Nicholas Howard are delighted to be recruiting for a new and exciting role as a Graduate Level External Technical Services EU Manager.
The successful candidate will lead, manage and coordinate technical support activities for the 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 Development, Supply Chain Operations, Quality Assurance and CMC-Regulatory Affairs, while serving as a key point of technical contact between the organisation 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.
Required Skills / Qualifications:
- Minimum of 2yrs experience plus a Life Science degree preferred.
To be considered for this position please apply below.