Associate Director, Data Analytics

Caraway Therapeutics, Inc.; Carlow; Hybrid; EUR 120,000 - 160,000; Full time

Job summary

Caraway Therapeutics, Inc. in Carlow, Ireland is seeking an Associate Director of Data Analytics to lead digitalisation of manufacturing data.

The role reports to the Technical Operations Commercial Process Lead and works with NPI, Validation and IPT teams to establish analytics standards and drive data-driven decisions. The role requires deep data analytics expertise, Lean Six Sigma training, and familiarity with MES, DeltaV, SAP, LIMS and PI systems.

Qualifications

• Bachelor's degree or higher in a science, engineering or technical discipline preferred.
• Experience in data analysis and data integrity within a GMP manufacturing setting.
• Lean Six Sigma method experience desirable.
• Strong knowledge of data analytics tools and visualization.
• Ability to manage complex, multi-disciplinary projects.

Responsibilities

• Serve as data analytics SME at site meetings for digitalisation projects in Carlow.
• Perform data analysis and provide informed recommendations.
• Conduct statistical analysis to support development and commercialisation batches.
• Provide SME input into investigations and quality notifications.
• Drive continuous improvement using Lean Six Sigma methodologies.
• Lead and participate in projects, failure investigations and Kaizen events.
• Perform root cause analysis and implement corrective actions.
• Ensure compliance with cGMP, policies, and regulatory requirements.

Skills

Data analysis

Lean Six Sigma

Project management

GMP awareness

Data integrity

Education

Bachelor's degree or higher

Tools

Power BI

Spotfire

Shiny

MES

DeltaV

SAP

LIMS

PI

Job description

Job Description

A new exciting Associate Director - Data Analytics opportunity exists within the Technical Operations group in Carlow.

Reporting to the Technical Operations Commercial Process Lead, you will lead digitalisation projects in relation to manufacturing data at Carlow and align digitalisation efforts working closely with New Product Introduction, Validation and IPT Teams. You will be the Data Analytics Subject Matter Expert (SME) at the our site.

Responsibilities

• Serve as data analytics engineering Subject Matter Expert (SME) at above site meetings for digitialisation projects at Carlow.
• Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
• Statistical data analysis to support development and commercialisation batches.
• Provide SME technical input into quality notification by authoring/reviewing/approving investigations.
• Support continuous improvement through Lean Six Sigma methodologies
• Lead and active participation in projects, system failure investigations and investigation reports,
• Contribution to Kaizen events as appropriate
• Perform root cause analysis of substandard performance, using standard tools and methods
• Implement subsequent corrective action through the change management system.
• Serve as data analytics engineering representative at above site meetings.
• Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
• Work collaboratively to drive a safe and compliant culture in Carlow.

Required Skills

• Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
• Data analysis experience required
• Prior related work experience; in manufacturing, in a GMP Setting with strong focus on data integrity, data/statistical analysis, digitialisation initiatives
• Lean Six Sigma Methodology experience desired
• Subject Matter Expert level knowledge of data analysis visualization tools such as Power BI, Spotfire or Shiny etc. is required.
• Knowledge of manufacturing applications such as MES, DeltaV, SAP, LIMS and PI
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
• Sterile filling processes and equipment
• Understand the specific responsibilities of all Carlow departments as they relate to one’s own department, understanding the business processes one’s department supports
• Ability to effectively manage complex projects across multiple disciplines.

About the Site

Our facility in Carlow site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines, biologics and small molecule drug product. Since its initial launch, the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities, laboratories and temperature-controlled warehousing units. The Carlow site is a significant employer in the South East region and attracts high performing talent through close collaborations with universities and colleges in the region.

Company Values

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

Working Conditions

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

Job Details

• Employee Status: Regular
• Flexible Work Arrangements: Not Applicable

Job Posting End Date

10/30/2026