Process Scientist I/II (Continuous Process Verification)

About CSL

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!

Job Description

The incumbent will be a member of the Manufacturing Sciences & Technology team at the Holly Springs Influenza Vaccine manufacturing facility, supporting Bulk, Formulation, and Fill-Finish Operations. The MS&T function provides strategic technical direction to manufacturing organizations to achieve supply targets and maximize capacity. Job Purpose: The individual will utilize scientific expertise to lead statistical approaches to perform continued process verification (CPV) for commercial manufacturing support, process optimization initiatives and investigations of manufacturing deviations within MS&T. Provides statistical expertise to drive the application of statistical principles to product/process comparability, stability analysis and CPV, establishing DoE as a standard way of working where appropriate. The individual is capable of driving elements of these activities as required, including improvement and alignment of best practices with cross-functional counter parts at other sites. Major Accountabilities:
• Evaluates and implements modelling and simulation techniques.
• Evaluates statistical concepts in product optimization and manufacturing projects
• Leads the analysis of data sets to evaluate the outcome of technical studies.
• Sets manufacturing formulation targets and assess trends.
• Authors technical protocols and reports as required where statistical input is key.
• Develops key performance indicators for the CPV program.
• Continuously updates commercial production performance to support product yield.
• Monitors quality improvement plans during seasonal flu vaccine production.
• Supports the development of process troubleshooting and monitoring trending systems.
• Systems will be used for the continued process verification (CPV) plan.
• Authors periodic CPV reports for analysis pf process technology innovations.
• Manages updates to alert and alarm limits for parameters.
• Manages and maintains process monitoring tools (connected to OSI Pi, LIMS, SAP, etc.)
• Uses a structured statistical approach to guide MS&T team.
• Utilizes statistical knowledge and experience when authoring.
• Provides technical content for regulatory submissions interacting with health authorities.

• Bachelor's degree is required.
• Degree in an engineering, science, or statistics discipline is preferred.
• Minimum 2+ years of experience with a Bachelors degree, 0+ years (MS) related industry experience preferred.
• Knowledge of Excel, OSIsoft PI, Minitab, JMP, and R systems preferred.
• Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) and working in clean room environments preferred.