The QC Analytical Technology Senior Manager, Gene Therapy is an established gene therapy analytical method subject matter expert. The Senior Manager will manage the analytical method life cycle management to support the CSL gene therapy portfolio and will take accountability for managing the development, validation and maintenance of methods used to support the manufacture and release of novel gene therapy products.
A minimum of 7 years' experience in method development for assessment of biological pharmaceutical products with at least 3 years' experience in cGMP Quality Control laboratoriesexperience in method development and validation for testing of AAV or similar products for gene therapy suitable for cGMP applicationExperience in cGMP testing, with experience in the QC testing of gene therapy products a bonusexperience in all aspects of analytical method lifecycle management and an understanding of the requirements associated with gene therapy productsexperience in practical application of concepts into cGMP environmentstechnical and experience in the testing and characterization of gene therapy products, including experience with cell-based potency methods, DNA analysis techniques (such as RT-PCR, qPCR, ddPCR, NGS), electrophoresis methods (such as SDS-PAGE, Western blotting, CE-SDS, CZE, cIEF), chromatographic methods (such as RP-HPLC, SEC, SEC-MALS), and advanced characterization techniques (such as SPR, AUC, MALDI)Demonstrated experience managing complex project deliverablesExperience working with external manufacturing and testing organizationsExperience in project management and matrix leadershipExperience coaching of more junior colleagues
As an established subject matter expert in the release and characterisation testing of gene therapy products, the Senior Manager will support the appropriate implementation of new methodologies and technologies as required and provide expertise in the evaluation and interpretation of data used to establish process and product controls. You will report to the Director of QC Analytical Techniques.
A minimum of 7 years' experience in method development for assessment of biological pharmaceutical products with at least 3 years' experience in cGMP Quality Control laboratories experience in method development and validation for testing of AAV.
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CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
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