Quality Control Bioassay Manager - Site , Redmond, WA

Job Title
: QC Manager - Bioassay

Location: Redmond, WA

Shifts: Monday to Fridays, Days.

At Just Evotec Biologics
, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We're on a mission to create a place where curiosity isn't just encouraged—it’s celebrated.

Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #Be Cureious with us and see where your curiosity can take you!

We’re looking for a passionate and curious QC Manager to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.

As a QC Manager at Just Evotec Biologics
, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team.

Responsible for the daily oversight for the Quality Control Bioassay lab operations at the GMP manufacturing facilities in Redmond, WA and Seattle, WA. This position supports routine GMP operations, method transfer, validation, and method lifecycle activities at Just-Evotec. Responsibilities include in-process and drug substance sample testing, training of laboratory staff, GMP document authoring / revision, providing oversight in support of GMP operations and spearheading initiatives to build infrastructure and processes across both Washington state facilities.

• 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.

• 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.

• Growth Opportunities
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  We’re a company that believes in continuous learning and development. Whether it’s professional…