Senior Director, Sterile Manufacturing Operations

Caraway Therapeutics; Carlow; Hybrid; EUR 180,000 - 280,000; Full time

Benefits offered by this job

Hybrid working model

Job summary

Caraway Therapeutics in Carlow is seeking an Operations Director to lead a high-potency, multi-product sterile manufacturing facility with around 50 staff. You will drive safety, quality, delivery, and people priorities while guiding regulatory milestones and new product introductions in a dynamic environment.

You will shape strategy, coach teams, and build a high-performing, agile culture across Operations, Quality, Engineering and Technical functions to deliver milestones and continuous

Qualifications

• Significant leadership experience within sterile drug product manufacturing operations.
• Experience leading manufacturing organisations through regulatory inspections and major milestones.
• Experience supporting new product introduction, commercialisation and operational readiness.

Responsibilities

• Lead a large cross-functional manufacturing organisation driving safety, quality, delivery and people priorities.
• Oversee introduction and commercialisation of multiple new products in a sterile environment.
• Drive operational and technical excellence with robust and reliable manufacturing performance.
• Lead regulatory and inspection readiness activities across the manufacturing organisation.
• Develop and execute integrated plans to deliver product, manufacturing and regulatory milestones.
• Identify and mitigate operational, technical and quality risks with timely decisions.
• Drive continuous improvement across the high-potency operation and challenge established practices.
• Provide strategic direction and alignment across Operations, Quality, Engineering and Technical teams.
• Build, coach and develop a high-performing team with accountability and agility.

Skills

Sterile manufacturing

Cross-functional leadership

Regulatory inspections

NPI readiness

Risk management

People development

Change leadership

Communication

Agile leadership

Education

Science or Engineering degree

Job description

Caraway Therapeutics in Carlow is seeking an Operations Director to lead a high-potency, multi-product sterile manufacturing facility with around 50 staff. You will drive safety, quality, delivery, and people priorities while guiding regulatory milestones and new product introductions in a dynamic environment.

You will shape strategy, coach teams, and build a high-performing, agile culture across Operations, Quality, Engineering and Technical functions to deliver milestones and continuous