Contract Manufacturing Manager

PE Global; Dublin; On-site; EUR 120,000 - 160,000; Full time

Job summary

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

The role focuses on developing and leading robust business processes, managing budgets and contracts with CMOs, and driving site performance improvements across contract sites, including technology transfer and risk management. Travel may be required.

Qualifications

• 8+ years in protein, API, DS/DP, or packaging manufacturing.
• 8+ years with cGMP principles and FDA/regulatory guidance.
• 5+ years working with external parties and cross-functional teams.
• 3+ years leading multi-location projects.
• 3+ years experience across ACM or CMQ.

Responsibilities

• Develop and lead robust contract site processes.
• Manage budget development, forecasting and contracts with CMOs.
• Monitor site performance using lean tools and PDCA.
• Lead product transfer projects from conception to implementation.
• Coordinate planning for product transfers and risk management.

Skills

Budget management

Project management

Cross-functional leadership

Lean tools

PDCA

Change management

Stakeholder communication

Education

Bachelor’s degree

Science/Engineering background

Job 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***