Job Description

The Opportunity

Reporting to a Senior Scientist, Flow Cytometry Core, Bioanalytics, your role will involve the development of analytical methods for the testing and characterization of gene therapy lentiviral vectors, cellular products, and patient samples. Your primary responsibility will be to provide analytical support for multiple research and product development activities, including preclinical studies, process development, and pharmacology/toxicology studies. You will need to manage multiple workflows simultaneously to meet timelines for (pre)clinical trial study reports. Assay transfer both internally and externally may be required, and it is important to maintain laboratory quality systems and keep accurate records of analytical results.

The Role

• Develop cellular assays to characterize lentiviral vector-transduced cells.
• Draft analytical test procedures, Standard Operating Procedures (SOP), and data collection forms.
• Perform cellular assays. Analytical methods include cell-based assays as well as flow cytometry.
• Collate and present experimental data, including statistical analysis.
• Perform experimental work and report results.
• Document assay results and report 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.
• Initiate change controls for documents or procedures, closing out change controls by training of staff.
• Represent the department on the R&D Safety Committee, or similar representative role.
• Perform routine maintenance on scientific instrumentation. Collaborate with instrument engineers for maintenance of equipment.
• Ensure important instruments are calibrated and calibration records maintained.
• Ensure that high safety standards are considered and observed as governed by local, state and federal regulations, laws and policies and CSL\xe2\x80\x99s policies and directives.

Your skills and experience

• Advanced degree required (i.e. PhD or Master\'s) in immunology, molecular biology, microbiology, or a related field.
• Minimum of 5 years of biomedical laboratory experience required, preferably within a GxP setting supporting Phase I/2 clinical trials.
• Experience developing validated multicolor phenotyping and functional flow cytometry panels and related SOPs and software; competence in assay validation, QA/QC, data analysis and data reporting
• Understanding of GLP/GMP regulatory requirements in pharmaceutical drug development and experiencing working in a Biosafety Level 2 environment.
• Background in lentiviral vector gene therapy with hands-on experience characterizing gene-modified cell products.
• Well-versed in cell culture, HSPC culture, cell enrichment, isolation and culture of human MNCs from peripheral blood and bone marrow.

The expected base salary range for this position at hiring is $100,000 - $125,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our to see what\xe2\x80\x99s available to you as a CSL employee.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about .

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about at CSL.

Do work that matters at CSL Behring!

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