Manufacturing Technical Lead – Team Horizon
 
We are now recruiting a Manufacturing Technical Lead to join our client’s diverse Biologics Operations team in Co. Sligo.
 
As the new Manufacturing Technical Lead, you will provide operations technical leadership support to all Biologics manufacturing operations and lead NPI activities throughout the pharma site. Your primary function being an operations professional who with subject matter expertise in the area of biologics, applies their aseptic, sterile and process knowledge to support operations to ensure that the organization is suitably placed to achieve the strategic goals.
 
Why you should apply:
 

• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
• The role is generously compensated, and attracts a competitive base salary and highly attractive benefits package.
• Excellent career progression opportunities.

 
What you will bedoing:
 

• Lead the internal technical transfer manufacturing requirements from scale-up of biological processes from process development into clinical / commercial manufacturing.
• Lead a team to provide ownership for investigation and resolution of process deviations, root cause investigation, CAPAs, process improvements, review and approval of change controls
• In collaboration with the Operations Lead, you will be the subject matter expert for all manufacturing operations in biologics and sterile/aseptic processing embracing all the phases of the process (cleaning, formulation, filling, visual inspection, etc)
• In collaboration with the Operations Lead, mentor and drive the operations group to be able to become experts on the equipment, process and regulatory requirements.
• Provide direct interface as a subject matter expert with QA department to interaction with HPRA, FDA and applicable health authority and internal audits.
• Collaborate with the Operations lead and his team to drive continuous improvement and strategic capital projects
• Support processing via in-plant coverage and troubleshooting process deviations, as well as identifying opportunities for process improvements
• Provide required technical guidance for SOP’s required for manufacturing.
• Compile data from manufacturing, performing statistical analysis to trend and track process performance, culminating in campaign summary.
• Actively participate in an environment which fosters safety, quality and continuous improvement in cost and customer service
• Responsible for compliance with applicable policies and procedures.  Ensures quality and effectiveness of key results of major projects within function through sound design, early risk assessments, and implementation of fall-back strategies

What you need to apply:
 

• You will have a Bachelor’s Degree in engineering, science or closely related discipline, Masters preferred
• Extensive experience (10+ years) in biologics or sterile manufacturing, supply chain management, engineering, quality and/or drug development with 8+ years of significant engineering and/or operational experience. (A post-graduate program/course may contribute towards the desired years of experience)
• Interacts well with diverse groups within engineering and manufacturing while maintaining strong working relationships with internal and external collaborators