Scientist I (Technical Development/Upstream)

About CSL

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!

Job Description

The individual provides scientific and programming expertise for development of tools used in process development projects and commercial support through Technical Development (TD) into Operations. Supports projects that will drive future growth through process improvements. Uses scientific/engineering knowledge to ensure studies are well thought out and have clear, measurable benefits. Uses programming knowledge to build and maintain tools that can lead to deeper process understanding and to identify areas of improvement. Leads and drives elements of these activities as required. MAJOR ACCOUNTABILITIES: Development Work:
• Supports technical development in maintaining and developing data management tools to enhance cross functional data review and analysis
• Supports the development and execution of strategies, plans, processes and methods to enable product and process development, and method and process transfers and improvements for TD.
• Uses a data driven approach to progress development deliverables
• Proactively identifies development and improvement opportunities, generates a supportive business case, and supports cross-functional teams to deliver those opportunities
• Functions effectively as core team member on multiple concurrent projects and leads small projects and establishes work processes
• Responsible for using scientific knowledge to support site / global projects
• Utilizes knowledge of different programming languages to build and maintain tools to meet the needs of the development team. Operations/Quality Support:
• Serves as interface between TD and Operations, and represents TD department in cross-functional forums to support manufacturing and QC
• Utilizes knowledge and experience with data mining and bio-process control to provide technical support for production of drug substance and drug product in a GMP environment.
• Uses scientific and statistical knowledge to support product, process and testing related investigations and deviations including complaint, deviation, and investigations that require support for development work. People Management:
• Provides guidance to new team members, interns and students and acts as a resource for colleagues with less experience Other:
• Completes individual training and maintains a state of compliance
• Adheres to all safety requirements
• Supports communication/updates as required

Job Summary:

The individual provides scientific and/or engineering expertise for development of cell culture processes used in process development projects and commercial support through Technical Development (TD) into Operations. Supports projects that will drive future growth through process improvements. Uses scientific/engineering knowledge to ensure studies are well thought out and have clear, measurable benefits. Uses bioreactor/bioprocessing knowledge to drive deeper process understanding and to identify areas of improvement. Leads and drives elements of these activities as required.

Major Accountabilities:

Development Work:

• Responsible for definition and characterization of bulk production upstream processes to support product and process development for assigned vaccine programs.
• Drive innovation in establishing new upstream processes based on novel technologies and implementation of laboratory systems for rapid transition of viral vaccine candidates from R&D to Clinical.
• Supports the development and execution of processes and methods to enable product and process development transfers and improvements.
• Uses a data driven approach to progress development deliverables.
• Proactively identifies development and improvement opportunities, generates a supportive business case, and supports cross-functional teams to deliver those opportunities.
• Functions effectively as core team member on multiple concurrent projects and leads small projects and establishes work processes.
• Responsible for using scientific/engineering knowledge to support site / global projects.

Operations/Quality Support:

• Serves as interface between TD and Operations, and represents TD department in cross-functional forums to support manufacturing and QC.
• Utilizes knowledge and experience with data mining and bio-process control to provide technical support for production of drug substance and drug product in a GMP environment.
• Uses scientific and statistical knowledge to support product, process and testing related investigations and deviations including complaint, deviation, and investigations that require support for development work.

People Management:

• Provides guidance to new team members, interns and students and acts as a resource for colleagues with less experience.

Other:

• Completes individual training and maintains a state of compliance.
• Adheres to all safety requirements.
• Supports communication/updates as required.

And other job duties that may be assigned from time to time.

Minimum Requirements:

• Bachelor's, Master's Degree or PhD in related scientific or engineering field or equivalent.
• 5+ years with BS, 3+ years with MS or 0+ years with PhD.
• Experience in biopharmaceutical development in upstream cell culture related area [one or more of various disciplines (but not limited to) , Molecular Biology, Virology, Cell Culture].
• Prefer experience with computer programming languages including (R, Python, SAS JMP) , but not required.
• Experience working with bioreactors in small- or large-scale environment. (High Throughput Ambr systems preferred).
• Functions effectively as a core team member on multiple concurrent projects and leads small projects and established work processes.