Demo

Manufacturing Operations Lead

Mallinckrodt
Dublin, CA Full Time
POSTED ON 3/7/2025
AVAILABLE BEFORE 6/7/2025

Job Title

Manufacturing Operations Lead

Requisition

JR000014722 Manufacturing Operations Lead (Open)

Location

Dublin, IRL

Additional Locations

Job Description Summary

The Manufacturing Operations Lead is responsible for providing support and leadership to the Manufacturing Operations Team in the College Park Manufacturing Facility (CPMF) to manufacture to the required safety, quality, and schedule and cost requirements to meet the business needs. You will work in partnership with Warehouse, Quality, Engineering and EHS to meet the CPMF objectives. The role will include but not be limited to executing manufacturing activities, building upon and improving existing process design to optimise process, facility and equipment use while conforming to SOPs and cGMP requirements.

Job Description

Essential Functions

  • Ensure timely completion of plant operations, safe operations, attention to detail, and good documentation skills. Directly oversees and participates in daily cGMP operations in a cGMP environment.
  • Ensure safety standards and policies are maintained and enforced. Be a role model for these expected behaviors.
  • Manage the finite schedule for manufacturing and integrating cross functional work with engineering, microbiology, calibrations and GMP cleaning.
  • Coordinate the workload of the team of 9 operators in order to meet schedules and timelines.
  • Assist in the development of performance goals and objectives for team.
  • Mentor and coach team in order to ensure full performance potential.
  • Act as interface between management team and functional team.
  • Participates in and attends cross-functional (multidiscipline) meetings when required.
  • Resolve issues within area of control to ensure smooth running of manufacturing area
  • Write deviation notifications when required by cGMP and / or SOP. Coordinate investigations and corrective action follow-up to ensure closure.
  • Reviews and approves area procedures, including SOP's, master batch documentation, change controls, and validation protocols / reports.
  • Leads project-related working groups (cross-functional) in order to troubleshoot any issues and to generate policies, etc.
  • Supports inventory functions occurring in day-to-day business operations between manufacturing and material management
  • Work with the planning and warehouse function to coordinate the timely receipt and / or release of materials to meet production needs.
  • Network with all Area Leads and track area progress on key issues.
  • Acts as designee / point of contact for Operations Manager when required.
  • Participate in Ad hoc projects, goals and objectives as they arise
  • This is not a shift-based role but will require flexibility on occasions.

Minimum Requirements

Education / Experience / Skills :

  • Requires BS / BA in Life Sciences or related field with 5 years of relevant cGMP manufacturing experience.
  • People management skills with experience of leading a team in a cGMP manufacturing environment
  • Experience working in a Grade C / D environment
  • Experience in planning and scheduling of unit operations.
  • Experience in Non-conformance initiation and investigation
  • Ability to work in a team-based environment
  • Ability to manage a wide range of specific tasks
  • Excellent organizational and coordination skills
  • Experience with SAP ERP system an advantage
  • Good interpersonal and communication skills, verbal and written.
  • Thorough, diligent, good attention to detail
  • Collaborator with strong levels of engagement with individuals and team
  • An ability to work independently and as a member of a team in a complex, fast-paced and goal driven environment.
  • High level of delivery and work completion
  • Strong decision-making capability.
  • Demonstrated ability to lead change
  • Working knowledge of six sigma and Lean Tools
  • Ability to build a culture of positive engagement.
  • Organizational Relationship / Scope :

    Reporting to the Operations Manager.

    Working Conditions :

    As per standard contract and Dublin College Park attendance and Timekeeping Policy and Hybrid Working Policy - Dublin College Park

    Disclaimer :

    The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

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