Associate Director Technical Operations

AbbVie; Westport; On-site; EUR 80,000 - 100,000; Full time

Job summary

AbbVie is seeking an Associate Director of Technical Operations in Westport, Ireland. This role involves leading New Product Introduction Programs for Biologics and driving Drug Product Technology transfers to manufacturing while ensuring compliance with regulations.

The ideal candidate will have a Master’s degree in a relevant Science area and substantial experience in Process Engineering, including managing teams and leading product transfers. Excellent communication skills are essential.

Qualifications

• M.Sc. in a relevant Science area and extensive experience in Process Engineering or development for new product introduction.
• Experience managing and leading professional teams including Engineers or Scientists.
• Experience in product transfer and New Product Introduction projects.
• Familiarity with regulatory filing and HA audits.
• Excellent communication and interpersonal skills for interaction with internal departments and other AbbVie sites.

Responsibilities

• Lead personnel responsible for New Product Introduction Programs.
• Drive Drug Product Technology transfers to manufacturing.
• Provide technical guidance and support for production issues.
• Evaluate new process equipment and advise on innovative applications.
• Ensure compliance with environmental, health, and safety requirements.

Skills

Process Engineering

Team Leadership

Regulatory Compliance

Communication Skills

Statistical Methods

Education

M.Sc. in a relevant Science area

Job description

Job Description

The Associate Director Technical Operations will report to the Director of the Tech Ops business unit and be responsible for the Site New Product Introduction Programs. This position has responsibility for providing direct oversight, management, and leadership with minimal technical or administrative guidance, as well as responsibility for all aspects of technical process support such as but not limited to project management, process monitoring and validation programs within the site.

This includes leadership of in-line product support for processes, project definition and demonstration, and process improvements/productivity while assuring compliance with regulatory agencies. These activities involve economic feasibility studies toward objectives assigned or approved by site leadership.

• Lead personnel (team of 7-9) responsible for New Product Introduction Programs of the site for Biologics.
• Drive Drug Product Technology transfers to manufacturing, including the financial aspects of each project.
• Provide technical guidance and continuous improvement support for commercial and new product introductions on day-to-day production and processing issues: problem solving, deviations, manufacturing documentation changes, etc.
• Source for plant consistency across the Division, share problem‑solving activities, and maintain updated technical product history.
• Provide technical assistance with the implementation of changes in manufacturing equipment, batch size, ingredient supplier and experimental batches as needed. Ensure that products and processes are kept in compliance with validation requirements.
• Identify and solve technical problems independently for new products and for commercial operations.
• Plan data collection organizes results and applies statistical methodology. Presents numerical information through computer readouts, graphs, charts and tables, written reports and/or other methods.
• Evaluate new process equipment and advises management about areas of opportunity in the application of novel technologies.
• Implement at plant level global technical initiatives as: new technologies, suppliers, methods, etc. and provide tactical perspectives.
• Assure fulfilments of environmental, health, and safety (EH&S) requirements and compliance obligations, promote continuous improvement, and consider EH&S aspects during the design and change process.

Qualifications

• M.Sc. in a relevant Science area and extensive experience in a “hands on” Process Engineering or development for new product introduction position.
• Experience of managing and leading professional teams that include Engineers and or Scientist personnel.
• Experience leading product transfer and New Product Introduction projects.
• Regulatory filing experience as well as familiarity with HA audits.
• Excellent communication and interpersonal skills for interaction with both internal departments and other AbbVie sites worldwide (QA, Validation, IS, EHS, R&D, S&T).
• Computer literate with knowledge of statistical methods, data assimilation and interpretation.
• Capable to positively influence department employees and/or contributors from other disciplines or peers of higher managerial levels to obtain decision approvals for critical courses of action, either exception or planned.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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