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

Cyprotex • Redmond, WA

3d • Onsite

About The Position

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.

Requirements

• BS in Chemistry or related field with 8+ years relevant Quality and laboratory experience and 10+ years’ experience in industry.
• Expert understanding of cGMP's, FDA, USP, NSF regulations and relevant ISO and USP/EU compendia methods and experience with regulatory compliance inspections and responses.
• Proficient at technical writing including analytical methods, technical summary reports and 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.

Nice To Haves

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

Responsibilities

• 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 indicators to monitor performance and ongoing activities; includes meeting and exceeding internal stakeholder and customer expectations.
• Build and maintain expertise in the QC organization, through development of staff to ensure that the QC organization supports manufacturing operations and analytical development activities as required.
• 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.

Benefits

• Growth Opportunities: We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll 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: We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.
• Innovative Projects: You’ll 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 don’t just talk about thinking outside the box—we throw the box away. If you’ve got ideas, we want to hear them.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level