Join a Cork based leading biopharmaceutical company's Global Manufacturing, Packaging & Labelling team. In this role, you'll oversee new drug product launches, tech transfers, CMO packaging operations, and GMP documentation for Oral Solid Dose and combination devices.
- Key Responsibilities:
- Packaging Projects & Operations: Lead packaging projects, including new product launches, tech transfers, quality workstreams, and cost-saving initiatives at internal and CMO packaging sites.
- CMO Management: Oversee CMO packaging operations, ensuring compliance with EU requirements.
- Documentation & Compliance: Manage GMP documentation, specifications, and change controls in packaging processes.
- Device & Kit Assembly: Develop and test packaging solutions for combination devices, considering patient needs and regulatory standards.
- Serialization & Regulatory Compliance: Apply serialization standards (EU FMD, DSCSA) and support regulatory documentation review.
- Project Management: Support packaging projects through all lifecycle stages, collaborating with global and cross-functional teams.
- Cost Efficiency & Continuous Improvement: Lead cost-saving initiatives and process improvements in packaging engineering.
- Requirements:
- Education: Technical Degree or Master's in a relevant field.
- Experience: 5-8 years in the Life Science/Biotech industry, including a minimum of 3 years specifically in Project Management.
- Knowledge of cGMP, regulatory standards, and packaging processes.
- Proven skills in project and stakeholder management, technical packaging, and documentation.
- Demonstrates excellent verbal, written, and interpersonal communication skills.
- Locally based: full time onsite requirements.
