Excellent Senior role for a Head of Pharmaceutical Development - Respiratory R&D, in a leading pharmaceutical company based in Waterford City.
Reporting to the Vice President, Respiratory Product Development
The Role outline is as follows:-
The role is of strategic importance to maintain the Company's strength in combination product development, to help deliver on the Respiratory long range plan and develop standing within the Global R&D CMC organisation.
The Company's Respiratory R&D are seeking a highly innovative and self-motivated individual with strength in pharmaceutical product development and strong leadership skills to help drive development of combination products within the Company's Respiratory's portfolio.
Broad, hands on experience in development of a product from first principles through to product registration and beyond is essential. The individual will lead a multi-disciplinary technical team, liaise with other functional disciplines within the pharmaceutical product development organization and collaborate extensively with external organizations.
The ideal individual will have specialised skills and experience gained from working at the forefront of respiratory product development. They will probably already be an experienced functional or project manager with a strong appreciation of the technical and regulatory challenges associated with developing robust products for global markets.
Responsibilities
- A strong leader/manager, providing direction and guidance to scientists and technicians to develop robust combination drug products within the company's global R&D portfolio. In your primary role representing Waterford R&D, you will manage the assigned CMC project portfolio, working with global project teams to ensure successful delivery of project milestones to time and cost.
- Provide enlightened strategic input to influence the direction and approach to development; recommend new technologies for investment and help enhance product differentiation.
- Ensure high levels of engagement and enablement amongst staff. Look for new opportunities to improve effectiveness.
- Work cross functionally across complex, multi-disciplinary organizations. As necessary, develop external vendor and academic network
- Manage manufacture of investigational medicinal products in accordance with site cGMP licence.
- Ensure technologies are developed and validated to appropriate scale and transferred into manufacturing operations.
- Effective and timely written and verbal communication.
- Compilation of Module 3 regulatory submissions and associated correspondence with regulatory agencies.
- Participate in QA/Technical audits of third party contractors. Help establish appropriate procedures and practices to drive continuous improvements to ensure all activities are performed in accordance with regulatory, quality and contractual standards.
Education / Experience
- Preferably a Doctorate or Masters qualification in chemistry (or related subject) and at least 10 years' industry experience in pharmaceutical product development. Hands on experience of leading a project within the respiratory field would be an advantage.
- In depth understanding of the unique challenges associated with the development of combination drug products.
- Ability to conceptualize ideas, motivate and focus individuals.
- Must have a track record of leading multifunctional teams and multidisciplinary development projects.
- Proven project management, planning and influencing skills.
- Focused on delivery / capable of taking the initiative.
- In depth knowledge of global regulatory and compliance requirements.
- In depth knowledge of the IP and competitive landscape of device and drug delivery technologies.
- Experience of working to current Good Manufacturing Practice and/or Good Laboratory Practice and implementing policies and procedures in line with regulatory guidelines.
- Very strong verbal and written communication; collaboration and team building skills; ability to connect with all levels of the organisation.
