Quality Control Bioassay Manager - Site Based, Redmond, WA

Role Summary

QC Manager – Bioassay responsible for the daily oversight of Quality Control Bioassay lab operations at GMP manufacturing facilities in Redmond, WA and Seattle, WA. Includes routine GMP operations, method transfer/validation, and method lifecycle activities; duties span in-process and drug substance testing, staff training, GMP document authoring/revision, and cross-facility process improvement.

Responsibilities

• Provide hands-on leadership for the QC Bioassay lab operations; manage daily/weekly/monthly activities of staff, data review, scheduling, and training.
• Oversee multiple QC analysts; direct management of individuals, including goal setting, performance feedback, skills development, and mentoring.
• Lead and guide QC Bioassay testing and method qualification for GMP Biologics manufacturing (in-process, stability, drug substance, and drug product release testing) using cell-based assays, ELISA, and qPCR.
• Collaborate with Analytical Development to generate/approve protocols, reports, and other documents for qualification and transfer of bioassay methods.
• Coordinate with Quality Assurance, Manufacturing, Material Management, and others to meet internal timelines, testing turnaround times, and milestones.
• Oversee laboratory investigations, deviations, OOS events, change controls, and CAPAs.
• Create, maintain, and revise QC Bioassay SOPs, methods, and related documents.
• Manage all aspects of Bioassay labs, including supplies, equipment, and workspace maintenance.
• Support client audit/inspection readiness and interact with regulatory agencies on Bioassay matters.
• Establish and publish KPIs to track cGMP compliance for QC Bioassay and collect metrics for continuous improvement.
• Participate in daily/weekly operation meetings and Quality Management Reviews.

Qualifications

• BS in Biochemistry, molecular/cellular biology, or chemistry; 5+ years in pharmaceutical industry; 3+ years managing a cGMP QC laboratory.
• Direct leadership experience required.
• Experience in validation and transfer of release potency and impurity methods (cell-based assays, immunoassays, qPCR).
• Knowledge of regulatory requirements/guidelines (ICH, CFR, FDA) as related to drug-substance biological manufacturing and release/stability testing/method validation.

Skills

• Leadership and people management
• Bioassay method development/qualification and transfer
• Regulatory compliance and GMP knowledge
• Analytical techniques: cell-based assays, ELISA, qPCR
• Documentation: protocols, reports, SOPs
• Cross-functional collaboration and problem-solving

Education

• Bachelor‚Äôs degree in Biochemistry, Molecular/Cellular Biology, or Chemistry (minimum)

Additional Requirements

• Willingness to work on-site in Redmond, WA and Seattle, WA
• Travel not specified as a core requirement