you are looking for a new challenge and to get in at ground level within a start-up environment, then this will be the perfect role for you.
- Manage outsourced analytical activities for commercial and late-stage drug development products
- Manage the API manufacturing technical relationships with CMO's
- Review analytical data for compliance and revise SOPs as needed (e.g. Analytical Methods, Equipment Procedures, Material Specifications, Stability Studies, etc.)
- Manage and trend stability study data and associated computerized software
- Assemble and document data for Quality Assurance review
- Author or review qualification/validation protocols and transfer protocols
- Author scientific reports and analytical chemistry portions of CMC section of regulatory filings, Annual Reports, and updates to IND’s and IMPD’s
- Conduct analytical investigations and troubleshoot technical challenges at contract testing laboratories
- Bachelor and/or Masters degree in a scientific related discipline
- 7+ years of GMP/GDP experience
- Experience in a virtual organisation or working with CMO’s is desirable
The Next Step for you…
Should this position be of interest to you please forward your CV to Emma Wickham from Next Generation Recruitment or alternatively call on the main line on +353 1 6629120.
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