Position Details

EDUCATION

A minimum of a Honors Bachelors degree in a technical discipline (e.g. biochemistry, chemistry, biotechnology, biopharmaceuticals). Advanced degrees such as MSc. and PhD. are desirable.

EXPERIENCE
At least 5 years experience in the biotechnology and/or pharmaceutical industry, with experience of new product introductions and product support.  
Knowledge of the processes and equipment necessary for the manufacture of pharmaceuticals (oral solid dose), parenterals and/or biologicals
Experience in authoring, review and execution of validation studies and reports is a must.
Experience with vaccines would be preferable particularly in the area of product development and stewardship.
Ability to prioritize workload for self and reports.
Flexible and agile in support of the sites overall goal.
Demonstrated ability in leading root cause analysis and effective investigation practices.
Excellent problem solving (facilitation and application of tools), risk management and decision making skills.
Excellent collaboration skills required.
Proficient in written and spoken English.  

RESPONSIBILITIES
Deliver the Sligo Technical Agenda. At a high level this includes:
Lead, motivate and develop the TSA team and 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.
High level of on the floor activity day to day to support production issues. 
Lead product related problem-solving initiatives – be inquisitive. 
Understand science of process incl process flows, CPP’s, historical failures.
Conduct process monitoring/trending.
Support QA with generation and closure of annual product reviews.
Use Continuous improvement tools for incremental change.
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.
As required input to the leadership team and the ongoing development of the company strategy.

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. 

CORE COMPETENCIES
Ability to breakdown and assign workload of complex tasks and projects. 
Project management skills highly desirable. 
Proactive at keeping current with literature and latest technologies.
An excellent understanding of GMP, ICH and compendia regulations and guidance's.
Demonstrated ability in leading root cause analysis and effective investigation practices.
Excellent problem solving (facilitation and application of tools), risk management and decision making skills
Excellent collaboration skills.
Excellent attention to detail and significant data review experience essential.
Excellent technical writing skills including deviation reports and validation reports.
Effective time management and multi-tasking skills.
Demonstrate ability to drive the completion of tasks, trouble shooting skills and excellent attention to detail.
Excellent communication skills, both verbal & written.