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Scientist I/II (Molecular Analytics)

Company: CSL Behring
Location: Holly Springs
Posted on: May 14, 2022

Job Description:

Job DescriptionJob SummaryThe prospective scientist will be responsible for the design, execution, and qualification of analytical method development activities utilizing Cell and Molecular Biology techniques. This work will support analyses of APIs, DP, process impurities and stability by-products across multiple platforms. The individual will provide scientific expertise for process and product development projects through TD into Operations. Supports projects that will drive future growth through process improvements and uses scientific knowledge to ensure studies are well designed, executed, documented and have clear, measurable benefits. Leads and drives elements of these activities as required.Major ResponsibilitiesDevelopment Work

  • Contribute to the development and qualification of Molecular Biology analytical assays to support process and product development, including characterization and quantitation analyses of both in-process samples and final products
  • Evaluate novel Molecular Biology analytical technologies, propose new assays or improvements to current methods
  • Work closely with the Separation, Biochemistry and Mass Spec groups within TD-Analytical, as well as provide technical expertise in support of analytical methods being executed within the process development groups
  • Author study protocols, characterization reports, and/or scientific manuscripts for external publication
  • Use a data driven approach to progress development deliverables
  • Present results at internal and external meetings
  • Ensure all experimental procedures and documentation are compliant with highest quality and regulatory standards
  • Support the development and execution of strategies, plans, processes and methods to enable product and process development, and method and process transfers and improvements for TD
  • Proactively identify development and improvement opportunities
  • Functions effectively as core team member on multiple concurrent projects and leads small projects and establishes work processesOperations/Quality Support
    • Serves as interface between TD and Operations, and represents TD department in cross-functional forums to support manufacturing and QC
    • Utilizes knowledge and experience with analytical techniques used in biopharmaceutical (i.e., vaccines) process development and GMP manufacturing
    • 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 for development work
    • Generates a supportive business case, and supports cross-functional teams to deliver those opportunitiesPeople Management
      • Provides guidance to new team members, interns and students and acts as a resource for colleagues with less experienceMinimum Requirements
        • Master's Degree or PhD in related scientific field
        • 5-8 years with MS or 2-4 years with PhD
        • Requires in-depth conceptual and practical expertise in the development of Molecular Biology assays for biologics or vaccine molecules
        • Extensive experience in working with DNA and RNA required
        • Experience in qPCR, RT-PCR and digital PCR required
        • Provides technical advice on issues within own discipline
        • Effective delivery of objectives in a complex matrix environment
        • Ability to deal with rapid change
        • Effective verbal & written communication skills in a cross functional environment
        • Attention to detail
        • Proactively owns and drives assigned tasks to completion
        • Ability to present solutions to complex and strategic issues
        • Evidence of commercial awareness in technical strategies
        • Excellent customer focus with demonstrated management of customer expectations
        • Effective presentation skillsPreferred Attributes
          • Experience in next-generation sequencing (NGS) technologies is advantageous
          • Experience in biopharmaceutical analytical development and method qualification is desirableAbout 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 Behring, Cary , Scientist I/II (Molecular Analytics), Other , Holly Springs, North Carolina

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