|Location:||, Wake County|
|Job Type:||Full Time|
With operations in 35+ nations and ~ 22,000 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 the second largest influenza vaccine company 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!
Reporting to the Global Head of Analytical Science and Technology at Seqirus the role provides technical support in continuous improvement for the Global Quality Control organisation across each of the manufacturing sites.
This role is responsible to provide subject matter expertise in Microbiology for variability reduction activities in test methodology through the standardization, and harmonization of method execution/standard work. This individual will support alignment of method validation lifecycle management and execute the strategy for method replacement/refinement related to Microbiology. In addition, this role will support regulatory agency and ERL communications relating to Microbiology.
This individual will support the delivery of efficiency across the entire QC network through microbiological method standardization and implementation of new QC Microbiology testing technologies. The role provides technical support and expertise related to Microbiology to the Global QC function. The scope of this role is global in nature and this individual will support AST and QC resources at each site.
- Support the alignment of the Global QC test modernisation/replacement strategy in conjunction with TD with regards to Microbiology, where applicable. Support the collaboration between AST and TD to deliver against the strategic plan to attain industry leadership in laboratory operations.
- Support the delivery of the Global QC tech transfer plan aligned to business requirements to ensure optimization of QC operations and sustain compliance status of QC testing relating to Microbiology
- Support the implementation and sustainability of a global method variability reduction program through invalid trending, control trending and method standardization to maximize the reliability of QC Microbiology data used by our manufacturing teams.
- Support implementation and sustainability of a fit for purpose method validation lifecycle for all QC sites at Seqirus to maintain compliance with regulatory body requirements and expectations.
- Global QC pharmacopeia reviews, regulatory surveillance and specification management, to ensure compliant consistent QC testing.
- Research, implement and train associates on new Microbiological technologies designed to reduce testing variability and improve reliability of results.
- Bachelor’s in life sciences field (Biology, Microbiology, Chemistry, etc.); Masters preferred.
- Minimum of 7+ years required, 10+ years’ experience in a pharmaceutical or biopharmaceutical company strongly preferred
- Experience working in a highly regulated GMP environment as it applies to laboratory functions
- Experience in preparing and complying with required regulatory guidelines including inspection readiness and follow-up.
- Experience with QC testing methods and processes
- Experience with assay methodologies and validation techniques.
- Experience with implementing root cause analysis and effective investigation practices.
- LEAN experience, preferred