CMO Sr Manager

PE Global; Dublin; On-site; EUR 110,000 - 150,000; Full time

Job summary

PE Global is recruiting a Contract Manufacturing Senior Manager for a leading biotech company based in Dublin South. This is an initial 12-month contract role.

Responsibilities include developing robust business processes, managing budgets and contracts, and driving site performance with lean tools and PDCA. The role also covers cross-functional leadership, project management, and successful product transfers to contract sites, with travel up to 20%.

Qualifications

• Bachelor’s degree in business, engineering or science-related field.
• 8+ years in protein, API, DS/DP, or packaging manufacturing.
• 8+ years knowledge of cGMP, FDA and other regulatory guidelines.
• 5+ years working with external parties and leading cross-functional teams.
• 3+ years of project management across multi-location teams.
• 3+ years experience across ACM or CMQ.
• Willingness to travel ±20% domestically and internationally.

Responsibilities

• Develop and lead robust contract manufacturing processes with contract site management.
• Oversee budget development, monitor costs, and manage contracts with CMOs; forecast to sites.
• Monitor site performance with lean tools and PDCA; lead site operating reviews and improvements.
• Lead department-wide projects from conception to implementation and close-out.
• Coordinate product transfers to contract sites; manage timelines, budgets and risk.

Skills

Project management

Budget management

Cross-functional leadership

Lean manufacturing

Process improvement

Education

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

Job description

Description

PE Global is currently recruiting for a Contract Manufacturing Senior Manager on behalf of a leading biotech company based in Dublin South. This is an initial 12-month contract role.

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.

Education / Experience

• 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)

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***