Contract Manufacturing Manager

Aphex Group; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

Aphex Group in Ireland is seeking an experienced manufacturing operations leader to develop and implement robust business processes across contract sites. You will manage budgets, contracts, and forecasting, and collaborate with site management to drive performance improvements.

The role emphasizes lean methods, PDCA, and cross-functional teamwork to ensure seamless product transfers and regulatory compliance.

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)

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.
• 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: not used in this field
• Competencies: not used in this field

Skills

Leadership

Cross-functional collaboration

Budgeting

Forecasting

Change management

Negotiation

Problem solving

Risk management

Project coordination

Lean PDCA

Education

Bachelor's in Business Admin

Job description

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 organisationally savvy
• Promotes and drives organisational 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