Senior Process Validation Lead—External Manufacturing (DS/DP)

Fastnet; Cork; Hybrid; EUR 70,000 - 90,000; Full time

Job summary

A leading biopharmaceutical company in Cork is seeking an experienced professional to lead validation activities for drug products in collaboration with external manufacturers. The ideal candidate has over 10 years of industry experience, including specific expertise in oligonucleotide or synthetic drug substance processes. This role offers a hybrid working model, with remote work possible for the right candidate.

Qualifications

• 10+ years industry experience required.
• 5+ years in Process Validation (DS or DP).
• Strong experience with oligonucleotide or synthetic DS.

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.

Skills

Process Validation

Communication skills

Documentation skills

Ability to travel

Job description

A leading biopharmaceutical company in Cork is seeking an experienced professional to lead validation activities for drug products in collaboration with external manufacturers. The ideal candidate has over 10 years of industry experience, including specific expertise in oligonucleotide or synthetic drug substance processes. This role offers a hybrid working model, with remote work possible for the right candidate.