Associate Director, mRNA Analytical Development

Responsibilities

As the Associate Director, you will provide project leadership and scientific expertise for the strategic design, planning, and coordination of mRNA analytical development activities. Reporting to the Sr. Director, you will manage mRNA assay development, qualification, transfer, and analytical activities related to clinical trial material in Holly Springs. You will lead analytical development activities from early phase to late phase for mRNA pandemic program. Your knowledge will provide scientific expertise to ensure studies are well thought out and have clear, measurable benefits.

The Role

Analytical Development

You will:

• Collaborate with R&D senior staff to create technical strategy for development of platform-based analytics, process, and product.
• Lead analytical development for necessary sa-mRNA projects
• Provide technical subject matter expertise in the analytical development space
• Lead analytical development execution from early development stage to late-phase, and lead analytical development activities and deliverables
• document deliverables for the sa-mRNA program
• Author important technical documentation and ensure required document deliverables for the sa-mRNA program, including regulatory filing
• Identify project gaps and method improvement opportunities as well as, innovation opportunities in new technologies and assays
• Represent Analytical Development to provide insight and update

People Management

You will:

• Promote a culture of safety, ensure team follows requirements, and implement improvements
• Maintain a state of compliance for team and self through regular review of training and implementing training curricula improvements
• Provide ongoing performance feedback, technical guidance and mentorship to analytical development team
• Provide program level leadership within TD and in project teams

Operations/Quality Support

You will:

• Be the interface between TD, Research and Quality, and represent TD analytical development in forums to support mRNA program
• Use experience of Analytical Development to provide technical support for production and testing of drug substance and drug product in GMP production and testing
• Use scientific and statistical knowledge to support product, process and testing related investigations and deviations including complaint, deviation, OOE and OOS investigations that require support TD
• Present complex technical topics to multiple audiences with varying technical depth
• Deliver technical aspects of analytical development project in a working environment which includes R&D functions (Research, Reg CMC, R&D QA, Clinical, etc.) and areas within Operations (QA, AS&T, QC, MS&T, etc.)
• Experience writing content for technical documentation including product and process development plan, analytical control strategy, analytical target profile, JOS, comparability protocol and reports, regulatory CMC license sections and presentations.

Qualifications:

• M.S. or PhD.; 12+ years with Master Science or 8+ years with Ph.D. in related scientific field. B.S. degree with equivalent experience.
• Broad technical expertise in analytical development in vaccines (Early phase and late phase development)
• Demonstrated experience establishing and building a team and managing partner
• Project leadership experience required.
• Experience with mRNA vaccines desirable

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

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