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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