The Opportunity:
We are seeking a highly motivated talent to develop analytical methods to characterize mRNA based vaccine candidates within the Technical Development.
You will provide analytical support for process development, process related investigation and clinical trial material (CTM) production within the global Biopharmaceutical Product Development.
You will be responsible for sample testing, assay qualification and assay transfer to clinical QC.
You will work closely with QA, DS, DP and CMC team to support CTM release, in-process control, IND and BLA filing.
The Role:
Proposes and evaluates novel analytical technologies and methods to support new products development and to increase our understanding to the existing products
Contributes to method development and qualification to support process and product development
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 standards
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.
Provides guidance and mentorship to less experienced team members. May have one direct report depending on the experience of the candidate.
Skills and Experience:
Master’s degree with 5+ years of experience and Ph.D. with 3+ years
Extensive experience in LC-UV-(MS) and/or biophysical method development for characterizing ScDNA, linearized DNA, mRNAs, lipids and lipid nanoparticles (LNPs).
Must be subject matter expert in applying at least two of the following techniques in industry setting: Liquid Chromatography (LC), Mass Spectrometry (MS), Capillary electrophoresis (CE), Dynamic Light Scattering (DLS), Field Flow Fractionation (FFF), Multi-Angle Light Scattering (MALS)
In-depth knowledge in mRNA chemistry is a must; background in cell biology is a plus
Must be self-motived and proactive at work with minimal supervision
Demonstrated Lominger competencies in ethics and values, integrity and trust, decision quality, functional/technical skills, peer relationships, perseverance and problem solving
Timely delivery of objectives in a dynamic environment to meet timelines and project milestones
Effective verbal & written & presentation skills in a cross functional environment
Demonstrated leadership abilities through project management
Our Benefits
CSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL Seqirus has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL Seqirus employee.
About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus.
We want CSL Seqirus to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
Do work that matters at CSL Seqirus!
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