Senior Manager Contract Manufacturing

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

Contract Manufacturing Senior Manager (Site Lead) - 1 day per month onsite - 12 month contract

Responsibilities:

Manufacturing operations: Develop and lead robust business processes, maintain reliable relationships with contract site management; assess industry trends, internal network, and technology advancements as tools to improve contract site performance. Manage budget development, monitoring, and reporting; create and manage contracts - confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.; monitor and improve financials with CMO; actively manage and communicate forecasts to the sites and manage capacity planning. Drive operational excellence and champion change.

Site performance monitoring: Manage contract site performance using lean tools and PDCA, lead site operating review meetings; drive improvements at contract sites; sustain and improve the overall health of the business, and lead communication/relationship with the contract site as well as internal management.

Project Management and Technology transfer: Lead a department-wide project from conception to implementation and close-out. Present to and obtain buy-in for value proposition of such projects to senior management. Provide oversight of all planning and coordination of product transfer activities to the contract site(s); develop, present, and obtain approval of budget, timeline and ensure execution of transfer team activities to achieve seamless product transfer to the contract site(s); ensure risk management initiatives are taking place as per RM plan; lead site issue management and resolution; provide issue escalation to executive management.

Preferred Qualifications:

• Bachelor's in Business Administration, Engineering, or Science-related field
• 8+ years of experience in protein, API, DS, DP, or packaging manufacturing environment
• 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)

Competencies:

• Assimilates multiple inputs and allocates resources to potentially conflicting priorities
• Anticipates and resolves complex problems and integrates into continuous improvement
• Establishes and manages business budget
• Strong influence and negotiation skills
• Expertise in problem solving and risk-based decision-making
• Demonstrated matrix management and organizationally savvy
• Promotes and drives organizational change
• Excellent project management skills
• Mastery of contractual requirements
• Demonstrated ability to lead effectively in collaborative/team environment
• Demonstrated ability to take initiative, drive action, and works independently