Scientific Associate I (Separations)
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 Associate Scientist hired for this position will support development and testing of analytical separation methods for large molecules including nucleic acid and protein. The scope will include support of process and product development activities as well as the execution of developmental stability studies.Major Responsibilities:
- Execute separations assays such as HPLC, UPLC, and CE to support process and product development.
- Data collection and reporting with knowledge of GLP/GMP environments.
- Work closely with the Molecular/Cellular Biology, Biochemistry, MS groups within TD-Analytical
- Perform tasks under limited supervision.
- Provide support on reviewing documentation in notebooks and reviewing data in LIMS for specific lab-based processes that the employee is trained on.
- Able to work under tight deadlines.
- Ensure all experimental procedures and documentation are compliant with highest quality and regulatory standards.
- Partner with diverse team members from various functions, countries and members at various levels in the organization.
- Functions effectively as core team member.
- Interface with electronic business systems (e.g, LIMS, SAP, EDMS)
- 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 analytical techniques used in biopharmaceutical (i.e., vaccines) process development and GMP manufacturing
- Uses scientific and statistical knowledge to support product, process and testing related investigations and deviations including complaint, deviation, OOE and OOS investigations that require support for development work
- Generates a supportive business case, and supports cross-functional teams to deliver those opportunities
- Completes individual training and maintains a state of compliance
- Adheres to all safety requirements
- Supports communication/updates as required
- Bachelor’s Degree in related scientific field
- 0-2+ years of related experience with hands on experience in analytical separations techniques using Empower software is required.
- Requires conceptual and practical knowledge in separation techniques (HPLC, UPLC, CE)
- Experience with Empower is highly desired
- Previous experience in working with RNA is highly desired
- Experience in biopharmaceutical analytics is desirable
- Effective delivery of objectives in a complex matrix environment
- Ability to deal with rapid change
- Effective verbal & written communication skills in a cross functional environment
- Attention to detail