Head of Cell Culture Operations, Senior Manager
Location Cork, Ireland Workstyle Onsite Only ApplyWho We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
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.
Head of Cell Culture Operations, Senior Manager (Onsite Role)
Shanbally, Ringaskiddy, Co. Cork
Closing Date: 30th September 2025
Reporting to the Manufacturing Head, the Head of Cell Culture Operations will work in a team environment that is aligned with the manufacturing value stream, and will be committed to continuous improvement, process understanding, personal development, and demonstration of production techniques that will result in agile and compliant manufacture of BioMarin Products.
The Head of Cell Culture Operations will have direct leadership over the cell culture function and co-leadership of the Drug Substance flow team/business unit in a matrix team as part of the site operating model.
Main areas of responsibility:
Main areas of responsibility:
- Delivery of production plan for Drug Substance Manufacturing through the AOP & LRP timeframe
- Ownership of the Cell Culture processes end to end and all operational related performance indicators
- Lead and develop the Cell Culture team and broader Drug Substance team through active development planning, succession planning & talent mapping
- Financial control of all operational expenses related to Drug Substance manufacturing including yearly & long-range planning budget management with quarterly forecasting, scrap management and variance management for standard costing.
- Responsibility for all Safety metrics, improvement plans and risk analysis for the Drug Substance area.
- Responsibility for all Quality metrics, Deviation management, CAPAs and change controls for the Cell Culture & broader Drug Substance manufacturing area.
- Strong technical understanding of biologics manufacturing (cell culture and/or purification)
- Active leader in operational safety & championing behavioural based safety
- Strong focus on compliance, cost awareness, lean manufacturing
- Responsible for the tiered daily management systems & daily management of operations to service the next stage of operations
- Continuous improvement champion with proven delivery of numerous initiatives that have reduced costs, increased safety & compliance
- Experience in tech transfer of new products to commercial facility (at scale or scale up)
SCOPE
The Head of Cell Culture Operations will operate in the Drug Substance Operational areas within the broader Manufacturing Operations function within the Shanbally site to support End to End Operations.
The Head of Cell Culture Operations will operate in the Drug Substance Operational areas within the broader Manufacturing Operations function within the Shanbally site to support End to End Operations.
This role will lead a team of direct reports and a form part of a team of cross functional leaders to ensure seamless coordination and execution across the organisation.
EDUCATION
Bachelor’s degree in biotechnology, chemical or biochemical engineering, biochemistry or biosystems engineering, or related field or equivalent experience is preferred.
Bachelor’s degree in biotechnology, chemical or biochemical engineering, biochemistry or biosystems engineering, or related field or equivalent experience is preferred.
EXPERIENCE
- Leadership experience within the GMP Biologics Drug Substance operational environment with strong demonstration of Decision Making, Influence & Collaboration, Agility and Leadership at the appropriate Level
- Past experience and demonstrated ability to successfully influence team performance in a high-performance team is strongly preferred.
- Strong demonstrated ability in the area of communication and strong ability to interact across cross-functional teams
- Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results.
- Experience with regulatory inspections and direct interaction with regulatory inspectors.
- Demonstrated management of resources, schedule and equipment is strongly preferred.
- Track record of embedding a strong Quality culture. QMS experience preferred
- Highly developed organisational and leadership skills.
- Process development and/or technology transfer experience preferred.
CONTACTS
Work closely with Manufacturing, Validation, EHS, Automation, Manufacturing Science and Technology Group, Quality Operations and Facility Services personnel to ensure timely management of Manufacturing improvements & CAPAs.
Work closely with Manufacturing, Validation, EHS, Automation, Manufacturing Science and Technology Group, Quality Operations and Facility Services personnel to ensure timely management of Manufacturing improvements & CAPAs.
SUPERVISOR RESPONSIBILITY
The Manager will typically have ~5-10 direct reports and broader responsibility for a frontline (shift based) execution team of approx. 40 personnel.
The Manager will typically have ~5-10 direct reports and broader responsibility for a frontline (shift based) execution team of approx. 40 personnel.
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, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.