Associate Director Technical Operations

AbbVie; Westport; On-site; CAD 120,000 - 170,000; Full time

Job summary

AbbVie in Canada is seeking an Associate Director of Technical Operations to lead New Product Introduction programs for Biologics at the site. You will oversee cross-functional teams, drive technology transfers, and ensure compliance with regulatory standards while guiding process improvements in day-to-day production.

The role calls for a strong background in process engineering and NPI leadership, with experience managing engineers/scientists and coordinating regulatory filings across AbbVie

Qualifications

• M.Sc. in a relevant Science area and extensive experience in a hands-on Process Engineering or development for new product introduction.
• Experience leading professional teams that include Engineers and/or Scientists.
• Experience leading product transfer and New Product Introduction projects.
• Regulatory filing experience and familiarity with HA audits.
• Excellent communication and interpersonal skills for interaction with internal departments and AbbVie sites worldwide.
• Computer literacy with knowledge of statistical methods, data analysis and interpretation.

Responsibilities

• 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.
• 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.
• Identify and solve technical problems independently for new products and for commercial operations.
• Plan data collection, organize results and apply statistical methodologies; present information via graphs and reports.
• Evaluate new process equipment and advise management on opportunities in novel technologies.

Skills

People leadership

Project management

New Product Introduction

Process engineering

Regulatory interaction

Education

MSc in a relevant Science area

Tools

Statistical methods

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .

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.

Main duties & responsibilities

• 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.