Manufacturing Lead (API)

  • Location

    Dublin North, Dublin

  • Sector:


  • Job type:


  • Salary:


  • Contact:

    Jack Conway-Kenny

  • Contact email:

  • Job ref:


  • Published:

    over 1 year ago

  • Expiry date:


Manufacturing Operations Shift Lead

4 Cycle (24/7)

SK biotek Ireland is seeking to recruit 4 cycle (24/7) Manufacturing Operations Shift Team Lead join the Manufacturing Operations Department.

Reporting to the Shift Manager, the successful candidate is responsible for ensuring the Process area operates in safe and GMP compliant manner at all times. A key responsibility of this position is to develop and performance manage a team of process chemists and/or chemical process operators. The role will be to build upon and improve existing process design to optimize process, facility and equipment use while conforming to SOPs and cGMP requirements.

Key Responsibilities

  • Lead/develop the team to ensure safe and timely completion of all process activities (GMP)
  • Coordinate the workload of your team in order to meet schedules and timelines.
  • Lead any Safety Investigations from your area identify and implement CAPA's.
  • Mentor and coach your team in order to drive full performance and development.
  • Set performance goals and objectives for team and conduct performance appraisals.
  • Work with the Shift Team Leads/Shift Manager (Shift Leadership Team) and track area progress on key issues.
  • Drive Shift Metrics for your team.
  • Fully Support all New Product Introduction (NPI) activities, to ensure RFT introduction of new products.
  • Participate in and attend cross-functional (multidiscipline) meetings.
  • Lead project-related working groups (cross-functional) in order continuously improve process and performance, with specific focus on Human Error reduction.
  • Lead investigations and corrective action follow-up to ensure closure of events/investigations in line with department metrics.
  • Act as interface between management team and functional team.
  • Assist with the creation and maintenance of area SOPs and validation documents for equipment and procedures, and assist in the writing of area status reports, regulatory documents, and process descriptions.
  • Drive implementation and embedding of Lean Tools in the area (Standard Work, 5S, Yellow Belt)
  • Please note this position will be non-unionised.


  • Prior relevant team leadership experience in a regulated manufacturing operations environment.
  • 5+ years of working experience in a regulated manufacturing environment.
  • Working knowledge of production operations, scheduling, design, planning, etc.
  • Knowledge of lean management systems.
  • Previous experience defining and establishing policies and SOPs.
  • Excellent leadership, communication, and interpersonal skills.
  • An ability to work independently and as a member of a team in a dynamic, fast-paced and goal driven environment.