Packaging and Labeling Manager – Ultragenyx Pharmaceutical – Novato, CA, USA
The Packaging and Labeling Manager will manage global drug supply programs/activities, including; secondary packaging vendor selection, technical batch record review, packaging component design, label translation coordination, packaging and labeling, and evaluate distribution practices.
This position manages contract secondary packaging vendors to ensure timelines are met and serves as the labeling representative on relevant project teams to provide strategic input into the label and packaging development.
- Oversee packaging and labeling timelines, set prioritization and schedule jobs with vendors and internal Quality resources.
- Coordinate with Technical Operations, Regulatory, Clinical, and QA to ensure timely release and shipment
- Provide internal departments with packaging options that best meet the needs of the clinical trial or commercial market
- Manage shipments, including importation/exportation compliance, of intermediates or components to the appropriate Drug Product CMO and subsequent transfer of the Drug Product to the packaging and labeling vendor
- Monitor intermediate cold chain shipments and resolve any temperature excursions or product inquiries, arranging for resupply, if necessary
- Manage packaging and label components at vendors, ensuring use of appropriate materials and availability for package and label operations
- Contribute to the design and approval of labels for primary and secondary packaging in order to meet country-specific labeling requirements, including translation of required label text into the appropriate languages
- Identify secondary packaging suppliers based on product requirements
- Interface with QA/QC on product release requirements and timelines
- Coordinate label text review, translations and approvals
- Perform technical packaging batch record review
- Oversee packaging at secondary packaging sites as Person in Plant
- Update and develop Packaging and Labeling SOP’s
- Route changes and documentation through change control system
- Perform Oracle transactions for Purchasing and Manufacturing
- Bachelors in Life Sciences, Business, or Engineering
- 5+ years in the pharmaceutical packaging environment
- Understanding of cGMP’s and pharmaceutical industry procedures and regulations.
- Problem-solving and decision-making skills
- Flexibility and the ability to manage change
- Strong interpersonal skills and the ability to work well as part of a team
- Exceptional verbal and written communication skills, and negotiation skills
- Solid organizational, leadership and time management skills.
- Experience with the following software: Microsoft Word/Excel/PowerPoint, Project/Visio
- Experience with Oracle and Trackwise or similar systems