Senior Scientist Bioassay - Quality Control (GMP) Site Based, Redmond, WA

About the role

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.

Responsibilities

• Perform routine and non routine GMP QC testing using Bioassay methods including: o Cell based potency assays o ELISA (HCP, ProA, binding assays) o 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.
• 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: o Internal audits o Client audits o Health authority inspections (FDA, EMA, PMDA)
• Lead and support GMP investigations including: o OOS, OOT, deviations o CAPAs o Change controls
• Ensure investigations are scientifically sound, timely, and inspection ready. Support PLI readiness, including document preparation, data traceability, and SME coaching.
• Support equipment qualification and lifecycle (IQ/OQ/PQ, calibration, maintenance).
• Maintain a state of audit readiness across QC labs, including: o Logbook review o Reagent and consumable management o Environmental and safety compliance
• Contribute to continuous improvement initiatives to enhance throughput, robustness, and compliance.
• Provide on the 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.

Requirements

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.

Preferred

• 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.

Benefits

Base pay range: $92,400 to $126,500; this is a salary exempt role. Base salary offered may vary depending on the individual's skills, experience and competitive market value.

Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, generous paid time off and paid holiday, wellness and transportation benefits.