Site Analytical Steward - QC

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.

• 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.

• 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.

• 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).

• 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).