Assoc. Director, Drug Substance Commercialisation

Merck & Co., Inc.

Ballydine, Tipperary, Ireland
Hybrid
Process chemistry and engineering principles
Cgmp and glp regulatory compliance
Process development and scale-up expertise
This role leads the provision of technical support for the introduction and production of clinical and commercial active pharmaceutical ingredients at the Ballydine site

Job Summary

  • This role leads the provision of technical support for the introduction and production of clinical and commercial active pharmaceutical ingredients at the Ballydine site.
  • The successful candidate will oversee evaluation of raw materials, optimization of chemical API routes, and manage transfers of processes to other company sites or external partners.
  • The position requires developing and coaching team members while ensuring all laboratory and operational activities are conducted safely in compliance with current GMP and GLP requirements.

Matching Summary

This role leads the provision of technical support for the introduction and production of clinical and commercial active pharmaceutical ingredients at the Ballydine site.

Skills & Requirements

Must-have

  • Process chemistry and engineering principles
  • cGMP and GLP regulatory compliance
  • Process development and scale-up expertise
  • Deviation management and investigation
  • Equipment and cleaning validation

Nice-to-have

  • Strategic thinking and leadership
  • Cross-functional collaboration skills
  • Lean manufacturing experience
  • Innovative problem solving abilities
  • Budget oversight and financial management

Key Requirements

  • Degree (BSc/BEng) in Chemistry or Chemical Engineering
  • Strong background in process chemistry and engineering
  • Experience with electronic batch records and control systems like DeltaV

Work Rights

Not specified

Tailored Resume

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