Scientific Associate I (Stability / Technical Development)
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 Scientific Associate I (Stability) incumbent will provide sample support in TD lab to include the administration of in-process, stability samples, and TOX samples primarily in support of the sa-mRNA project. Additional responsibilities include a basic understanding of LIMS system, effective interactions/communication with TD management, and support of investigations. The Associate I may also contribute to Analytical testing of various protein and RNA methods for characterization of TOX or CTM material. The Scientific Associate I should be able to work effectively within the group and across the site to collaborate as needed.Major Responsibilities:
- Support sample management activities including but not limited to sample submission, sample receipt, external testing
- Perform Analytical assay execution in support of vaccine process and product development programs, e.g. Ribogreen, gel electrophoresis, ELISA etc. as required
- Assist in stability LIMS builds and stability sample pulls, participate in sample forecasts to ensure lead time notice, and turning samples over to lab for testing
- Responsible for detailing requirements for LIMS builds and/or building and testing new LIMS builds and LIMS Master Data changes.
- Responsible for reporting issues to management and participating in issue resolution (such sample integrity issues, sample plan errors etc.)
- Responsible for contributing to and/or handle laboratory investigations for events.
- Responsible for assessing existing situations and suggesting continuous improvements to increase compliance and innovation.
- Data collection and reporting with knowledge of GLP/GMP environments.
- Work closely with the Separation, Biochemistry, and Molecular and Cellular Biology groups within TD-Analytical
- 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.
- Preferrable to have experience with with electronic business systems (e.g, LIMS, SAP, EDMS)
- Write and revise documents such as SOPs and technical reports as required
- Serves as interface between TD and Operations, and represents TD department in cross-functional forums
- 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
- 2-4+ years of related experience with hands on experience in LIMS software preferred and hands on assay experience with electrophoresis, immunoassay and other protein analysis required
- Experience with a LIMS system is highly desired
- Experience with analysis of proteins and/or RNAs 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
- Excellent customer focus with demonstrated management of customer expectations