TSA Manager
A Technical & Scientific Affairs (TSA) Manager is required to join a biologics manufacturing company in Sligo.
As a key member of the Site Leadership Team, you will lead the technical agenda, overseeing Technology Transfer, Process Validation, Cleaning Validation, Manufacturing Operations, and R&D activities where needed.
Key Responsibilities:
* Lead and develop the TSA team, ensuring technical excellence in process investigations, root cause analysis, CAPAs, process improvements, and change controls.
* Drive new production methods, including Technology Transfer, process validation, and team training.
* Champion a continuous improvement culture, fostering innovation and problem-solving across operations.
* Work closely with National Authorities on regulatory matters, including the importation of animal-origin or pathogen materials.
* Contribute to the company's strategic direction as a key member of the leadership team and engage in professional forums.
* Build strong cross-functional partnerships across business units and collaborate with TSA teams in other locations to share knowledge and best practices.
* Support regulatory audits and ensure compliance with all Safety, Health, and Welfare legislation and company policies.
Requirements:
* Masters degree in a technical discipline (e.g., biochemistry, chemistry, biotechnology, biopharmaceuticals).
* 10+ years in the biotech/pharmaceutical industry, with hands-on experience in new product introductions and ongoing product support.
* 5+ years of leadership experience, managing direct or matrix teams.
* Strong technical expertise in pharmaceutical manufacturing processes & equipment, particularly in oral solid dose, parenterals, and/or biologicals.
* Experience in vaccines and product development is a plus.
* Proven ability to balance short-term and long-term priorities in a dynamic business environment.
* A track record of coaching and mentoring technical teams to success.