Evotec · 20 hours ago
Quality Control Bioassay Manager - Site Based, Redmond, WA
Redmond, WA
Full-time
Onsite
Mid, Senior Level
$92K/yr - $126K/yr
5+ years expJust Evotec Biologics is a forward-thinking team focused on innovation and curiosity. The QC Manager will oversee the Quality Control Bioassay lab operations, manage staff, and ensure compliance with GMP standards while driving impactful projects.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Provide hands-on leadership for the QC Bioassay lab operations; management of daily/weekly/monthly activities of staff and 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 the ordering supplies and maintaining laboratory equipment and lab 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 use in continuous improvement of areas of responsibility
Participate in daily and weekly operation meetings and Quality Management Reviews
Qualification
Required
BS in Biochemistry, molecular / cellular biology or chemistry with a minimum of 5 + years of relevant experience within the pharmaceutical industry and a minimum of 3 + years of hands-on, industry experience managing 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) as they relate to drug substance biological manufacturing and release / stability testing / method validation
Benefits
Discretionary annual bonus
Comprehensive benefits to include Medical, Dental and Vision
Short-term and long-term disability
Company paid basic life insurance
401k company match
Flexible work
Generous paid time off
Paid holiday
Wellness and transportation benefits
Company
Evotec
Evotec is a pharmaceutical and life science company that provides drug discovery and gene therapy solutions.
5001-10000 employees
H1B Sponsorship
Evotec has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2023 (2)
2022 (2)
2021 (3)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$746.74MKey Investors
Bill & Melinda Gates FoundationKorea Advanced Institute of Science and TechnologyOpen Philanthropy
2025-05-07Grant· $2.5M
2025-01-22Grant
2023-12-19Grant· $2.5M
Leadership Team
Christian Wojczewski
CEO
Claudia Karnbach
EVP, Global Head of Partnerships and Alliances
Recent News
2026-01-07
Company data provided by crunchbase