Senior Manager

1 day ago

Cork, Cork, Ireland beBeeCellCultureManager Full time €150,000 - €170,000

Job Overview

The Head of Cell Culture Operations will lead the cell culture function and co-lead the Drug Substance flow team/business unit in a matrix team as part of the site operating model.

Main Responsibilities
  • Ensure production plan delivery for Drug Substance Manufacturing within specified timeframes.
  • Own cell culture processes end to end, including operational related performance indicators.
  • Lead and develop the Cell Culture team and broader Drug Substance team through active development planning, succession planning & talent mapping.
  • Manage all operational expenses related to Drug Substance manufacturing, including yearly and long-range budget management with quarterly forecasting, scrap management, and variance analysis.
  • Oversee Safety metrics, improvement plans, and risk analysis for the Drug Substance area.
  • Responsible for Quality metrics, Deviation management, CAPAs, and change controls for the Cell Culture & broader Drug Substance manufacturing area.
  • Require strong technical understanding of biologics manufacturing (cell culture and/or purification).
  • Be an active leader in operational safety and champion Behavioural Based Safety.
  • Focus on compliance, cost awareness, and lean manufacturing.
  • Responsible for daily operations management systems and service provision to support future operations.
  • Champion continuous improvement with proven delivery of initiatives that reduce costs, increase safety, and compliance.

Requirements

  • 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.

Education

A Bachelor's degree in biotechnology, chemical or biochemical engineering, biochemistry, or biosystems engineering, or a related field is preferred.

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