Global Manufacturing, Packaging & Labelling Team Lead
In this role, you will 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:
* Degree: In Packaging/Device/Quality Engineering or related field.
* Experience: In the pharmaceutical, biotech, or related field with knowledge of cGMP, regulatory standards, and packaging processes.
* Skills: Proven skills in project and stakeholder management, technical packaging, and documentation.
* Teamwork: Strong teamwork, communication, and organisational skills.
* Communication: Demonstrates excellent verbal, written, and interpersonal communication skills.
Estimated Salary:
We estimate an annual salary range of £60,000 - £80,000, depending on experience.