Contract Manufacturing Site Lead - Ops & PM Expert

Morgan McKinley; Dún Laoghaire; On-site; EUR 150,000 - 180,000; Full time

Job summary

Morgan McKinley is seeking a Contract Manufacturing Senior Manager (Site Lead) for a 12-month contract with only 1 day on site per month in the Dublin region. You will lead operations at the contract site, manage budgets and contracts, and drive continuous improvement across manufacturing processes.

You will collaborate with external CMOs and internal stakeholders to ensure regulatory compliance (cGMP/FDA), lead cross-functional teams, and oversee project transfers and risk management.

Qualifications

• Bachelor's in Business Administration, Engineering, or Science-related field.
• 8+ years in protein, API, DS, DP, or packaging manufacturing.
• 8+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles.
• 5+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products.
• 3+ years of project management experience leading multi-functional and multi-location team.
• 3+ years of experience across ACM or CMQ.
• Ability to travel +/- 20% of time (domestic and international)

Responsibilities

• Manufacturing operations: Develop and lead robust business processes and manage budgets and contracts with contract site management.
• Site performance monitoring: Use lean tools and PDCA; drive improvements and lead site operating reviews.
• Project Management and Technology transfer: Lead projects from conception to implementation; oversee product transfer activities and risk management.
• Communications: Maintain relationships with contract site management and internal executives; escalate issues as needed.

Skills

Project management

Cross-functional leadership

Budget management

Process improvement

Regulatory compliance (cGMP/FDA)

Contract management

Communication and negotiation

Education

Bachelor's in Business Administration, Engineering, or Science-related field

Tools

ACM/CMQ

Job description

Morgan McKinley is seeking a Contract Manufacturing Senior Manager (Site Lead) for a 12-month contract with only 1 day on site per month in the Dublin region. You will lead operations at the contract site, manage budgets and contracts, and drive continuous improvement across manufacturing processes.

You will collaborate with external CMOs and internal stakeholders to ensure regulatory compliance (cGMP/FDA), lead cross-functional teams, and oversee project transfers and risk management.