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

Just-Evotec Biologics • Redmond, WA

1d • Onsite

About The Position

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!

We’re looking for a passionate and curious Senior QC Scientist, 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 Senior QC Scientist, 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 oversees and participates in the sampling and testing of incoming raw materials prior to their use in cGMP manufacturing. This role works collaboratively with other teams to ensure that raw materials are released in a compliant manner prior to their need-by dates. The role requires extensive cGMP compliance experience, exceptional attention to detail, and experience designing and implementing efficiency improvements.

Requirements

• BS in Chemistry, or related field with 8+ years relevant Quality experience and 10+ years’ experience in industry, including a minimum of 3+ years of hands-on, industry experience managing a cGMP Raw Material team.
• Extensive experience with raw material sampling, including handling of powders and liquids, using aseptic techniques.
• Knowledge of cGMP raw materials tests including pH, conductivity, osmolality, moisture, appearance, FTIR, HPLC, etc.
• Knowledge of verification and validation of assays required for raw material testing.
• Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA).
• Extensive knowledge of GDPs, GMPs multi-compendial assays (USP, EP, JP).
• Excellent communication and collaboration skills.
• Attention to detail, highly organized, able to meet schedules and timelines and handle multiple priorities.

Responsibilities

• Lead a QC raw materials testing program to support commercial manufacturing.
• Oversee the inspection, sampling, and testing of incoming raw materials prior to use in manufacturing, according to US and EU GMP requirements.
• Ensure materials are sampled in accordance with SOPs, entered into the data management systems, and are available for use on time.
• Participate in the qualification of raw materials via external and in-house testing.
• Serve as subject matter expert in review of raw material specifications.
• Participate in vendor audits as a technical advisor.
• Oversee the daily routine activities of the raw materials group, provide data review, and ensure the operation remains compliant at all times.
• Collaborate with Quality Assurance, Manufacturing, Materials Management, external vendors, and other functions to ensure internal timelines, testing TAT, and team milestones are achieved.
• Author and maintain required cGMP documentation such as SOPs and guidance documents.
• Oversee verification of assays at external testing labs.
• Identify gaps, design collaborative solutions, and implement improvements.
• Participate in external testing labs QC laboratory investigations, deviations, OOS, and CAPAs.
• Onboard and qualify analytical equipment (e.g., FTIR) as resources permit.

Benefits

• Growth Opportunities
• Flexible Work Environment
• Inclusive Culture
• Innovative Projects
• A Place for Big Ideas
• 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

What This Job Offers

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