Senior Scientist Bioassay - Site Based, Redmond, WA

Cyprotex • Redmond, WA

14h • Onsite

About The Position

We’re looking for a passionate and curious Senior Scientist 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 Scientist Bioassay 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. Just is seeking a highly motivated individual who desires a significant opportunity to improve worldwide access to biotherapeutics. The QC Senior Scientist will provide the QC analysis of in-process, drug substance and drug product samples in support of our GMP manufacturing operations at the Seattle and Redmond, WA GMP facilities. These efforts support GMP manufacturing activities for biotherapeutic products.

Requirements

• BS in Chemistry, Biochemistry, or related field with a minimum of five years of Quality Control experience in GMP biopharmaceutical or biotechnology industry.
• Extensive laboratory experience with either Bioassay (ELISA; PCR; HCP; ProA; cell -based potency) techniques.
• Experience with capillary electrophoresis or chromatography data systems.
• Knowledge of GMP regulations and experience with regulatory compliance inspections.
• 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 with others to accomplish goals and priorities.
• Must possess effective time management skills, demonstrate initiative, resourcefulness and flexibility to work independently and as part of a team.

Responsibilities

• Perform routine/non-routine QC testing using Bioassay (Cell-based Potency ELISA; PCR; HCP; ProA) methods.
• Ensure timely and accurate completion of GMP documentation.
• Collaborate with Analytical Development to generate and approve protocols, reports, and other technical documents required for the qualification and transfer of Bioassay methods.
• Conduct laboratory investigations, deviations, OOS, change controls and CAPAs.
• Support equipment qualification (IQ, OQ, PQ).
• Support QC management in the timely review of data.
• Develop, revise, and review SOPs, methods and associated documents.
• Support all operations of the QC labs including the ordering supplies, maintaining laboratory equipment and lab spaces, , and logbook reviews.
• Support client audit/inspection readiness plans and interact with regulatory agencies during inspections on Bioassay related matters.
• 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
• 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, generous paid time off and paid holiday, wellness and transportation benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1-10 employees