GEO Process Team Lead - Small Molecules

Location:  Dublin, Ireland Category: Manufacturing

Description

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 Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These individuals build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

Global External Operations (GEO) Process Team Lead - Cork or Dublin

The GEO Process Team Lead is responsible for the end-to-end operations management for all products within their Process Team.  As a member of the GEO Operations Leadership Team (OLT) the Process Team Lead has responsibility for management of the Make Assess Release (MAR) performance of the GEO site.  The GEO Process Team Lead is also tasked with supporting the execution of the GEO site strategy. 

 

Key Responsibilities

  • Management of the Process Team matrix team to secure uninterrupted supply of clinical & commercial products.
  • Manage end-to-end performance through an effective metrics process, and by establishing improvement plans for all products and sites associated with the Process Team where needed
  • Working with the Operations Manager(s) and Process Team members to negotiate/resolve any issues with the CMO to ensure our supply plan will be met.
  • Own business relationship with the CMO(s) including, but not limited to, Joint Steering Committee (JSC) meetings, continuous improvement plan, strategic relationships.
  • Own and manage the end-to-end budget for all products and CMOs associated with your Process Team. 
  • As a member of the GEO OLT ensure site MAR targets are met and escalations are managed appropriately, ensure operations readiness for new products & tech transfers and end to end performance management.
  • Support the GEO site strategy to the support and/or execution of site strategic projects.
  • Develop a strong team and problem-solving culture within your Process Team to ensure smooth operations management for all products and sites associated with your Process Team. 
  • Manage the career development of all direct reports and support matrix team members with their continual development.
  • Travel to CMO and Internal sites as appropriate

 

EXPERIENCE & Skills:

Minimum requirement of 5 years leadership experience in Operations, Supply Chain or Quality.

BS/BA degree; life sciences, business, or supply chain management

 

Required skills needed to accomplish the responsibilities/essential functions include:

          Will have an excellent understanding of the processes/unit operations assigned to the team.

          Demonstrated ability in leading/managing cross functional, multi-disciplinary teams.

          Ability to guide and support cross functional teams in the resolution of short-term issues and sustained performance for long-term goals.

          Proven track records in effective decision making.

          A high level of initiative, influencing, coaching as well as excellent organizational skills.

         Experienced in working and managing in a regulated GXP environment.

          Strong stakeholder and relationship management experience.

          Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment is desired.

          Excellent organizational, written and verbal communication, commercial acumen.

          Experience in supply planning or inventory management.