Quality Control Bioassay Manager - Site Based, Redmond, WA

QC Manager - Bioassay

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 encouragedit's celebrated.

Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCurious 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.

What You'll Do :

• 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.

Who You Are :

Why Join Us :

Are You Still Curious? If you've read this far, then chances are you've got a curious mindjust like us. So, what are you waiting for? Take the leap and apply today. We can't wait to see where your curiosity leads youand how it will shape the future of Just Evotec Biologics.

Let your curiosity guide your career#BeCurious and explore the endless possibilities at Just Evotec Biologics!

The base pay range for this position at commencement of employment is expected to be $92,400 to $126,500; Base salary offered may vary depending on the individual's skills, experience and competitive market value. Additional total rewards include 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 and paid holiday, wellness and transportation benefits.

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.