Manager (Small Scale Filling)
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
The incumbent is accountable for leading and managing all aspects of the Small Scale Filling Facility in Holly Springs, NC. This includes accountability for the maintenance of the existing, qualified facility and future projects/products that are introduced into the area. Duties include directing and coordinating all aspects of personnel, facility, process, and equipment for the SSF area. This individual will also have responsibility for the facilities budget planning and control.
- Supervises a staff of shift production personnel to ensure safety, training and quality compliance are prioritized for manufacturing goals by focusing on the following:
- Development, training, and performance management of manufacturing staff
- Manages resources and material requirements to meet production and budget targets
- Schedules manufacturing activities as well as facilitates the completion of equipment maintenance and validation
- Utilizes Seqirus business systems (SAP, TrackWise, SuccessFactors, EDMS, Delta V, Data Historian) to execute production operations
- Initiate and Support continuous improvement initiatives, Serves as a process expert, technical resource and coach for the production team
- Supports capital projects and product transfers as required.
- Responsible for content and correct execution of SOPs and production batch records. Responsible for deviation investigations and technical problem solving. Ability to own EDMS workflows and Trackwise records, where required.
- Interface with support groups to implement and update preventative maintenance plans, coordinate creation and execution of work orders, and ensure spare part quantities are appropriate.
- Builds and maintains the area production and project schedules and ensures on time delivery against the required deliverables.
- Prepares the facility budget and monitors and controls spend.
- Bachelor's Degree in an engineering or science discipline preferred.
- Minimum 4 years' related industry experience, although 8+ years preferred.
- Demonstrated knowledge of GMPs and FDA requirements is required.
- Knowledge and experience in formulation, filling, automated inspection, or packaging technologies is preferred.
- Experience managing a matrix team, or direct management experience is preferred.