Cell Culture Operations Manager
We seek an experienced and skilled professional to lead our cell culture operations at our Cork site.
The successful candidate will have a strong background in biologics manufacturing, with experience in cell culture and/or purification processes.
Key Responsibilities:
* Deliver production plans for Drug Substance Manufacturing within the AOP & LRP timeframe.
* Own Cell Culture processes end-to-end and operational performance indicators.
* Lead and develop the Cell Culture team and broader Drug Substance team through active development planning, succession planning, and talent mapping.
* Control operational expenses related to Drug Substance manufacturing, including yearly and long-range planning budget management with quarterly forecasting, scrap management, and variance management for standard costing.
* Ensure Safety metrics improvement, risk analysis, and implementation of corrective actions for the Drug Substance area.
* Oversee Quality metrics, deviation management, CAPAs, and change controls for the Cell Culture and broader Drug Substance manufacturing area.
Requirements:
* Bachelor's degree in biotechnology, chemical engineering, biochemistry, or biosystems engineering, or equivalent experience preferred.
* Leadership experience within the GMP Biologics Drug Substance operational environment, demonstrating Decision Making, Influence, Collaboration, Agility, and Leadership at the appropriate level.
* Past experience and ability to influence team performance in a high-performance team is strongly preferred.
* Demonstrated ability in communication and interaction across cross-functional teams.
* Ability to train and coach colleagues in processing, operational excellence, team interactions, and delivering results.