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Posted Friday, July 14, 2023
Posting ID: JP-003907009
assessment of new molecule purification process development
reviewing and compiling relevant literature data to include structure, physio-chemical, and biological
data on the target viral vector (when available), to propose the most suitable purification process train of
steps based on these data.
Develop and demonstrate a robust, high purity/yield, economic and scalable purification process for clinical stage Viral Vectors, with particular attention to regulatory expectations on product quality and availability and suitability of raw materials, reagents, and separation materials and equipment.
Operate and troubleshoot bench top and pilot scale Ultrafiltration/diafiltration procedures, particularly in using tangential flow filtration (TFF) for viral harvesting.
Pack, operate, and troubleshoot bench top and pilot scale Chromatography Columns; compile and analyze results
Perform and analyze Design of Experiment (DOE) studies to develop or optimizing processes to ensure a phase-appropriate, consistent, high-yielding, high-purity, and scalable downstream purification.
Generate, manage, evaluate, and maintain critical data in a highly organized manner. Provide reports for assessment by management.
Assist in scale up and optimization of early-stage processes, support critical operations as needed in our GMP manufacturing facility and deliver materials for pre-clinical and clinical studies.
Provide reagents and other supplies for various projects and departments.
process characterization studies and tech transfer processes. As needed, support process validation, including validation protocol writing, execution and report writing.
Responsible for integrating robust viral clearance steps into the process and working closely with the Viral Clearance Validation team, including review of protocols, execution of studies, and report writing.
Clean room, Cell Therapy, batch record review, Lead
Top Skills Details:
Clean room,Cell Therapy,batch record review,Lead
Additional Skills & Qualifications:
ph.D Degree in Biology Related Field + 3+ Years of relevant industry experience in Cell & Gene Therapy within Viral Vector
MS Degree + 5+ Years of relevant industry experience in Cell & Gene Therapy within Viral Vector
3 Years of hands-on downstream purification experience with Viral Vectors