Scientist, SoftMax Pro Template Validation (On-site)

Scientist, Large Molecule Analytical North American GMP Operations (North Wales, PA) Responsibilities Build SoftMax Pro templates for relative potency, HCP, and ProA assays; ensure accurate data capture, processing, and reporting. Manage SoftMax Pro template validation timelines with Large Molecule Assay Validation, Quality Assurance, and commercial labs. Author/approve template validation deliverables (requirements/configuration specs, test cases, QA summary reports). Run test-case dry runs to verify formula logic; troubleshoot template issues and implement improvements. Support training and transfer of validated templates; own change controls for new/revised templates. Ensure work follows ALCOA principles and applicable SOPs/quality/regulatory expectations. Execute potency and residual ELISA methods. Occasional irregular hours (evenings/weekends) as needed. Qualifications Bachelor’s degree in biology/biochemistry or related science plus 3 years’ relevant experience with SoftMax Pro, analytical development/validation and/or QC. Master’s degree in related field. Required skills/experience Proven SoftMax Pro template building/usage; strong data processing (curve fitting, calculations, reporting). ELISA and cell-based relative potency and/or residual ELISA experience. ALCOA documentation adherence; strong organization and timeline/deliverable management. Ability to identify/resolve technical issues, work independently, communicate/collaborate, and use change control. Preferred Regulated environment (GMP/GLP), method development/analytical validation, lifecycle management/regulatory submissions; USP/EP/ICH/FDA knowledge. Benefits (as stated) medical/dental/vision 401(k) paid holidays vacation compassionate and sick days annual bonus/long-term incentive if applicable. #J-18808-Ljbffr Scorpion Therapeutics