Assoc Director Downstream Manufacturing

This leading global biologics organisation provides and offers comprehensive integrated and customisable services to the Biopharmaceutical and related industry sectors from contract development services right through to contract manufacturing services to some of the largest biopharma and pharma organisations globally. Recently, this business has announced expansions into geographies such as the U.S and most recently Ireland, where a significant investment has been undertaken to build a new cell culture green-field manufacturing site which once built, will be the largest single use biologics manufacturing plant globally. This site has been designed to run continuous bioprocessing, a next-generation manufacturing technology which will be implemented for the first time at this site and once complete will employ in the region of 400 staff. With this expansion, an exciting opportunity has arisen for a Downstream/Purification professional/leader to join the organisation at the start-up phase in leading this business through construction and into manufacturing.

The Role:

  • Supervise daily downstream manufacturing activities and ensure production timelines are met
  • Collaborate with Process Development and Project Management groups on technical transfer and process validation
  • Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections
  • Provides working knowledge and technical leadership in purification operations
  • Schedules and/or delivers training to manufacturing personnel to ensure staff can perform manufacturing operations safely and compliantly
  • Motivate, retain and develop existing group members and recruit new staffs to build a strong downstream manufacturing team
  • Contributes to continual improvement of all manufacturing documentation (SOP’s MBR’s, OJT’s) to ensure they are current, accurate, and clear
  • Communicate operational status regularly to senior management, as required, at the appropriate level of detail
  • Assist the MFG1 head to coordinate the work between the downstream groups and other functional groups to meet the production objectives and timelines

The Person:

  • BSc/MS in a scientific discipline or equivalent is preferred
  • Minimum 6-8 years working in a cGMP biological manufacturing environment with previous experience managing subordinates and/or leading project teams
  • Experience in the large-scale chromatography, centrifuge and depth filtration harvest, ultrafiltration/diafiltration, and viral inactivation and removal
  • Must be a strong leader, able to adapt to daily challenges of manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among subordinates
  • Must be quality focused with knowledge and understanding of cGMP quality systems and how they apply to manufacturing operations
  • Experience in working with the cross-functional teams
  • Experience in troubleshooting and investigation of the critical deviation, and making the risk analysis on the development, technical transfer and process validation

To discover more about this opportunity, apply now or contact Shane Browne at HRM on +353 1 6321827 for a confidential discussion.

Salary: On Application Location: Louth