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Business Manager, MES

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 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 engineers, technicians, scientists and support staff 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. Come join our team and make a meaningful impact on patients’ lives.   

Reporting directly to the Program Director of the MES during the project phase and Director of Material Operations post project phase, the Business Process Owner will serve as an integral member of both the MES project team and the Material Operations team based in the Shanbally biologics drug substance manufacturing facility.

The Business Process Owner will be ultimately responsible for the MES system in Shanbally including the availability, support and maintenance of the system.

The Business Process Owner will be required to foster a close working relationship with multiple departments at a local level but also globally within Manufacturing, IM and Automation as well as other groups such as Quality Operations and Validation to ensure customer requirements are met.

Business Process Owner will be responsible for people management of direct reports including development, coaching, appraisals and performance management.

It is expected the Business Process Owner will develop a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions that result in safe, agile and compliant manufacture of Drug Substance material.

A high level of initiative, energy and motivation are key role requirements, as well as organizational and people management skills.

RESPONSIBILITIES

Managing the MES team to support manufacturing planning, execution, quality assurance, and reporting

Support the full system lifecycle, including the design, development, interfaces, test, validation and implementation of new requirements

Responsible for the MES support function on site to ensure 24/7 technical cover for the business

Determine resource, system and process requirements by collaborating with business owners to anticipate business needs for the Shanbally MES function taking into account the future needs of a rapidly growing business

Serve as primary site MES point of contact with the Global MES team related to vendor management, core functional & system requirements, and system enhancement request management 

People management of direct reports of recipe modellers and business analysts

In conjunction with Technical Owner (IM), Vendors and MES Support Team, resolve any system performance issues, identify hardware repair/replacement and ensure service supplier communications are well maintained

Ensure that adequate communication plans are in place and delivered to ensure that all stakeholders are informed and consulted on key MES activities, progress and decisions.

Ensuring adequate training for the MES team; budget management for technical related expenses

Develop process metrics for MES function that measure effectiveness towards achieving goals, provide visibility to improvement opportunities, and track progress of improvement initiatives

Instil the use of Right First Time (six-sigma) and lean practices leading to operational excellence.

Represent MES group as necessary at critical meetings.

Develop and demonstrate an active approach to safety, environmental and regulatory compliance

Coach, mentor and train colleagues on MES business processes, use of operational excellence tools, and high performance team behaviours

EDUCATION AND EXPERIENCE

Master or Bachelor's degree in Computer Science, Sciences or Engineering, or equivalent years of experience.

At least 8 years of experience in MES/Bio-pharmaceutical industry with minimum 3 years of experience in managing a team

Demonstrated leadership and development of high quality talent desired

Past experience and demonstrated ability to successfully influence team performance in a high performance team is strongly preferred.

Highly developed organizational and leadership skills.

Proven ability to partner senior business stakeholders effectively is required

Experience in MES-ERP integration will be highly preferred

Experience/Knowledge in ERP, LIMS, EDMS, QMS, MES (PAS-X) preferable

Knowledge and understanding of ERP data requirements related to supply chain and/or manufacturing

Experience with Werum PAS|X a preference

An understanding of GxPs, and/or computer validation and Part 11 / Annex 11 requirements.

Strong knowledge of business processes across manufacturing, supply chain & quality

Experience with Computer Systems Validation preferred

Very strong interpersonal and communication skills.

Yellow/Green Belt in Lean Six Sigma

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.

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Cork

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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