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MINIMUM REQUIREMENTS
* 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 5 years 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.
* 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.
* Demonstrated ability in leading root cause analysis & effective investigation practices.
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