Our client, a leading Biopharmaceutical based in Cork, is looking for an experienced professional to lead DP and/or DS validation activities at CMOs across Europe. You’ll play a key role in upcoming PPQs next year and beyond, supporting an exciting pipeline of products heading to commercialization.
Responsibilities
* Lead PPQ strategy, execution & oversight at CMOs
* Support validation for oligonucleotide or synthetic DS manufacturing processes
* Author key sections of regulatory filings
* Serve as technical validation lead during manufacturing runs & partner meetings
* Ensure compliance with global cGMP/validation standards
Requirements
* 10+ years industry experience, including 5+ years in Process Validation (DS or DP)
* Strong experience with oligos or synthetic DS
* Proven track record working with external manufacturing partners
* Excellent communication and documentation skills
* Ability to travel within Europe as required
Hybrid working from Cork preferred — fully remote may be an option for the right candidate.
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