role as an External Technical Services EU Manager.
Role Description:
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
M .
Required Skills / Qualifications:
* Minimum of 5yrs experience plus a Life Sciences degree preferred.
To be considered for this position please apply below Nicholas Howard are delighted to be recruiting for a new and exciting
role as an External Technical Services EU Manager.
Role Description:
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
M .
Required Skills / Qualifications:
* Minimum of 5yrs experience plus a Life Sciences degree preferred.
To be considered for this position please apply below
We need : English (Good)
Type: Permanent
Payment:
Category: Others
