Quality Control Bioassay Manager - Site Based, Redmond, WA

Role Summary

Quality Control Bioassay Manager responsible for the daily oversight of Quality Control Bioassay lab 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, trains laboratory staff, authors/revises GMP documents, and drives initiatives to build infrastructure and processes across both Washington facilities.

Responsibilities

• Provide hands-on leadership for the QC Bioassay lab operations; manage daily/weekly/monthly activities of staff and provide operational oversight of group, data review, schedule, and training.
• Oversee multiple QC analysts and direct management of individuals, including goal setting, performance feedback, skills development, and mentoring.
• Lead and provide guidance for QC Bioassay testing and method qualification in support of GMP Biologics manufacturing, including in-process, stability, drug substance and drug product release testing by techniques such as cell-based assays, ELISA, and qPCR.
• Collaborate with Analytical Development to generate and approve protocols, reports, and other technical documents required for the qualification and transfer of bioassay methods.
• Collaborate with Quality Assurance, Manufacturing, Material Management, and other functions to ensure internal timelines, testing TAT and team milestones are achieved.
• 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 and maintaining laboratory equipment and spaces.
• Support client audit/inspection readiness plans and interact with regulatory agencies during inspections on Bioassay related matters.
• Establish and publish Key Performance Indicators (KPI) to track cGMP compliance for QC Bioassay; capture metric information for continuous improvement.
• Participate in daily and weekly operation meetings and Quality Management Reviews.

Qualifications

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

Education

• BS in Biochemistry, molecular/cellular biology or chemistry