QC Scientist Bioassay - Site based, Redmond, WA

Role Summary

QC Scientist Bioassay - Site based, Redmond, WA. Responsible for QC analysis of in-process, drug substance, and drug product samples in support of GMP manufacturing operations at the Redmond, WA GMP facilities for biotherapeutic products. Role involves cell-based assays, collaboration with cross-functional teams, and ensuring timely, accurate GMP documentation.

Responsibilities

• Dive deep into cell-based assays to determine potency of innovative biologics and identify improvements.
• Collaborate with cross-functional teams to explore new possibilities and solutions.
• Share findings, ideas, and solutions in team settings and presentations.
• Keep up with trends in bio-pharmaceutical manufacturing and apply knowledge to inspire and lead.
• Ensure that curiosity-driven questions lead to measurable, impactful results.
• Perform routine/non-routine QC testing using cell-based assays, ELISA, and qPCR.
• Ensure timely and accurate completion of GMP documentation.
• Collaborate with Analytical Development to generate and approve protocols, reports, and documents for qualification and transfer of analytical methods.
• Conduct laboratory investigations, deviations, OOS, change controls, and CAPAs.
• Support equipment qualification (IQ, OQ, PQ).
• Create, maintain, and revise SOPs, methods, and related documents.
• Support QC lab operations including ordering supplies and maintaining equipment and lab spaces.
• Support client audit/inspection readiness and interact with regulatory agencies during inspections on analytical matters.
• Participate in daily and weekly operation meetings.

Qualifications

• BS in Biochemistry, molecular/cellular biology, chemistry, or related field with 3+ years of Quality Control experience in GMP biopharmaceutical or biotechnology industry.
• Knowledge of GMP regulations and experience with regulatory compliance inspections.
• Hands-on experience executing potency and impurity methods (cell-based assays, immunoassays, and qPCR).
• Laboratory experience with mammalian cell culture and cell banking.
• Ability to adapt, work in a fast-paced environment, and manage multiple projects and priorities.
• Excellent oral/written and interpersonal communication skills; proficiency with Microsoft Office Suite.

Skills

• Problem-solving mindset with a passion for learning and growth.
• Collaborative in sharing ideas and learning from others.
• Strong communication skills to convey complex ideas clearly.

Education

• BS in Biochemistry, molecular/cellular biology, chemistry, or related field.

Additional Requirements

• Site-based role in Redmond, WA.