Site Analytical Steward - QC

Scorpion Therapeutics

Houston (TX)

On-site

USD 65,000 - 169,000

Full time

3 days ago
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Benefits offered by this job

Company bonus
401(k)
Medical/dental/vision insurance
Flexible benefits
Life insurance
Time off
Well-being programs

Job summary

Scorpion Therapeutics in Houston seeks a Site Analytical Steward to provide day-to-day analytical support as the site stands up small molecule and oligonucleotide Drug Substance testing. You will perform hands-on problem solving and support investigations of aberrant data with mentorship from the Analytical Molecule Steward.

Responsibilities include batch release data review, investigations of out-of-spec results, deviations review, method transfer, equipment qualification, and support for

Qualifications

  • BS in a related science field and 3–5 years GMP lab experience.
  • Proficiency with chromatographic, spectroscopic, and/or microbiological assays.

Responsibilities

  • Support technical review of test data for batch release and stability testing.
  • Assist investigations into out-of-spec results with root cause analysis under mentorship; troubleshoot equipment/methods.
  • Contribute to regulatory/technical reports and memos; evaluate new technologies.

Skills

GMP compliance
Analytical problem-solving
Communication skills
Mentorship & coaching

Education

BS in related science field

Job description

Position Overview

The Site Analytical Steward provides day-to-day analytical technical support for the Houston site as it stands up small molecule and oligonucleotide Drug Substance (DS) testing capability, performing hands-on problem solving and supporting investigations of aberrant data. The role grows technical depth and independence over time, with mentorship from the Analytical Molecule Steward.

Key Objectives/Deliverables
  • Technical Review & Batch Support: Support technical review of test data associated with batch release; increase responsibility for routine batch and stability testing review/release.
  • Investigation Support: Support investigations into out-of-spec results; root cause analysis under mentorship; troubleshoot equipment/methods; perform investigational testing; communicate with business partners.
  • Continuous Improvement: Contribute to regulatory/technical reports and memos; evaluate new technologies.
  • Training & Development: Participate in structured mentoring; support QC training as capability develops; mentor/coaching to QC analysts.
  • Deviations & Change Controls: Support review of change controls/deviations; document results in accordance with GMP.
  • Site Readiness Support: Support compliant lab operations, SOP/training development, safety programs; communicate effectively; support protocol-driven studies and lead equipment qualification/method transfer during startup (with mentorship).
  • Inspection Support: Support inspection readiness as directed.
  • Method Support/Benchwork: Support method transfer strategies; benchwork for development/validation/transfer; monitor method/process performance.
Basic Requirements
  • BS in a related science field + 3-5 years GMP lab experience.
  • Proficiency/strong development in chromatographic, spectroscopic, and/or microbiological assays.
  • Ability to work in lab with PPE.
  • Understanding of compliance/regulatory expectations (build depth under mentorship).
  • Problem-solving/analytical thinking; continuous-improvement mindset in a fast-moving startup.
  • Strong communication and ability to receive/apply mentorship.
  • Proficiency with computer systems.
  • Authorized to work in the US full-time; no visa sponsorship.
Additional Preferences
  • Experience with small molecules/oligonucleotides/peptides/proteins.
  • Familiarity with cGMP drug substance manufacturing.
  • Interest in advancing to a senior analytical steward role.
  • Experience/interest in greenfield/startup activities (equipment qualification, method transfer).
Benefits/Compensation (as stated)
  • Anticipated wage: $65,250-$169,400; possible company bonus; comprehensive benefits (incl. 401(k), medical/dental/vision, flexible benefits, life insurance, time off, well-being benefits).
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