Chief Technology officer ( Drug Development. OSD. Generics )

Reporting directly to CEO, The Chief Technology Officer (CTO) will lead the company’s

Product Development strategy across R\&D, QA, QC, and Regulatory Affairs

, enabling efficient product development and compliant lifecycle management.

The CTO will operate as both a

strategic leader and hands-on executor. Small cell molecule and OSD experience needed. Generic / Biosimilar / experience would be a distinct advantage.

This person will also need good people / team management experience and be able to commit to being based onsite 4 days a week.

R\&D Technology \& Scientific Enablement

• Define and execute the company’s

R\&D and technology strategy

aligned with corporate objectives.

• Lead discovery and development of

new pharmaceutical products

, from early research through preclinical and early clinical development.

• Oversee portfolio planning, program prioritization, and scientific risk management.
• Monitor scientific and technological trends to maintain competitive advantage.
• Establish efficient, scalable development processes
• Ensure robust data generation, documentation, and knowledge management.

QA, QS \& QC

• Hold executive responsibility for

Quality Assurance (QA)

and

Quality Control (QC)

activities.

• Establish, maintain, and continuously improve the

Pharmaceutical Quality System (PQS)

in compliance with GxP requirements.

Regulatory Affairs

• Define and lead the

regulatory strategy

for R\&D, CDMO \& CMO programs in collaboration with internal teams and external stakeholders.

• Oversee preparation, review, and submission of regulatory documents (e.g. IND/CTA-enabling documentation).

Leadership \& Culture

• Lead scientific and technical due diligence for in-licensing, collaborations, and partnerships.
• Oversee and manage external CROs, CMOs, laboratories, and regulatory consultants.

Education \& Experience

• MSc (or equivalent preferable) in Pharmaceutical Sciences, Chemistry, Biotechnology, or a related discipline.
• 10\+ years of experience in pharmaceutical or biotech R\&D with significant leadership responsibility.

Technical \& Regulatory Expertise

• Strong knowledge of drug discovery, preclinical development, and pharmaceutical development.
• Solid understanding of GxP, quality systems, QC operations, and regulatory requirements.

Desired Skills \& Competencies

• Ability to align scientific innovation with quality and regulatory compliance.
• Strong cross-functional leadership and stakeholder management.

Reporting into the CEO this is a great opportunity to help lead the next stage of this companies development.

This role entails 4 days a week based onsite in Waterford and my client want to find someone who wants to commit to a long term project to build something great.