Principal QC Scientist - Raw Materials - Site Based, Redmond, WA

Job Title: Principal QC Scientist, Raw Materials

Days: Monday to Friday.

Location: Site based, Redmond, WA

About Us: this is who we are

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?   #BeCureious with us and see where your curiosity can take you!

The Role: / your challenge, …in our journey

We’re looking for a passionate and curious Principal Scientist, QC Raw Materials 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 Principal Scientist, QC Raw Materials 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.

This position leads Quality Control projects supporting Just-Evotec’s GMP biotherapeutic manufacturing operations at the Seattle and Redmond, WA GMP facilities.  The role partners with Quality Assurance, Manufacturing Operations, Technical Operations, Materials Management, F&E, Process Development and EH&S functions to ensure GMP and regulatory compliance.

Responsibilities include oversight of GMP systems and spearheading initiatives to build processes for test quality and delivery using biological, biochemical, and physiochemical methods.  A proven track record of technical skills in these areas, as well as experience leading quality compliance initiatives is required.  Role ensures robust laboratory training process, leads GMP document life cycle management, and coordinates across internal functions in support of client program needs. This role requires strong project management and mentoring skills as well as a deep understanding of biologics analytical GMP raw materials inspection, analytical testing, and release.  Role also requires a keen attention to detail, excellent customer-service orientation, high degree of professionalism and organization, and strong written and verbal communication skills.

What You’ll Do:

• Provide technical and compliance guidance for raw materials group to ensure timely testing. 

• Lead method transfer and phase appropriate qualification/validation of analytical methods from Analytical Development or to QC as well as the transfer and validation of methods between manufacturing sites and subcontractors. 

• Ensure success of Quality Control functions through strategic and day-to-day mentorship. 

• Develop and maintain strategic plans, including outsourced activities and business continuity, to ensure cGMP testing needs are met across client programs. 

• Responsible for QC audit and inspection readiness, including support and preparation of responses to observations and ensuring response CAPAs are effective.  

• Identify gaps, design collaborative solutions and lead laboratory efficiencies and improvements. 

• Drive planning, coordination, and continuous improvement of methods, processes, and systems to assure the quality of testing. 

• Conduct laboratory investigations, deviations, OOS, change controls and CAPAs and provide technical expertise in cross-functional investigations.

• Act as process owner for equipment and software qualification (IQ, OQ, PQ).

• Develop and implement testing-related Quality Management System processes. Create, maintain, and revise QC SOPs and strategy documents that support the Quality Management System.  

• Manage program key performance