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Director, mRNA Analytical Project Lead

Company: CSL Plasma
Location: Holly Springs
Posted on: January 15, 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 vaccinesLeads own team and collaborates with partner functions (i.e. Research, Process Development, Drug Product Development, QC, Clinical, Regulatory) to deliver project milestonesProvides technical subject matter expertise and leads teams develop phase-appropriate assays for release and characterize products for various clinical phasesAuthor key technical documents and CMC sections of regulatory license documents (i.e. IND, BLA)Proactively identifies innovation opportunities for mRNA platformProactively identifies project gaps and method improvement opportunitiesProactively identifies innovation opportunities in new technologies and assaysRepresent 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 improvementsDevelops multifunction team strategy and structure, recruits' personnel, and builds capability to meet mRNA analytical development goalsMaintains a state of compliance for team and self through regular review of training and implementing training curricula improvementsProvides ongoing performance feedback, technical guidance and mentorship to mRNA analytical development teamProvides 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 programUtilizes knowledge and experience of Analytical Development to provide technical support for production and testing of drug substance and drug product in GMP production and testingUses scientific and statistical knowledge to support product, process and testing related investigations and deviations including complaint, deviation, OOE and OOS investigations that require support TDProduce 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 degreeBroad 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 projectsExperience with mRNA vaccines highly desirableExperience in production of GLP/Tox test articles in compliance with quality and industry guidance expectationsExtensive 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 agilityProven track record of demonstrating collaboration and influencing skills across the organisation at all levelsExcellent communication and interpersonal skills to ensure positive working relationships are developed and maintained with internal and external stakeholders, and bodiesAbility to lead, drive and motivate people to achieve goalsAbility to support and foster a diverse and multicultural groupDemonstrated ability to present complex technical topics to a wide range of audiences with varying technical depthDemonstrated 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 managementRole model and promote CSL/Seqirus valuesDemonstrated 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 benefits 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 Seqirus.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 Diversity, Equity & Inclusion at Seqirus.Do work that matters at Seqirus!

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

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