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Scientist I/II (Technical Development) LC-MS

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

Job Description:

Job DescriptionJob Purpose:Will lead the Liquid Chromatography -Mass Spectrometry based method development for characterizing proteins, mRNAs and lipid nanoparticles (LNPs) in support of vaccine development, production, process related investigations and improvement.Responsible for assay transfer and qualification to support CTM release, in-process control, IND and BLA filing. In addition, the individual will work closely with scientists across different functions for process improvement and product formulation optimization.Mentor junior scientific associates in a matrix R&D environment.Major Accountabilities:1.-- --- --- --- --- --- --- --- --- --- - Development Work:- Designs and executes experiments for qualitative and quantitative LC-MS analysis of viral vaccine candidates and standards- Contributes to method qualification to support process and product development- Evaluates novel analytical technologies, proposes new analytical methods or improvements to current methods- Uses a data driven approach to drive development deliverables- Proactively identifies development and improvement opportunities, generates a supportive business case, and drives cross-functional teams to deliver those opportunities- Leads the development and execution of strategies, plans, and methods to enable product and process development, and method transfers- Authors study protocols, characterization reports, and/or scientific manuscripts for external publication and patent application- Ensures all experimental procedures and documentation are compliant with highest quality and regulatory standards2.-- --- --- --- --- --- --- --- --- --- - Operations/Quality Support:- Serves as a primary or secondary interface representing the group between TD and Research, Operations, and represents TD in cross-functional forums to support vaccine development, manufacturing and QC.-Utilizes extensive knowledge and experience to provide technical leadership for production and characterization of drug substance and drug product, support manufacturing and QC.-Acts as an SME authoring and providing technical content for IND and BLA.-Uses scientific and statistical knowledge to provide leadership for product, process and testing related investigations and deviations including complaint, deviation, OOE and OOS investigations that require support for development work.3.-- --- --- --- --- --- --- --- --- --- - People Management:-Provides guidance and mentorship to less experienced colleagues and team members4.-- --- --- - Other:- Completes individual training and maintains a state of compliance- Adheres to all safety requirements- Supports communication/updates as requiredMinimum Qualifications:Master's degree or Ph.D. in biochemistry, biophysics or other chemistry related scientific field required.Minimum of 3+ years of experience and a Masters degree or Ph.D.Must have extensive experience with LC-MS method development for large molecule analysis; experience with method qualification and sample testing in a GxP environment is highly desiredHighly proficient in utilizing Thermo's LC-MS systems: Vanquish Duo, TSQ, Orbitrap XL and Exploris instrumentFamiliar with MS data analysis software: TraceFinder, Chromeleon, BioPharma Finder, Skyline and Mascot Database Search EngineIn-depth knowledge on protein and/or mRNA chemistry is also a must; having background in molecular biology or cell biology is a plusAble to work on multiple projects at the same time in a fast-paced R&D environmentMust be detail oriented to minimize human errors in performing experimentsAble to independently design experiments and perform data analysis/interpretation to draw solid conclusionsProactively identify novel approaches to improve existing assays as a scientific leader in the related fieldDemonstrated leadership abilities through project managementDemonstrated Lominger competencies in ethics and values, integrity and trust, decision quality, functional/technical skills, peer relationships, perseverance and problem solvingEffective delivery of objectives in a complex matrix environmentEffective verbal & written & presentation skills in a cross functional environmentAbility to work within a matrixed team environment is essentialAbout 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 (Technical Development) LC-MS, IT / Software / Systems , Holly Springs, North Carolina

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