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 whats possible. Were on a mission to create a place where curiosity isnt just encouragedits celebrated.

Are you someone who asks questions seeks answers and isnt afraid to go deeper #BeCureious with us and see where your curiosity can take you!

The Role: / your challenge in our journey

Were looking for a passionate and curious Principal Scientist QC Raw Materials to join our team. If youre excited by new challenges solving complex problems and learning every step of the way you might just be the perfect this role youll 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 youll have the freedom to ask the hard questions think outside the box and find creative solutions that push us forward. Its 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-EvotecsGMP biotherapeutic manufacturing operations at the Seattle and Redmond WA GMP rolepartnerswith Quality Assurance Manufacturing Operations Technical Operations Materials Management F&E ProcessDevelopmentand EH&S functions to ensure GMP and regulatory compliance.

Responsibilities includeoversight ofGMP systems and spearheading initiatives to build processes fortest quality and delivery usingbiological biochemicaland physiochemicalmethods.A proven track record of technical skills in these areas as well as experience leading quality compliance initiativesis ensures robust laboratory training process leads GMP document life cycle management and coordinates across internal functions in support of client program needs. This rolerequiresstrong project management and mentoring skills as well as a deep understanding of biologics analytical GMP raw materials inspection analytical testing and also requiresa keenattention to detailexcellent customer-service orientationhighdegree of professionalism and organizationand strong written and verbal communication skills.

What Youll Do:

• Provide technical and compliance guidance for raw materials group to ensuretimelytesting.

• 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 andmaintainstrategicplans including outsourced activities and business continuity to ensure cGMP testing needs are met across client programs.

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

• Identifygaps design collaborativesolutionsand lead laboratory efficiencies and improvements.

• Drive planning coordination and continuous improvement of methods processes and systems toassurethe 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. Createmaintain and revise QC SOPs and strategy documents that support the Quality Management System.

• Manage program key performance indicators tomonitorperformance and ongoing activities; includes meeting and exceeding internal stakeholder and customer expectations.

• Build andmaintainexpertisein the QCorganizationthroughdevelopmentof staff to ensure that the QC organization supports manufacturing operations and analytical development activities asrequired.

• Collaborate with Quality Assurance Manufacturing Material Management and other functions to ensure internal timelines and team milestones are achieved.

• Participate in daily and weekly operation meetings.

• Provide on-the-floor mentorship training and technical leadership for less experienced staff as an individual contributor.

Who You Are:

• BS in Chemistry or related fieldwith 8 years relevant Quality and laboratory experience and 10 years experience in industry.

• Expert understanding of cGMPs FDA USP NSF regulations and relevant ISO and USP/EU compendia methodsand experience with regulatory compliance inspections and responses.

• Strong project management experience with client interaction and KPI management skills preferred.

• Proficient at technical writing including analytical methods technical summaryreportsand Standard Operating Procedures.

• Extensive laboratory experience with relevant laboratory procedures including development troubleshooting and optimization.

• Ability to adapt work in a fast-paced environment manage multiple projects and priorities at the same time.

• Excellent oral/written and interpersonal communication skills; and a knowledge of Microsoft Office Suite (Excel Word PowerPoint).

• Ability to work independently and cross-functionally to accomplish goals and priorities.

Why Join Us:

• Growth Opportunities: Were a company that believes in continuous learning and development. Whether its professional courses mentorship or new projects well help you grow.

• Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life. This role is site based.

• Inclusive Culture: Were committed to building a diverse and inclusive environment where everyones voice is valued and curiosity is encouraged.

• Innovative Projects: Youll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.

• A Place for Big Ideas: We dont just talk about thinking outside the boxwe throw the box away. If youve got ideas we want to hear them.

Are You Still Curious

If youve read this far then chances are youve got a curious mindjust like us. So what are you waiting for Take the leap and apply today. We cant 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 $112560 - $140000; Base salary offered may vary depending on the individuals 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.