Contract Manufacturing Manager

Morgan McKinley; Dublin; On-site; EUR 120,000 - 170,000; Part time

Job summary

Morgan McKinley is seeking a Senior Contract Manufacturing Manager (Site Lead) to develop and lead robust business processes across contract sites in Ireland. You will manage budgets, contracts, forecasts and capacity planning while driving operational excellence and change.

You will lead cross-functional projects from conception through transfer, present to senior management, and ensure risk is managed per RM plans. Travel up to 20% domestically and internationally.

Qualifications

• 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.
• 3+ years of project management experience leading multi-functional and multi-location team.
• Ability to travel +/- 20% of time (domestic and international).
• Promotes and drives organizational change.

Responsibilities

• Manufacturing operations: Develop and lead robust business processes, maintain relationships with contract site management, monitor budget and forecasts, and manage contracts.
• Site performance monitoring: Use lean tools and PDCA to drive improvements and maintain contract site health; communicate with internal management.
• Project Management and Technology transfer: Lead department-wide projects from conception to implementation, manage product transfers, budgets, timelines, and RM risk plans.

Skills

Project management, cross-functional

Leadership

Negotiation

Problem solving

Risk management

Proactiveness

Multitasking

Education

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

Job description

Senior Contract Manufacturing Manager - 12 Months - 1 day per month

Contract Manufacturing Senior Manager (Site Lead)

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)
• 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