Scientist II (Biophysical Assays)

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 Summary:

The individual will develop biophysical assays to characterize proteins, RNAs, and lipid nanoparticles (LNPs).  The incumbent will serve as a subject matter expert (SME) within the analytical department to support vaccine development, production, process related investigations and improvement. He/she will be responsible for assay transfer and qualification to support CTM release, in-process control, IND and BLA filing. In addition, the individual will work closely with other scientists and scientific associates to design and evaluate novel analytical methods to expand our current biophysical capability. He/she will mentor/supervise junior scientific associates in a matrix R&D environment.

Development Work:

• Proposes and evaluates novel analytical technologies and methods to support new products development and to increase our understanding to the existing products  
• Contributes to method development and qualification to support process and product development
• Uses a data driven approach to drive development deliverables
• Proactively identifies development and improvement opportunities, generates a supportive business case, and drives cross-functional teams to deliver those opportunities
• Leads the development and execution of strategies, plans, and methods to enable product and process development, and method transfers
• Authors study protocols, characterization reports, and/or scientific manuscripts for external publication and patent application
• Ensures all experimental procedures and documentation are compliant with highest quality and regulatory standards

Operations/Quality Support:

• Serves as a primary or secondary interface representing the group between TD and Research, Operations, and represents TD in cross-functional forums to support vaccine development, manufacturing and QC.
• Utilizes extensive knowledge and experience to provide technical leadership for production and characterization of drug substance and drug product, support manufacturing and QC.
• Acts as an SME authoring and providing technical content for IND and BLA.
• Uses scientific and statistical knowledge to provide leadership for product, process and testing related investigations and deviations including complaint, deviation, OOE and OOS investigations that require support for development work.

People Management:

• Provides guidance and mentorship to less experienced team members

Other:

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

• Master’s degree or Ph.D. in biochemistry, biophysics or other chemistry related scientific fields

• Master's degree with 8+ years of experience, or Ph.D. with 4+ years of experience

• Extensive experience in biophysical method development for characterizing proteins, RNAs and LNPs. SME for at least one of the following techniques:  Dynamic Light Scattering (DLS), Field Flow Fractionation (FFF), Multi-Angle Light Scattering (MALS)

• Experience with LC-MS method development is a plus

• Demonstrated leadership abilities through project management

• Self-motived and be proactive with minimal supervision

• Timely delivery of objectives in a dynamic environment to meet timelines and project milestones

• Effective verbal & written & presentation skills in a cross functional environment

• Ability to work effectively in a matrixed team environment is essential