PharmaLex
Beyond the science | using technology-enabled services to accelerate decision making and drive efficiency gains
Regulatory Affairs • Pharmacovigilance • Regulatory Operations • Pharmaceutical Quality • Audit / Inspection Preparation
1001 - 5000
Softmax Pro Developer
August 27
🏡 Remote – Anywhere in California
PharmaLex
Beyond the science | using technology-enabled services to accelerate decision making and drive efficiency gains
Regulatory Affairs • Pharmacovigilance • Regulatory Operations • Pharmaceutical Quality • Audit / Inspection Preparation
1001 - 5000
Description
• Program Analytical Test Methods into Softmax Pro to collect and analyze micro plate reader data in alignment with approved ATMs • Prepare associated documentation to include Configuration Specifications, Test Cases and Requirement Tracing Matrix
Requirements
• Working knowledge of biological characterization assays for GMP quality release of FDA regulated therapeutics (e.g. ELISA, Protein Absorption, and Cell Based Assays) • Minimum three years’ experience with the digital configuration of micro plate reader data acquisition and analysis SoftMax Pro Software • B.S/M.S in Cell, Molecular or Computational Biology
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