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

Overview

Job Title: Senior QC Scientist, Raw Materials

Days: Monday to Friday.

Location: Site based, Redmond, WA

About Us: Just Evotec Biologics

We are a team driven by curiosity and a commitment to innovation. We aim to challenge the status quo, learn from each other, and push the boundaries of what’s possible.

#BeCureious — ask questions, explore, and grow with us.

The Role: Senior QC Scientist, Raw Materials

In this role, you’ll drive impactful projects, collaborate with cross-functional teams, and contribute to advancing our raw materials program.

This position oversees and participates in the sampling and testing of incoming raw materials prior to their use in cGMP manufacturing. The role requires extensive cGMP compliance experience, exceptional attention to detail, and experience designing and implementing efficiency improvements.

• 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 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.

• 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.

• 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.

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 market value. Additional total rewards include discretionary annual bonus and comprehensive benefits (Medical, Dental, 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.