Methods Specialist - Bioassay, Validation & Transfer

Scorpion Therapeutics

Omaha (NE)

On-site

USD 60,000 - 90,000

Full time

10 days ago

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Benefits offered by this job

Annual bonus
Medical/dental/vision insurance
401(k)
Paid holidays
Vacation
Sick/compassionate days

Job summary

Scorpion Therapeutics is seeking a skilled Analyst to support complex data analysis and biomaterials remediation across bioassay platforms. You will author remediation protocols and regulatory submissions, while coordinating cross-site method transfers and training.

1–3 years bench experience in in‑vitro bioassays and USDA familiarity are required. Strong technical writing and cross‑functional collaboration are essential as you help ensure robust, compliant methods and sustained performance

Qualifications

  • 1–3 years hands‑on bench experience in in‑vitro bioassay development/testing/troubleshooting.
  • 1–3 years in animal health environments (QC, R&D, and/or Technical Support) with familiarity with USDA requirements.
  • Expertise in at least one bioassay platform (ELISA, virus titration, HA/HI); data analysis/trending.
  • Strong technical writing; effective cross‑functional communicator.

Responsibilities

  • Support complex data analysis and trending to identify non-robust or out-of-specification methods; conduct biomaterials assessments, inventory reviews, and gap analyses.
  • Perform bench-level remediation across test platforms (live bacterial/virus titration & identification; ELISA for complex multivalent vaccines and in-process materials).
  • Author method remediation protocols, validation reports, and USDA regulatory submissions; update internal/regulatory procedures.
  • Support post-remediation change control assessments and verification of sustained method performance.
  • Participate in/lead cross-functional site-to-site analytical method transfer projects; coordinate timelines/deliverables.
  • Assess site capabilities (skills, instrumentation, lab operations) and implement remediation/training plans.
  • Provide hands‑on training during transfers and oversee transfer documentation/validation reports.
  • Support post‑transfer monitoring to confirm robustness and resolve residual issues.
  • Track progress, manage risks, and report metrics using internal systems; present updates and risk mitigations.

Skills

Bioassay development
Data analysis/trending
Cross-functional communication
Technical writing

Education

Bachelor’s degree in Biology, Genetics, Immunology, Microbiology, Virology, or related biological science

Tools

ELISA
Virus titration
HA/HI

Job description

Scorpion Therapeutics is seeking a skilled Analyst to support complex data analysis and biomaterials remediation across bioassay platforms. You will author remediation protocols and regulatory submissions, while coordinating cross-site method transfers and training.

1–3 years bench experience in in‑vitro bioassays and USDA familiarity are required. Strong technical writing and cross‑functional collaboration are essential as you help ensure robust, compliant methods and sustained performance

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