Skip Navigation

Global CMO Packaging Project Specialist

Location Cork, Ireland
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Commercial organization supports our global sales and marketing efforts around the world. Our global sales force continues to solidify the company’s commercial presence in the United States and Europe and is rapidly growing in other regions, such as Latin America, the Middle East and Asia-Pacific. Come join our team and make a meaningful impact on patients’ lives.

Global CMO Packaging Project Specialist

In Ireland, BioMarin operates a Biopharma Manufacturing Site in Shanbally, Co. Cork, and a Global Commercial Operations Hub in Dublin.

What makes working here unique? At BioMarin, we feel the intense tie between the work we do and the life-changing results it delivers. Our focus on rare disease gives us the rare opportunity to truly impact lives. As BioMarin employees, we’re here because we want to be here. We enjoy our work — and each other. Our people are smart. Unassuming. Collaborative. Curious. Interesting. In return, there is development, empowerment and total reward. 

Role Summary

BioMarin has a high-performing, team based organisation, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key role requirements, as well as excellent organisational skills.

The Global CMO Packaging Project Specialist will serve as an integral member of the CMO team who have responsibility for clinical and commercial Biologics Sterile Filling and Packaging operations globally, supporting >75% of BioMarin revenue.  This role has two primary responsibilities:

1. Project manage a variety of CMO technical projects, with a focus on Serialisation Implementation initially, from CMO pack site validation activities, to 3PL and Wholesaler Readiness, and L4 Technical Integration activities.   Act as the key link between the Global Packaging Operations group and CMO Operations groups to deliver commercial packaging processes or process updates.

  1. Serialization SME for BioMarin’s Global Serialization Programme – this covers a broad range of competencies including but not limited to GS1 standards; artwork coding requirements; regulatory requirements; distribution & warehousing best practises; L4 EPCIS messaging.

Note, as the Serialisation programme nears full implementation, this role will broaden focus and support BioMarin’s contract packaging operations organisation with project management of key initiatives such as technical transfers and process improvements.

The Commercial Packaging Project Specialist will report to the Global CMO Packaging Project Manager.

Role Responsibilities

  • Project Manage a variety of CMO technical projects
    • Project manage a number of sub streams of the overall Serialisation Programme.
      • CMO Validation Activities
      • Distribution Partner Readiness
      • L4 Technical Integration Readiness
      • BioMarin Business Readiness
    • As Serialisation Implementation nears completion, the focus will switch to technical transfers and CMO process improvements
    • Execute change controls and master data updates as required
    • Liaise effectively with CMO Operations, Quality, Regulatory, Packaging Engineering and other relevant functions to ensure project plans are delivered in full, and on time
    • Provide regular updates at Governance meetings
    • Work with broader CMO team to define and implement business critical improvement opportunities
    • Where areas of risk are identified the project specialist will support the risk assessment process and act appropriately with the teams to mitigate or remove the risk.
  • Help develop a culture of ownership and accountability within the extended project team
  • Build strong relationships with CMO partners and internal cross functional groups; sharing information and best practices

  • Serialisation SME for BioMarin Serialisation implementation across CMO and Distribution sites in readiness for global Serialisation deadlines
    • Maintain a deep knowledge of all ongoing serialization regulatory requirements and implementations at the various sites and distribution partners ensuring successful implementation and mitigating risks as necessary
    • Serialisation Master Data owner – work with other relevant functions to ensure there are efficient processes in place to support the introduction of new SKUs into the future
    • Build Serialisation knowledge and act as SME for all related queries. Build Serialisation capabilities amongst the broader organisation. Develop FAQ and best practice documents to support this.
    • Lead BioMarin/partner (CMO, 3PL) sub-teams focused on serialization implementation, ensuring successful execution by required deadlines.
    • Define annual budget required for global serialization programme
    • Work with Legal to ensure all contracts are executed to enable compliant serialization, including software, country-specific serialization contracts, and MSAs.
    • Lead the cross functional troubleshooting of any Serialisation related issues or alerts throughout the supply chain and ensure systemic fixes are put in place to prevent re-occurrence.

Requirements

  • A relevant third level qualification in science, engineering, business administration, or related disciplines.
  • A minimum of 4 years’ experience working in a highly regulated manufacturing environment (pharmaceutical, medical devices, etc) is required.
  • Prior project management experience or qualifications would be favourable
  • Serialisation and GS1 experience would be preferred
  • General Supply Chain experience from Packaging through to Distribution & Warehousing required.
  • Proficiency with Trackwise and with Oracle or other materials management systems is desired. Excellent general computer application skills are required.
  • Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment is an advantage.
  • Working knowledge of GMP/GDP regulations is desired.
  • Must have excellent written and verbal skills coupled with excellent interpersonal skills. Experience in Technical Writing is a distinct advantage.
  • Must be quality oriented and possess a rigorous attention to detail, coupled with a demonstrated track record of delivering on goals and on initiative to institute change.
  • Must be a team player and be skilled at influencing without authority.
  • Lean, six-sigma or other operational excellence background desirable

This role can be based in either Shanbally or Dublin.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.


We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

About our location

Cork

View

Hiring Insights

View
We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
Return to the top of the page