CMC- Project Manager

Next Generation; Dublin; On-site; EUR 70,000 - 90,000; Full time

Job summary

Next Generation in Ireland is seeking a Project Manager / Analytical Strategy Planner to lead cross‑functional programs in biologics, coordinating Analytical, Testing, Regulatory and Leadership teams to meet timelines and priorities. You will manage project plans, resources, and deliverables while navigating changing priorities across brands.

The role requires a science-based bachelor’s degree with 4+ years in pharma, and at least 3 years of project planning or GMP manufacturing experience.

Qualifications

• Bachelor's degree in science or related discipline
• 4+ years in the pharmaceutical industry
• 3+ years' project planning or management in GMP manufacturing
• Experience with analytical methods used in biologics (iCIEF, HPLC, CE, Bioassay, ELISA, LC-MS)
• Strong organisational, analytical and communication skills
• Biologics regulatory experience is an advantage

Responsibilities

• Managing timelines and tracking milestones to keep analytical CMC deliverables on schedule across brands
• Coordinating financial and FTE resource forecasting for the ongoing book of work
• Maintaining the brand operational risk register and tracking resolution of action items
• Leading the development of integrated timelines aligned to Global Project milestones
• Working across analytical sub-teams to harmonise ways of working across brands
• Preparing routine status reports and communicating progress to stakeholders
• Identifying risks early and building contingency plans
• Running day-to-day operational activities: dashboards, book of work reviews, quality metrics and repository management

Skills

Project management

Cross-functional coordination

Analytical skills

Regulatory knowledge

Communication

Education

Bachelor's degree in science or related discipline

Tools

iCIEF

HPLC

CE

Bioassay

ELISA

LC-MS

Job description

This is a Project Manager / Analytical Strategy Planner role within a biologics company, responsible for managing project timelines, resources, capacity and analytical activities across commercial products. You'll coordinate cross-functional teams including Analytical, Testing, Regulatory and Leadership, ensuring projects stay on track while managing changing priorities and deliverables.

Key responsibilities:

• Managing timelines and tracking milestones to keep analytical CMC deliverables on schedule across brands
• Coordinating financial and FTE resource forecasting for the ongoing book of work
• Maintaining the brand operational risk register and tracking resolution of action items
• Leading the development of integrated timelines aligned to Global Project milestones
• Working across analytical sub-teams to harmonise ways of working across brands
• Preparing routine status reports and communicating progress to stakeholders
• Identifying risks early and working with the team to build contingency plans
• Running day-to-day operational activities: dashboards, book of work reviews, quality metrics and repository management
• A bachelor's degree in science or a related discipline, with 4+ years in the pharmaceutical industry
• At least 3 years' project planning or management experience in a manufacturing GMP environment
• Experience with, or understanding of, analytical methods used in biologics (iCIEF, HPLC, CE, Bioassay, ELISA, LC-MS)
• Strong organisational, analytical and communication skills, with the ability to manage several priorities at once
• Biologics regulatory experience is an advantage