Drug Product Team Lead

<p>Who We Are <br /><br />BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.<br /><br />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.<br /><br />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. <br /><br />About Technical Operations <br /><br />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.</p><p style="text-align: center;"><span style="background-repeat: no-repeat;outline: none;"><strong style="background-repeat: no-repeat;outline: none;font-weight: 600;">Drug Product Operations Team Lead</strong></span></p><p style="text-align: center;"><span style="background-repeat: no-repeat;outline: none;"><strong style="background-repeat: no-repeat;outline: none;font-weight: 600;">Onsite Role - Shanbally, Ringaskiddy, Cork</strong></span></p><p style="text-align: center;"><span style="background-repeat: no-repeat;outline: none;"><strong style="background-repeat: no-repeat;outline: none;font-weight: 600;">Closing Date - 9th November 2026</strong></span></p><p><span style="background-repeat: no-repeat;outline: none;">Drug Product Operations Team Lead is a role based in new Drug Product facility at Shanbally.</span></p><p><span style="background-repeat: no-repeat;outline: none;">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.</span></p><p><span style="background-repeat: no-repeat;outline: none;">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.</span></p><p><span style="background-repeat: no-repeat;outline: none;">Drug Product Operations team lead will lead the team through successful startup activities, process validation and regulatory inspections.</span></p><p><span style="background-repeat: no-repeat;outline: none;">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.</span></p><p><strong style="background-repeat: no-repeat;outline: none;font-weight: 600;"><span style="background-repeat: no-repeat;outline: none;font-weight: 600;">Main areas of responsibility:</span></strong></p><ul><li><span style="background-repeat: no-repeat;outline: none;font-family: Symbol;"> </span><span style="background-repeat: no-repeat;outline: none;">People management of direct reports of technicians and shift leads</span></li><li><span style="background-repeat: no-repeat;outline: none;font-family: Symbol;"> </span><span style="background-repeat: no-repeat;outline: none;">Lead and support the team to ensure delivery of the production schedule</span></li><li><span style="background-repeat: no-repeat;outline: none;font-family: Symbol;"> </span><span style="background-repeat: no-repeat;outline: none;">Assist in troubleshooting and facilitate appropriate escalation</span></li><li><span style="background-repeat: no-repeat;outline: none;">Support and partner closely with the BPS, Warehouse, Quality (QA &amp; QC), Engineering and other colleagues</span></li><li><span style="background-repeat: no-repeat;outline: none;">Represent the Drug Product group as necessary at critical meetings (e.g Daily Ops meeting, S&amp;OE , Functional Lead Team meeting etc.)</span></li><li><span style="background-repeat: no-repeat;outline: none;">Responsible for reporting out on key performance indicators (e.g Schedule adherence, line throughput, Unplanned downtime etc.)</span></li><li><span style="background-repeat: no-repeat;outline: none;">Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance</span></li><li><span style="background-repeat: no-repeat;outline: none;">Responsible for ensuring training records and training plans are in place and up to date for all team members</span></li><li><span style="background-repeat: no-repeat;outline: none;">Ensure training, master batch records, SOPs and other documents are current and compliant under cGMP</span></li><li><span style="background-repeat: no-repeat;outline: none;">Lead and support daily operation of processing systems and partner with plant engineering colleagues to ensure equipment is reliably maintained and within appropriate calibration</span></li><li><span style="background-repeat: no-repeat;outline: none;">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</span></li><li><span style="background-repeat: no-repeat;outline: none;">Instill the use of Right First Time (six-sigma) and lean manufacturing practices leading to operational excellence</span></li><li><span style="background-repeat: no-repeat;outline: none;">Coach, mentor and train shift leads and technicians on processes, use of operational excellence tools, and high-performance team behaviors</span></li><li><span style="background-repeat: no-repeat;outline: none;">Assist in preparation of performance evaluations and coaching of staff</span></li><li><span style="background-repeat: no-repeat;outline: none;">Assist in the recruitment and hiring process for the operations team</span></li><li><span style="background-repeat: no-repeat;outline: none;">Participate and support plant optimization that helps create a strong value proposition </span><span style="background-color: rgb(255,255,255);color: rgb(51,51,51);font-family: 'Open Sans' , Helvetica;">for future investment. (Including input into current capital projects)</span></li><li><span style="background-color: rgb(255,255,255);color: rgb(51,51,51);font-family: 'Open Sans' , Helvetica;">R</span><span style="background-color: rgb(255,255,255);color: rgb(51,51,51);font-family: 'Open Sans' , Helvetica;">equired to worked closely with the Operations Manager &amp; Engineering to support the delivery of the Drug Product strategic master plan</span></li><li><span style="background-color: rgb(255,255,255);color: rgb(51,51,51);font-family: 'Open Sans' , Helvetica;">Strong focus of visibility boards for production metrics and status with particular focus on schedule adherence &amp; line throughput</span></li></ul><p><strong style="background-repeat: no-repeat;outline: none;font-weight: 600;"><span style="background-repeat: no-repeat;outline: none;font-weight: 600;"><span style="background-repeat: no-repeat;outline: none;font-weight: 600;">Education:</span></span></strong></p><ul><li><span style="background-repeat: no-repeat;outline: none;">Degree in science/engineering, operations management or industrial engineering or equivalent experience in a GMP environment is preferred.</span></li></ul><p style="background-repeat: no-repeat;outline: none;font-family: 'Open Sans' , Helvetica;font-size: 14.0px;font-weight: 400;line-height: 20.0px;margin: 10.0px 0.0px;color: rgb(51,51,51);font-style: normal;letter-spacing: normal;text-indent: 0.0px;text-transform: none;word-spacing: 0.0px;"><strong style="background-repeat: no-repeat;outline: none;font-weight: 600;"><span style="background-repeat: no-repeat;outline: none;font-weight: 600;"><span style="background-repeat: no-repeat;outline: none;font-weight: 600;">Experience:</span></span></strong></p><ul><li style="background-repeat: no-repeat;outline: none;font-family: 'Open Sans' , Helvetica;font-size: 14.0px;font-weight: 400;line-height: 20.0px;color: rgb(51,51,51);font-style: normal;letter-spacing: normal;text-indent: 0.0px;text-transform: none;word-spacing: 0.0px;">Demonstrated experience working with GMP Mfg processes</li><li style="background-repeat: no-repeat;outline: none;font-family: 'Open Sans' , Helvetica;font-size: 14.0px;font-weight: 400;line-height: 20.0px;color: rgb(51,51,51);font-style: normal;letter-spacing: normal;text-indent: 0.0px;text-transform: none;word-spacing: 0.0px;">Past experience and demonstrated ability to successfully influence team performance in a high-performance team is strongly preferred</li><li style="background-repeat: no-repeat;outline: none;font-family: 'Open Sans' , Helvetica;font-size: 14.0px;font-weight: 400;line-height: 20.0px;color: rgb(51,51,51);font-style: normal;letter-spacing: normal;text-indent: 0.0px;text-transform: none;word-spacing: 0.0px;">Track record of embedding a strong Quality culture. Trackwise experience preferred</li><li style="background-repeat: no-repeat;outline: none;font-family: 'Open Sans' , Helvetica;font-size: 14.0px;font-weight: 400;line-height: 20.0px;color: rgb(51,51,51);font-style: normal;letter-spacing: normal;text-indent: 0.0px;text-transform: none;word-spacing: 0.0px;">Demonstrate strong communication skills and the ability to interact across cross-functional teams</li><li style="background-repeat: no-repeat;outline: none;font-family: 'Open Sans' , Helvetica;font-size: 14.0px;font-weight: 400;line-height: 20.0px;color: rgb(51,51,51);font-style: normal;letter-spacing: normal;text-indent: 0.0px;text-transform: none;word-spacing: 0.0px;">Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering result</li><li style="background-repeat: no-repeat;outline: none;font-family: 'Open Sans' , Helvetica;font-size: 14.0px;font-weight: 400;line-height: 20.0px;color: rgb(51,51,51);font-style: normal;letter-spacing: normal;text-indent: 0.0px;text-transform: none;word-spacing: 0.0px;">Experience with regulatory inspections and direct interaction with regulatory inspectors</li><li style="background-repeat: no-repeat;outline: none;font-family: 'Open Sans' , Helvetica;font-size: 14.0px;font-weight: 400;line-height: 20.0px;color: rgb(51,51,51);font-style: normal;letter-spacing: normal;text-indent: 0.0px;text-transform: none;word-spacing: 0.0px;">Highly developed organizational and leadership skills</li><li style="background-repeat: no-repeat;outline: none;font-family: 'Open Sans' , Helvetica;font-size: 14.0px;font-weight: 400;line-height: 20.0px;color: rgb(51,51,51);font-style: normal;letter-spacing: normal;text-indent: 0.0px;text-transform: none;word-spacing: 0.0px;">Process development and/or technology transfer experience preferred</li></ul><p><span style="background-repeat: no-repeat;outline: none;font-weight: 600;"><span style="background-repeat: no-repeat;outline: none;"><span style="background-repeat: no-repeat;outline: none;font-weight: 600;">Contacts:</span></span></span></p><p><span style="background-repeat: no-repeat;outline: none;">Work closely with QA Operations, GMSAT &amp; TDS CoE, Engineering , Material Operations &amp; technicians &amp; BPS’s to support escalation resolution and implement effective CAPA’s.</span></p><p><strong><span style="background-repeat: no-repeat;outline: none;">Supervisor Responsibility:</span></strong></p><ul><li><span style="background-repeat: no-repeat;outline: none;">The Operations Team Lead of a given functional area will typically have ~8-15 direct reports; technicians and shift leads.</span></li><li>The Operations Team Lead will be responsible for a group of ~8-15 staff including a full rotating 3 shift operations shift pattern. The role may require the successful candidate to work shift operations that align with the business needs.</li></ul><p>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. <br /><br />Equal Opportunity Employer/Veterans/Disabled <br /><br />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.</p><p>Ireland Safety Responsibility</p><p>Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training. </p>