Position Details

EDUCATION

• Minimum of a Masters degree in a technical discipline (e.g. biochemistry, chemistry, biotechnology, biopharmaceuticals). 
• PhD. is desirable.

EXPERIENCE

• 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 reports.
• Knowledge of the processes & equipment necessary for the manufacture of pharmaceuticals (oral solid dose), parenterals and/or biologicals.
• Experience with vaccines would be preferable.
• Ability to prioritize workload for self.
• Ability to plan for long term technology, processes & people. 
• Demonstrated ability in coaching & mentoring technical teams.
• Excellent problem solving, risk management & decision making skills.
• Excellent collaboration skills.
• Proficient in written & spoken English.  

RESPONSIBILITIES

• Deliver the Sligo Technical Agenda. At a high level this includes:
  • Lead, motivate & develop the TSA team that provides technical expertise & technical leadership for investigation & resolution of process deviations, root cause investigation, CAPAs, process improvements, review, and approval of change controls.
  • Interaction with National Authorities when required.
  • Implementation of new production methods, Technology transfer: Examination of production methods prior to their transfer to production, including validation (when needed). Follow-up & training of production teams.
  • Examining the development processes & adapting them to the registration requirements.
  • Input to the leadership team & the ongoing development of the company strategy.
  • Professional support for various subjects on demand.
  • Participating in short & long-term organisational planning as a member of the management team.
  • Team management - setting work goals, controlling and meeting goals, professional & 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 & maintain the depth of knowledge & commitment to excellence necessary for the manufacture of biological products.
  • Conduct work activities in compliance with Safety, Health and Welfare at Work legislation & Company policies.
  • Support Quality and Regulatory Audits. 

CORE COMPETENCIES

• Strong leadership skills.
• Ability to delegate tasks & projects. 
• Project management skills highly desirable. 
• Proactive at keeping current with literature & latest technologies.
• An excellent understanding of GMP, ICH & compendia regulations and guidance's.
• Demonstrated ability in leading root cause analysis & effective investigation practices.