Contract Manufacturing - Senior Manager

Berkley Group; Dublin; On-site; EUR 120,000 - 180,000; Full time

Job summary

Berkley Group, a global biotechnology company based in south Dublin, Ireland - seeking a Snr. Contract Manufacturing Manager on a 12+ month contract with possible extension.

The role centers on manufacturing operations, building robust processes, and managing contract site relationships for optimal performance. The ideal candidate has a BS in a related field and 8+ years in protein/API/DS/DP or packaging, with strong cGMP knowledge and regulatory experience, plus 3+ years leading

Qualifications

• Bachelor's degree in a relevant field and 8+ years in protein/API/DS/DP or packaging manufacturing.
• 8+ years with cGMP principles and regulatory guidelines.
• 5+ years liaising with external parties and leading cross-functional teams.
• 3+ years in multi-functional and multi-location project leadership.
• 3+ years across ACM or CMQ environments.
• Willingness to travel up to ±20%.

Responsibilities

• Manufacturing operations oversight across contract sites and CMOs.
• Develop and lead robust business processes; manage site relationships.
• Monitor industry trends to improve site performance and capacity.
• Lead budgeting, contracts, and forecasting related to transfers.
• Drive operational excellence, PDCA, and site issue resolution.

Skills

Protein/API/DS/DP

cGMP knowledge

Regulatory compliance

Cross-functional leadership

Project management

ACM/CMQ experience

Travel readiness

Education

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

Job description

Global Biotechnology company based in south Dublin, Ireland - looking for Snr. Contract Manufacturing Manager.

This position is 12+ month contract with possible contract extension.

The Job:

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.

Have You:

• Bachelors 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)

The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.