Senior Scientist

The Opportunity: As a Senior Scientist for Cell-based and Potency Assay Development at CSL Seqirus in Holly Springs, NC, this important role within the sa-mRNA Analytical Development team involves leading the creation and refinement of cell-based and molecular biology assays, specifically focusing on the development of sa-mRNA-based potency assays. In addition to advancing process and product understanding through these assays, you will play an important role in the compliant manufacturing and release of sa-mRNA vaccines. The scope of work includes the optimization, transfer, qualification and validation of assays. The successful candidate will be a detail-oriented and self-driven leader, can multitask in a dynamic environment, and able to foster collaboration across several departments to enhance analytical development in the biopharmaceutical industry. Moreover, we ask that you have previous experience managing a team of scientists, ensuring that the leadership will contribute to the development of materials for clinical trials in close collaboration with the Process Development, Regulatory, Manufacturing, Quality Control and Quality Assurance departments.  The Role:

• Execute strategies for the creation, qualification, and transfer of bioassays and potency assays, contributing to the support of pre-clinical and early/late-stage clinical programs, and product release activities.
• Develop new methods, including in vitro cell-based potency assays and molecular biology assays to support both product release and in-process testing.
• Draft a variety of technical documents, such as standard operating procedures (SOP) for methods, development reports, qualification protocols and corresponding reports, comparability plans and reports, as well as Quality by Design (QBD) risk assessments that are compliant with cGMP standards.
• Responsible for supervising and managing a team of 2-4 scientists.
• Provide data and technical documents to support regulatory filings such as IND, Module 3 updates and BLA submissions.
• Responsible for evaluating Critical Quality Attributes (CQA), assessing risks, and analyzing gaps to enhance the robustness of bioassays, in addition to developing strategies for bioassay reference controls.
• Maintain rapid turnaround times while prioritizing work according to the company and program needs to make sure timelines are met.
• Prepare and deliver presentations on experiments and data to colleagues and management in diverse areas such as Process Development, Regulatory, Manufacturing, Quality Control and Quality Assurance. 
• Support upstream and downstream process optimization by generating analytical test results regarding the quality attributes of in-process materials and drug substances.
• Troubleshoot instrumentation and analytical testing methods. Support laboratory operations including instrument maintenance and supplies management.
• Ensure all experimental procedures and documentation are compliant with the highest quality and regulatory standards.
• Document experimental data, results, and conclusions in an electronic laboratory notebook.
• Routinely present work in internal meetings.

Skills & Experience:

• PhD /MS in Biochemistry, Molecular Biology, Analytical Chemistry, Virology, or a related field.
• MS + 10 or PhD + 5 years of direct experience in analytical development within the biopharmaceutical industry, including 2 or more years in leadership roles.
• Prior experience with sa-mRNA-based vaccines and mammalian cell-based culture assays will be considered a plus.
• Previous experience supervising a team of 2-4 scientists is required. 
• Hands-on experience and working knowledge across cell-based and molecular biology assays such as qPCR/ddPCR, ELISA, flow cytometry, spectrophotometry, BLI, SPR, and gels. 
• Experience developing cell-based or potency assays and establishing assay strategies up to clinical phase I is necessary, while experience extending through phases II and III is advantageous.
• Familiarization with ICH, EMA and FDA guidelines is expected. Experience in qualifying and transferring analytical test methods.
• Proficiency in engaging with and addressing inquiries from regulatory agencies is necessary . 
• Ability to troubleshoot instrumentation and analytical test methods.
• Must have scientific documentation skills to help write electronic notebook entries, protocols and technical reports for internal documents and regulatory filings.
• You should be a detail-oriented person who can effectively communicate results and conclusions to your colleagues and management.
• Ability to multitask among multiple projects in a fast-paced environment.
• You should be a collaborative team member that can effectively partner with colleagues across a matrix organization, including diverse functions such as Process Development, Regulatory, Manufacturing, Quality Control and Quality Assurance. 
• Excellent written and verbal communication skills .

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL

CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL .

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