Technical and Scientific Affairs (TSA) Manager

Team Horizon is seeking a TSA Manager for our client based in Sligo. The Technical and Scientific Affairs (TSA) Manager is a member of the Site Leadership Team and is responsible for executing the technical agenda of the Sligo site, including Technology Transfer, Process Validation, Cleaning Validation, Manufacturing Operations and were required Research and Development Activities. This role is a Technical Leader whereby they must not only have significant professional and academic experience in manufacturing technical and scientific affairs but have the ability not only lead TSA resources but also support Site Leadership peers at the Sligo Manufacturing Site to deliver an expanding and complex technical agenda

Why you should apply:

• This is an opportunity to become an integral part of the Site Quality Assurance team and as a key member you will provide hands on technical support & oversight of Validation activities.
  
  
• Opportunity for flxible & hybrid working as well as competetive salary & benefits
  
  What you will be doing:
  
  
• Deliver the Sligo Technical Agenda. At a high level this includes:
  
  
• Lead, motivate and develop the TSA team that provides technical expertise and technical leadership for investigation and resolution of process deviations, root cause investigation, CAPAs, process improvements, review, and approval of change controls.
  
  
• Provide team leadership - setting work goals, controlling and meeting goals, professional and personal development of team members.
  
  
• Lead problem-solving initiatives.
  
  
• Interaction with National Authorities when required for example on importation of animal origin or pathogen materials.
  
  
• Implementation of new production methods, Technology transfer: Examination of production methods prior to their transfer to production, including validation (when needed).
  
  
• Follow-up and training of production teams.
  
  
• Examining the development processes and adapting them to the registration requirements
  
  
• Input to the leadership team and the ongoing development of the company strategy.
  
  
• Professional support for various subjects on demand.
  
  
• Participating in short and long-term organisational planning and strategy as a member of the management team.
  
  
• Participation in professional forums.
  
  
• Team management - setting work goals, controlling and meeting goals, professional and personal development of team members.
  
  
• Develop functional partnerships with the required site business units to address TSA activity related issues.
  
  
• Actively engage with TSA Peers in other business units and TSA Leadership to share knowledge, challenges and solutions.
  
  
• Develop and maintain the depth of knowledge and commitment to excellence necessary for the manufacture of biological products.
  
  
• Conduct work activities in compliance with Safety, Health and Welfare at Work legislation and Company policies.
  
  
• Engage with and Support Quality and Regulatory Audits.
  
  What you need to apply:
  
  
• At least 10 years experience in the biotechnology and/or pharmaceutical industry, with experience of new product introductions and product support.
  
  
• At least 5years experience in People Leadership with direct and/or matrix reports.
  
  
• Knowledge of the processes and equipment necessary for the manufacture of pharmaceuticals (oral solid dose), parenterals and/or biologicals
  
  
• Experience with vaccines would be preferable particularly in the area of product development and stewardship.
  
  
• Ability to prioritize workload for self and reports to short and near term horizons.
  
  
• Ability to plan for long term horizons for technology, processes and people.
  
  
• Flexible and agile in support of the sites overall goal.
  
  
• Demonstrated ability in coaching and mentoring technical teams, Excellent problem solving (facilitation and application of tools), risk management and decision making skills.
  
  
• Excellent collaboration skills required.
  
  
• Proficient in written and spoken English