- Provide hands-on leadership for the QC Sample Management operations; management of daily/weekly/monthly activities of staff and operational oversight of group, data review, schedule, and training.
- Oversee multiple QC technicians across both Washington sites and directly manage individuals (includes goal setting, performance feedback, skills development, and mentoring.)
- Manage stability study initiation (set downs) and pulls for cell banks, starting materials, intermediates, drug substances, and drug products.
- Manage reference standard and critical reagent programs, including creation, qualification, and inventory.
- Author stability protocols, interim reports, and reports for stability studies in collaboration with Analytical Development.
- Manage, report, and trend stability data. Escalate trends and support associated investigations, including: temperature excursion assessments, client and regulatory requests, and investigational testing.
- Own and support stability and sample management-related Deviations, CAPAs, and Change Controls. Drive related improvements.
- Participate in the deployment and configuration of software systems for stability and sample management (e.g., LIMS)
- Collaborate with Quality Assurance, Manufacturing, Material Management, and other functions to ensure internal timelines, testing TAT, and team milestones are achieved.
- Create, maintain, and revise QC SOPs, methods, and associated documents.
- Manage all aspects of the sample management labs including ordering supplies and maintaining laboratory equipment, stability chambers, and lab spaces.
- Support inspection and client audit readiness plans. Serve as subject matter expert for and sample management related topics.
- Establish and publish Key Performance Indicators (KPI) to track cGMP compliance for stability studies and sample management. Capture metric information for use in continuous improvement of areas of responsibility.
- Participate in daily and weekly operation meetings and Quality Management Reviews.
- Bachelor's Degree with 10+ years of relevant experience within the pharmaceutical industry OR MS with 8+ years of relevant experience within the pharmaceutical industry.
- Experience in managing GMP stability studies across all phases of drug development.
- Direct leadership experience required.
- Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA) as they relate to drug substance and drug product stability testing.
- Travel between Seattle and Redmond sites required.
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Quality Control Manager - Redmond, United States - Just - Evotec Biologics
Description
Just is seeking a highly motivated individual who desires a significant opportunity to improve worldwide access to biotherapeutics. We are looking for someone to join a fast paced, collaborative, and multidisciplinary team. This individual will join the Quality Control leadership team supporting the GMP manufacturing facilities in Redmond, WA and Seattle, WA. As the QC Stability and Sample Management Manager, you will be responsible for the daily oversight for the QC stability and sample management operations in support of routine GMP operations at Just-Evotec. The ideal candidate will have commercial GMP experience in supporting stability and sample management programs.
Responsibilities:
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.
