Packaging Operations Team Lead

Ireland·Corklead

OtherOperations Team Lead

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Quick Summary

Overview

Who We Are BioMarin is a leading, global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. Founded in 1997, the San Rafael,

Technical Tools

OtherOperations Team Lead

Who We Are

BioMarin is a leading, global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. Founded in 1997, the San Rafael, California-based company has a proven track record of innovation, with multiple commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin seeks to unleash the full potential of genetic science by pursuing category-defining medicines that have a profound impact on patients..

About Technical Operations

Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and in Shanbally, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution.

Packaging Operations Team Lead is a role based in either Packaging Suite 1 (Vimizim, Naglazyme & Kuvan) or Packaging Suite 2 (Voxzogo & Palynziq).

All packaging technicians and shift leads from respective shifts will report to the Packaging Operations Team Lead. Packaging Operations Team Lead will be responsible for people management of these direct reports including development, coaching, appraisals, and performance management.

Reporting to the Packaging Operations Manager, the primary role of the Packaging Operations Team Lead is to manage the daily packaging operations; coordinating resources, establishing priorities, being point of escalation for the team and ensuring schedule and deadlines are met.

Packaging Operations team lead will lead the team through successful product launch activities, process validation and regulatory inspections.

It is expected the Packaging Operations Team Lead 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 packaging of Finished goods. A high level of initiative, energy and motivation are key role requirements, as well as organizational and people management skills.

GMP personnel throughout BioMarin are tasked with developing drugs for clinical trials and scaling their production for the commercial market. These individuals are responsible for establishing and maintaining BioMarin’s innovative manufacturing processes and facilities, ensuring quality assurance and quality control to meet regulatory standards, procuring essential goods and services to support manufacturing, and managing the global distribution of our drugs to patients.

Key Responsibilities

· People management of direct reports of packaging technicians and shift

· Lead and support the packaging team to ensure delivery of the production schedule.

· Assist in troubleshooting and facilitate appropriate.

· Support and partner closely with the Packaging BPS, Warehouse, Quality (QA & QC),

· Engineering and other colleagues.

· Represent the Packaging group as necessary at critical meetings (e.g Daily Ops meeting,

· S&OE , Functional Lead Team meeting etc.)

· Responsible for reporting out on key performance indicators (e.g Schedule adherence,

· Changeover performance, Unplanned downtime etc.)

· Develop and demonstrate an active approach to safety, industrial hygiene,

· environmental and regulatory compliance

· Responsible for ensuring training records and training plans are in place and up to date

· Ensure training, master batch records, SOPs and other documents are current and

· compliant under cGMP.

· Lead and support daily operation of processing systems and partner with plant

· engineering colleagues to ensure equipment is reliably maintained and within

· appropriate calibration.

· Partner with validation subject matter experts, prepare/approve validation protocols,

· validation plans, protocol executions, and summary reports in support of ongoing

· revalidation and validation efforts required for commercial manufacturing.

· Instill the use of Right First Time (six-sigma) and lean manufacturing practices leading to

· operational excellence.

· Coach, mentor and train shift leads and packaging technicians on packaging processes,

· use of operational excellence tools, and high-performance team behaviors.

· Assist in preparation of performance evaluations and coaching of staff.

· Assist in the recruitment and hiring process for the Packaging operations team.

· Participate and support plant optimization that helps create a strong value proposition

· Required to worked closely with the Packaging project lead to support the delivery of the

· Packaging strategic master plan.

· Strong focus of visibility boards for packaging metrics and status with particular focus

· on schedule adherence & changeover performance

· Perform desk-based tasks as required. For example, MES exception closure, deviation investigation or other administrative tasks.

· Other duties as assigned.

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.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.