Technical Services Lead EU – Dublin, Ireland – 12 Month Contract
Nicholas Howard are delighted to be recruiting for a new and exciting role as a Technical Services Lead EU.
Based in Dublin, the successful candidate will:
- Lead, manage and coordinate technical support activities for Biologics Drug Substance and / or Drug Product at registration and post-registration stages of the product lifecycle, including but not limited to troubleshooting, process improvement, cost reduction, capacity expansion, tech transfer and validation.
- The position works closely with colleagues in Pharmaceutical Sciences, Supply Chain Operations, Quality Assurance and CMC-regulatory Affairs, while serving as a key point of technical contact between the company and multiple contract manufacturing organisations.
- The position serves as a key knowledge link between Global Manufacturing Sciences and External Biologics Operations, providing technical leadership in support of quality systems governing GMP manufacturing (e.g., deviations, investigations, CAPA and change control), regulatory submissions, and facility inspections. In addition, the position will oversee technical review / approval for manufacturing related documents such as Change Notifications, APQR and MBR.
- The incumbent must build and maintain strong relationships with key internal and external partner organizations and will be expected to develop and deliver shared objectives with key partner groups.
- The incumbent is accountable for delivering on key performance indicators, including but not limited to:
- Documentation cycle time (Technical Protocols and Reports, Regulatory Filing Support Documentations, etc),
- Right first time,
- Cost of goods and CMO productivity improvement
- Work with the Global Manufacturing Sciences network to create or enhance technical capabilities to deliver the needed capacity, quality and quantity of products required by our patients. Partner with CMO’s to ensure quality in product manufacturing.
- Define the capability we need to deliver our services and the actions we need to take to maintain and continuously improve capabilities.
- Identify and manage process improvement activities for existing commercial manufacturing operations.
- The incumbent will highlight the appropriate resources needed to quickly resolve technical issues (quality, capacity, and cost) and drive process reliability and improvements.
- The incumbent is expected to effectively support strategic corporate initiatives.
- Provide department-wide operations support for system / process improvement, evaluation of new technologies and CROs / CMOs, budget management, and resource prioritisation.
Education, Competencies and Skills:
- Requires a degree in technical / scientific education with 5 years technical industry experience in development and / or manufacturing preferred.
- Experience managing technical capabilities in a global capacity.
- Experience in managing medium to high complexity technical projects within a cross-functional matrixed organization.
- Broad knowledge and experience within the GMP environment, and regulatory affairs.
- Successful track record of change management projects and processes.
- Travel required approximately 25% – national and international.
To be considered for this position please apply below.