Technical Operations Manager

Technical Operations Manager

We are currently hiring a Technical Operations Manager to join our leadership team in Ballytivnan, Sligo. The successful candidate will be a member of the Site Leadership Team with responsibility for leading the Technical Operations function on site, including but not limited to:

• Support for commercial manufacturing operations including technical investigations, process updates and process improvements for ADC Conjugation, Non Potent Parenteral Vial Filling and ADC Vial Filling.
• Planning for and Leadership of new product introductions for the site including technical transfers, process establishment and providing technical oversight across ADC Conjugation, Non Potent Parenteral Vial Filling and ADC Vial Filling.
• Strategic Leadership of the Technical Operations department to complete manufacturing activities in a highly technical and regulated Biopharma manufacturing facility, ensuring continued compliance with HR, Quality, Engineering, Safety and Finance policies.
• Partnership with Research and Development, External Contract Manufacturing and Product Development, Science and Technology to evaluate potential new products for the site including process fit assessments and establishment of new equipment requirements.
• Identification and development of continuous improvement projects
• Ownership of the Department including HR planning and performance measurement, people development and financial budget establishment and management
• Member of the SLT contributing to the effective running of the site through proactive involvement and contribution to Site Leadership (Safety, Quality, Product Delivery, Finance, Strategy, and Culture)

Qualifications:

• Masters and/or PhD qualification in Science/Engineering
• Minimum of 7 years background in biopharmaceutical processing, with relevant experience of process development, batch processing, technical transfers, commissioning and validation in the pharmaceutical industry.
• Detailed knowledge of sterile manufacturing processes and operations
• Knowledge of antibody drug conjugates (ADCs)
• Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required. A minimum of 7 years' experience of start-ups and/or new product introductions to pharmaceutical facilities. Must be able to lead these activities in a start-up environment.
• 7 years of demonstrated process development skills, including the ability to deliver innovative manufacturing processes at industrial scale.
• Proven scale up skills, to facilitate the successful transition from laboratory to full scale production.

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