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 at Just Evotec Biologics value curiosity and strive to push the boundaries of biologics development and manufacturing. We are building a team that thrives on scientific rigor, operational excellence, and a deep commitment to quality as we prepare for Process License Inspections and move toward commercial readiness.

• 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 subject matter expert for Bioassay methods during internal audits, client audits and health authority inspections (FDA, EMA, PMDA).
• Quality Systems & Compliance
  • Lead and support GMP investigations including OOS, OOT deviations, CAPAs and 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
  • Support equipment qualification and lifecycle (IQ/OQ/PQ, calibration, maintenance).
  • Maintain 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
  • 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.

• Required
  • 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 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.

The base pay range for this position at commencement of employment is expected to be $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.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation or veteran status.