Scientist, SoftMax Pro Template Validation (On-site)
Merck
August 25, 2026
On-site
North Wales, PA
Operations
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.
Application: Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub as a current employee); application deadline is stated on the posting.
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.
Application: Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub as a current employee); application deadline is stated on the posting.