BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-tying 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 coordinate the worldwide movement of our drugs to patients.
Come join our team and make a meaningful impact on patients' lives.
Drug Product Operations Team Lead
Drug Product Operations Team Lead is a role based in the new Drug Product facility at Shanbally.
Onsite Role - Shanbally, Ringaskiddy, Cork
Closing Date - 15th December ****
All drug product technicians and shift leads from respective shifts will report to the Drug Product Operations Team Lead.
The 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; coordinate resources, establish priorities, be the point of escalation for the team and ensure schedule and deadlines are met.
The Team Lead will lead the team through successful start-up activities, process validation and regulatory inspections.
It is expected the 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 organisational 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 (Daily Ops meeting, S&OE, Functional Lead Team meeting, etc.)
Responsible for reporting out on key performance indicators (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 re-validation and validation efforts required for commercial manufacturing
Instil 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 behaviours
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 optimisation that helps create a strong value proposition for future investment (including input into current capital projects)
Required to work closely with the Operations Manager & Engineering to support the delivery of the Drug Product strategic master plan
Strong focus on 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 performance in a high-performance team is strongly preferred
Track record of embedding a strong quality culture.
Trackwise experience preferred
Demonstrate strong communication skills and the ability to interact across cross-functional teams
Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering result
Experience with regulatory inspections and direct interaction with regulatory inspectors
Highly developed organisational and leadership skills
Process development and/or technology transfer experience preferred
Contacts
Work closely with QA Operations, GMSAT & TDS CoE, Engineering, Material Operations & technicians & BPS's to support escalation resolution and implement effective CAPAs.
Supervisor Responsibility
The Operations Team Lead of a given functional area will typically have ~8-15 direct reports; technicians and shift leads.
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.
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.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
To be considered for this role you will be redirected to and must complete the application process on our careers page.
To start the process click the Continue to Application or Login/Register to apply button below.
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