Biologics Launch Readiness Lead

Msd Ireland; Dunboyne; On-site; EUR 130,000 - 180,000; Full time

Job summary

MSD Ireland's Dunboyne facility is seeking a Launch Readiness Lead (AD Ops) to oversee all aspects of new product introduction and launch readiness for biologics products. You will lead cross-functional teams, manage capital projects, and align with global Launch Readiness to ensure timely filings and launches while maintaining quality and safety.

You will drive site and above-site activities, develop implementation strategies, coordinate stakeholders, and contribute to launch excellence with

Qualifications

• Bachelor’s degree required in a technical discipline related to pharma manufacturing.
• Minimum 5 years cross-functional leadership experience.
• Strong stakeholder management and communication skills.
• Proven ability to manage capital projects and drive launch readiness.
• Knowledge of cGMP, GDP and regulatory compliance.

Responsibilities

• Drive site and above-site activities to deliver launch milestones and filings.
• Define and deliver related capital projects on time, within budget, with quality & safety.
• Coordinate cross-functional teams across analytics, capital projects, finance, process eng., tech transfer, validation, regulatory filing.
• Communicate effectively with global and local stakeholders and the transfer core team.
• Represent launch readiness in Site Leadership Team, NPI council, and governance meetings.
• Share best practices and maintain a holistic schedule for launch readiness activities.

Skills

Leadership

Cross-functional collaboration

Project management

Stakeholder management

Communication skills

Lean Six Sigma

GMP/cGMP knowledge

Biologics manufacturing

Education

Bachelor’s degree

Tools

Microsoft Office

Job description

MSD Ireland's Dunboyne facility is seeking a Launch Readiness Lead (AD Ops) to oversee all aspects of new product introduction and launch readiness for biologics products. You will lead cross-functional teams, manage capital projects, and align with global Launch Readiness to ensure timely filings and launches while maintaining quality and safety.

You will drive site and above-site activities, develop implementation strategies, coordinate stakeholders, and contribute to launch excellence with