Quality Control Bioassay Manager - Site Based, Redmond, WA

Role Summary

Quality Control Bioassay Manager responsible for the daily oversight of the QC Bioassay laboratory operations at GMP manufacturing facilities in Redmond, WA and Seattle, WA. Supports routine GMP operations, method transfer, validation, and method lifecycle activities; leads in-process and drug substance testing, training, GMP document authoring, and cross-facility process improvements. Drives collaboration with Analytical Development, Quality Assurance, Manufacturing, and other functions to meet timelines and quality objectives.

Responsibilities

• Provide hands-on leadership for the QC Bioassay lab operations; manage daily/weekly/monthly activities of staff and oversee group performance, data review, scheduling, and training.
• Oversee multiple QC analysts and direct management of individuals, including goal setting, performance feedback, skills development, and mentoring.
• Lead and guide QC Bioassay testing and method qualification in support of GMP Biologics manufacturing, including in-process, stability, drug substance and drug product release testing by cell-based assays, ELISA, and qPCR.
• Collaborate with Analytical Development to generate and approve protocols, reports, and other documents required for qualification and transfer of bioassay methods.
• Collaborate with Quality Assurance, Manufacturing, Material Management, and other functions to ensure internal timelines, testing TATs, and team milestones.
• Oversee laboratory investigations, deviations, OOS, change controls and CAPAs.
• Create, maintain, and revise QC Bioassay SOPs, methods and associated documents.
• Manage all aspects of the Bioassay labs including ordering supplies, maintaining equipment and lab spaces.
• Support client audit/inspection readiness plans and interact with regulatory agencies during inspections on Bioassay matters.
• Establish and publish KPI to track cGMP compliance for QC Bioassay; capture metrics for continuous improvement.
• Participate in daily and weekly operation meetings and Quality Management Reviews.

Qualifications

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

Skills

• Cell-based assays, ELISA, and qPCR
• GMP operations and method transfer/validation
• Bioassay method development, qualification, and lifecycle management
• Documentation and SOP development
• Laboratory leadership, scheduling, training, and mentorship
• Regulatory readiness and interaction with agencies

Education

• BS in Biochemistry, molecular/cellular biology or chemistry (as listed in Qualifications)