Drug Product Team Lead

Who We Are
BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.
Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.
Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.
About Technical Operations
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.
Drug Product Operations Team Lead
Onsite Role - Shanbally, Ringaskiddy, Cork
Closing Date - 9th November 2026
Drug Product Operations Team Lead is a role based in new Drug Product facility at Shanbally.
All drug product technicians and shift leads from respective shifts will report to the Drug Product Operations Team Lead. Drug Product Operations Team Lead will be responsible for people management of these direct reports including development, coaching, appraisals, and performance management.
Reporting to the Drug Product Operations Senior Manager, the primary role of the Drug Product Operations Team Lead is to manage the daily operations; coordinating resources, establishing priorities, being point of escalation for the team and ensuring schedule and deadlines are met.
Drug Product Operations team lead will lead the team through successful startup activities, process validation and regulatory inspections.
It is expected the Drug Product 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 filling of Drug Product. A high level of initiative, energy and motivation are key role requirements, as well as organizational and people management skills.
Main areas of responsibility:
People management of direct reports of technicians and shift leads
Lead and support the team to ensure delivery of the production schedule
Assist in troubleshooting and facilitate appropriate escalation
Support and partner closely with the BPS, Warehouse, Quality (QA & QC), Engineering and other colleagues
Represent the Drug Product 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, line throughput, 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 for all team members
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 technicians on 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 operations team
Participate and support plant optimization that helps create a strong value proposition for future investment. (Including input into current capital projects)
Required to worked closely with the Operations Manager & Engineering to support the delivery of the Drug Product strategic master plan
Strong focus of visibility boards for production metrics and status with particular focus on schedule adherence & line throughput
Education:
Degree in science/engineering, operations management or industrial engineering or equivalent experience in a GMP environment is preferred.
Experience:
Demonstrated experience working with GMP Mfg processes
Past experience and demonstrated ability to successfully influence team performanc