Senior Scientist Bioassay - Quality Control; GMP Site , Redmond, WA

Job Title: Senior Scientist, Bioassay – Quality Control (GMP)

Shifts: Day Shift, Monday–Friday, Core Hours 8:00am–5:30pm

Location: Seattle / Redmond, WA (Onsite)

We are seeking a GMP focused Senior Scientist, Bioassay to support QC operations for late stage and commercial biologics manufacturing. In this role, you will be a key contributor to ensuring the quality, consistency, and regulatory compliance of in‑process, drug substance, and drug product testing across our Seattle and Redmond GMP facilities. You will play a critical role in method execution, method lifecycle management, inspection readiness, and data integrity excellence—essential to our path toward commercialization.

This is a role for someone who is both scientifically sharp and operationally disciplined, who can think creatively while executing flawlessly in a regulated environment. Just is seeking a highly motivated individual who desires a significant opportunity to improve worldwide access to biotherapeutics. The QC Senior Scientist will provide the QC analysis of in‑process, drug substance and drug product samples in support of our GMP manufacturing operations at the Seattle and Redmond, WA GMP facilities.

These efforts support GMP manufacturing activities for biotherapeutic products.

• GMP Testing & Data Integrity
  :
  • Perform routine and non‑routine GMP QC testing using Bioassay methods including: cell‑based potency assays, ELISA (HCP, ProA, binding assays), and qPCR.
• Ensure ALCOA+ data integrity principles are followed in all documentation and electronic systems.
• Deliver high quality, timely analytical results to support batch release, stability, comparability, and in‑process control programs.
• Method Lifecycle & Technical Leadership
  :
  • Partner with Analytical Development to support method qualification, validation, transfer, and lifecycle management in alignment with ICH Q2/Q14 expectations.
  • Author, review, and approve GMP protocols, reports, method files, and technical assessments.
  • Serve as a subject matter expert (SME) for Bioassay methods during:
    • Internal audits
    • Client audits
    • Health authority inspections (FDA, EMA, PMDA)
• Quality Systems & Compliance
  :
  • Lead and support GMP investigations including: OOS, OOT, deviations, CAPAs, change controls.
  • Ensure investigations are scientifically sound, timely, and inspection ready.
  • Support PLI readiness, including document preparation, data traceability, and SME coaching.
• Equipment & Laboratory Operations
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  • Support equipment qualification and lifecycle (IQ/OQ/PQ, calibration, maintenance).
  • Maintain a state of audit readiness across QC labs, including logbook review, reagent and consumable management, environmental and safety compliance.
  • Contribute to continuous improvement initiatives to enhance throughput, robustness, and compliance.
• Leadership & Mentorship
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  • Provide on‑floor technical guidance to junior analysts.
  • Deliver training on GMP expectations, method execution, and data integrity.
  • Represent QC in cross‑functional meetings and operational planning sessions.

• BS in Chemistry, Biochemistry, Molecular Biology, or related field with 5+ years of GMP QC experience in biologics or biotechnology.
• Strong hands‑on experience with Bioassay techniques (ELISA, qPCR, HCP, ProA, cell‑based potency).
• Demonstrated experience supporting GMP inspections and regulatory compliance.
• Working knowledge of ICH, FDA, EMA, and USP guidelines relevant to QC testing.
• Experience with electrophoresis or chromatography data systems (e.g., CE, HPLC, Empower).
• Excellent communication skills and the ability to work cross‑functionally in a fast‑paced CDMO environment.
• Proven ability to manage multiple priorities, meet deadlines, and maintain high quality standards.

• Experience in late stage clinical or commercial QC operations.
• Prior involvement in PLI readiness or commercial launch activities.
• Familiarity with LIMS, ELN, and electronic data integrity systems.

• Growth Opportunities
  :
  We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship,…