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!
Scientist, Bioanalytics & Gene Therapy
Summary of Role:
- To develop analytical methods for release testing and characterization of gene therapy lentiviral vectors and cellular products as well as patient sample analysis.
- To provide analytical support for research and product development activities including preclinical studies, process development, and pharm/tox studies.
- To manage multiple workflows concurrently to meet timelines for (pre)clinical trial study reports.
- To transfer assays internally and externally where required.
- To maintain laboratory quality systems and records of analytical results.
- Position reports to Senior Manager, Bioanalytics
- The person holding this position should be capable of assisting in the supervision and training of a CF Level 4 Associate Scientist.
- Develop molecular and cellular assays to characterize lentiviral vectors and vector-transduced cells.
- Drafting of analytical test procedures, Standard Operating Procedures, and data collection forms.
- Performing cellular and molecular assays. Analytical methods include DNA-, RNA-, cell- and CFU- based assays as well as flow cytometry.
- Collating, presenting and analyzing experimental data, including statistical analysis.
- Working independently and as part of a team, perform experimental work and report results.
- Documenting assay results and reporting to Department head or to other Product Development functions, as required
- Perform Technical Transfer of methods in and out of department.
- Present experimental data at departmental or project meetings.
- Initiating change controls for documents or procedures, closing out change controls by training of staff.
- Representing the department on the R&D Safety Committee, or similar representative role
- Performing routine maintenance on scientific instrumentation, as required. Liaising with instrument engineers for repair and maintenance of equipment
- Ensuring critical instruments are calibrated and calibration records maintained.
- Ensure that high safety standards are taken into account and adhered to as governed by local, state and federal regulations, laws and policies as well as CSL’s policies and directives
Key Relationships (both internal and external)
- Departmental Heads
- Team leaders
- Research & Development Scientists
- Quality Assurance advisors
- Support staff (central services, validation, engineering etc)
- Vendor / Suppliers
- Work will be performed in the Pasadena Laboratory Facility. The position involves both laboratory and office duties.
- Excellent interaction with other R&D and Quality.
- Working hours, some off-hours work when necessary.
- A Ph.D. in molecular biology, immunology, microbiology, or a related field
- At least five years biomedical laboratory experience, preferably within a GXP setting supporting Phase I/2 clinical trials
- Experience in assay development, phase-appropriate assay validation, and execution of laboratory SOPs.
- Authorization to work in the United States indefinitely without restriction or sponsorship
Essential Skills, Knowledge & Attributes:
- Strong background in lentiviral vector gene therapy with hands-on experience in characterizing lentiviral vectors and gene-modified cell products. Experience in assessing vector potency with DNA- and RNA- based methods is highly desired.
- Competence in designing assays and formulating strategies for workup and qualification.
- Well-versed in DNA and RNA isolation and characterization (qPCR, ddPCR, multiplex PCR), and recombinant DNA methods. Quantitation of small RNAs including short hairpin RNAs is a plus.
- Well-versed in cell culture, HSPC culture, cell enrichment, isolation and culture of human MNCs from peripheral blood and bone marrow.
- Experience in multicolor flow cytometry and immunophenotyping.
- Well organized, able to plan work appropriately. Attention to detail. Mechanical aptitude and problem-solving skills.
- Ability to work effectively in a team
- Competence in assay validation, QC/QA, data analysis and reporting.
- Understanding of GLP/GMP regulatory requirements in pharmaceutical drug development.
- Experience working in a Biosafety Level 2 environment.
- Good working knowledge of Word Processing, Spreadsheets, and general PC familiarity and usage.
- Outstanding verbal and written communication skills in English.
- Scientific report writing and presentation skills.
- Mechanical aptitude and problem-solving skills.
As per Lominger competency model;
- Functional/Technical Skills
- Technical Learning
- Problem Solving
- Priority Setting
- Time Management
- Process Management
- Action Oriented
- Drive for Results
- Presentation Skills
- Written Communications
- Interpersonal Savvy
- Supervisor Relationships
- Customer Focus
- Peer Relationships
- Integrity and Trust
- Personal Learning