QC Planner

PE Global (UK); Leinster; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

PE Global is recruiting for a QC Planner to support a leading multinational biotech client based in Dublin. This 12-month contract role is hybrid and involves managing the Analytical Strategy & Lifecycle (ASL) book of work, developing project plans, timelines, and capacity models across analytical methods and renewal programs.

The role requires strong project management, risk handling, and cross-functional collaboration with SMEs, Regulatory, and Leadership teams to ensure on-time delivery and

Qualifications

• Bachelor’s degree in science or related discipline; 4+ years in the pharmaceutical industry
• Minimum 3 years of project planning/management experience within a GMP manufacturing environment
• Experience with analytical methods used in biologics (iCIEF, HPLC, CE, Bioassay, ELISA, LC-MS)
• Biologics Regulatory experience is a plus

Responsibilities

• Provide analytical project planning and management by maintaining timelines, milestones, and budgets.
• Coordinate cross-functional activities with Analytical SMEs, Regulatory, and Leadership teams.
• Manage capacity forecasting and risk registers for ongoing and upcoming projects.
• Prepare executive progress reports and communicate status to stakeholders.
• Maintain brand operational risk registers and track action items.

Skills

Project management

Risk management

Cross-functional collaboration

Stakeholder communication

Timeline planning

Budget management

Education

Bachelor’s degree in science or related disciplines

Tools

iCIEF

HPLC

CE

Bioassay

ELISA

LC-MS

Job description

PE Global is recruiting for a QC Planner for a leading multinational biotech client based in Dublin. This is an initial 12-month contract, hybrid role.

The Project Manager – Analytical Strategy Planner will be responsible for managing the book of work in the Analytical Strategy & Lifecycle (ASL) team. The planner will develop and manage project plans, timelines, and capacity models for associated projects. The role will involve identifying and responding to critical path barriers, maintaining a risk registry and associated contingency plans, and preparing executive progress reports. The APM is required to work in a cross-functional and dynamic setting where project assumptions and scenarios may change and therefore requires an individual who can quickly adapt to the changes and manage communications at different levels in the organization. Work scope will include planning various projects related to lifecycle of commercial products with project planning responsibilities related to analytical methods, specifications, reference standards, and comparability approaches. This role will work with other project planners and subject matter experts including Analytical SMEs, internal & external Analytical Transfer and Testing team, Analytical Product & Strategy Leads, Regulatory, and the Leadership Team.

Key Responsibilities:

• Provide analytical project planning and management by maintaining timelines, keeping track of major milestones, and ensuring analytical CMC deliverables are met on-time for various brands.
• Define and monitor progress on deliverables and maintain timelines and budgets in alignment with program milestones, leveraging project planning and management best practices.
• Coordinate financial and FTE resource forecasting based on the ongoing analytical book of work and planned future activities.
• Facilitate and communicate project activities with all relevant stakeholders.
• Maintain and update brand operational risk register, track action items against the identified risks, and communicate/document status/resolution periodically
• Manage multiple, medium to high complex cross-functional process improvements in support of Commercialization projects.
• With input from the Analytical Product Leads and Leadership team, lead the development of integrated timelines and book of work, ensuring that alignment with Global Project timelines.
• Serve as a member of analytical sub-teams coordinating harmonized operational ways of working across brands, tracking timeline elements to ensure that functional deliverables are completed on time and according to relevant quality standards.
• Ensure adherence to applicable project budgets and propose capital appropriation requests where applicable.
• Proactively identify program risks and work with the team and team leader to develop contingency plans.
• Responsible for the preparation of routine status reports and communicate project progress to the various stakeholders.
• Ensure that team recommendations related to project direction and timelines which need endorsement by governance teams are planned for review at appropriate milestones
• Effectively manage day to day operational activities for the team, such as routine brand report dashboard, departmental and brand book of work review meetings, Quality metrics for the team, management of brand repository platforms etc.

Qualifications & Experience

• Excellent knowledge of, and competency in, project management processes, including planning, resource planning and allocation, and risk and issue management.
• Excellent organizational and time management skills
• Strong analytical, problem-solving, and critical thinking skills
• Must be able to interact and communicate effectively at all levels of the organization
• High attention to detail skills
• High organization skills with ability to multi-task several objectives in parallel
• People and project management skills

Education/Experience/ Licenses/Certifications:

• A bachelor’s degree in science or related disciplines with at least 4+ years’ experience in the pharmaceutical industry
• Minimum 3 years of project planning/management experience within a manufacturing GMP environment
• Experience and/or understanding of analytical methods commonly applied to biologics (iCIEF, HPLC, CE, Bioassay, ELISA, LC-MS, etc.).
• Biologics Regulatory experience is a plus

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