Director, mRNA Analytical Project Lead

Company: CSL Plasma
Location: Holly Springs
Posted on: January 13, 2022

Job Description:

Job DescriptionJob SummaryThe prospective mRNA Analytical Development Lead (APL) provides leadership and scientific expertise for the strategic design, planning, and coordination of mRNA analytical development projects. He/She will Lead analytical development activities from early phase to late phase and is responsible for control strategy, raw material analytics, outsourcing testing, and analytical chemistry for mRNA program. He/She will lead a team of scientists and managers to plan and execute analytical deliverables for mRNA-based influenza vaccines. The APL will be a key contributor to define and drive CMC strategy, interface and work collaboratively with Research, Process, QA, QC, Clinical and Regulatory functionsMajor ResponsibilitiesAnalytical Development:

• Utilizes technical expertise in analytical development to define analytical strategy for development of platform-based analytics, process, and product of mRNA vaccines
• Leads own team and collaborates with partner functions (i.e. Research, Process Development, Drug Product Development, QC, Clinical, Regulatory) to deliver project milestones
• Provides technical subject matter expertise and leads teams develop phase-appropriate assays for release and characterize products for various clinical phases
• Author key technical documents and CMC sections of regulatory license documents (i.e. IND, BLA)
• Proactively identifies innovation opportunities for mRNA platform
• Proactively identifies project gaps and method improvement opportunities
• Proactively identifies innovation opportunities in new technologies and assays
• Represent Analytical Development on cross functional team(s) to provide insight and updatePeople Management:
  • Drives culture of safety, ensures team adheres to requirements, and identifies and implements improvements
  • Develops multifunction team strategy and structure, recruits' personnel, and builds capability to meet mRNA analytical development goals
  • Maintains a state of compliance for team and self through regular review of training and implementing training curricula improvements
  • Provides ongoing performance feedback, technical guidance and mentorship to mRNA analytical development team
  • Provides project and program level leadership within TD and in cross functional project teamsOperations/Quality Support:
    • Serves as interface between TD, Research and Quality, and represents TD analytical development in cross-functional forums to support mRNA program
    • Utilizes knowledge and experience of Analytical Development to provide technical support for production and testing of drug substance and drug product in GMP production and testing
    • 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 TD
    • Produce high quality technical presentations for internal audiences including senior management to update on project/program technical progressMinimum Requirements:
      • PhD or MS in related scientific field; 12+ years relevant experience with PhD; 15+ years relevant experience with MS degree
      • Broad technical expertise and experience in analytical development in vaccines (Early phase and Late phase development)
      • Project leadership experience required. Uses broad and comprehensive technical, scientific knowledge and experience to manage the outcomes and actions of a variety of complex projects
      • Experience with mRNA vaccines highly desirable
      • Experience in production of GLP/Tox test articles in compliance with quality and industry guidance expectations
      • Extensive 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, etc.
      • Demonstrated Lominger competencies in ethics and values, integrity and trust, building effective teams, command skills, developing direct reports and others, drive for results and strategic agility
      • Proven track record of demonstrating collaboration and influencing skills across the organisation at all levels
      • Excellent communication and interpersonal skills to ensure positive working relationships are developed and maintained with internal and external stakeholders, and bodies
      • Ability to lead, drive and motivate people to achieve goals
      • Ability to support and foster a diverse and multicultural group
      • Demonstrated ability to present complex technical topics to a wide range of audiences with varying technical depth
      • Demonstrated ability to deliver technical aspects of analytical development project in a cross functional working environment which includes R&D functions (Research, Reg CMC, R&D QA, Clinical, etc.) and Operations functions (QA, AS&T, QC, MS&T, etc.)
      • Flexible and adaptable attitude with the ability to support change management
      • Role model and promote CSL/Seqirus values
      • Demonstrated experience establishing and building a high performing team and managing stakeholdersAbout UsOur BenefitsSeqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the you can participate in when you join Seqirus.About SeqirusSeqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about .We want Seqirus to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about at Seqirus.Do work that matters at Seqirus!

Keywords: CSL Plasma, Cary , Director, mRNA Analytical Project Lead, Executive , Holly Springs, North Carolina