QC Senior Scientist - Bioassay

QC Senior Scientist - Bioassay

Just is seeking a highly motivated individual who desires a significant opportunity to improve worldwide access to biotherapeutics. We are looking for someone to join a fast paced, collaborative, and multidisciplinary team. This individual will join the Quality Control Bioassay team supporting the GMP manufacturing facilities in Redmond, WA and Seattle, WA. The role is responsible for conducting routine/non-routine testing and analysis of GMP product using methods such as ELISAs, qPCR, and cell-based assays at both Washington state facilities. The ideal candidate will have significant experience in cell-based methods with strong data analysis skills. Hands-on with cell-based, immune-chemical (e.g., absorbance, fluorescence and luminescence-based microplate assays), and molecular biology assays (i.e., qPCR) method execution is required.

Responsibilities:

• Perform routine/non-routine testing using diverse biological assay formats (e.g., cell-based, ELISA, qPCR).
• Ensure timely and accurate completion of GMP documentation.
• Support QC management in the timely review of data and reports.
• Provide on-the-floor mentorship, training and technical leadership as an individual contributor.
• 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.
• Create, maintain, and revise SOPs, methods and associated documents.
• Support all operations of the Bioassay labs including the ordering supplies and maintaining laboratory equipment and lab spaces.
• Support client audit/inspection readiness plans and interact with regulatory agencies during inspections on Bioassay related matters.
• Participate in daily and weekly operation meetings.

Required Qualifications:

• BS in Biochemistry, molecular / cellular biology or chemistry with a minimum of 8 years of Quality Control experience in GMP biopharmaceutical or biotechnology industry
• Extensive knowledge of GMP regulations and experience with regulatory compliance inspections
• Experience in the qualification and/or validation of release potency and impurity methods (cell-based assays, immunoassays, and qPCR)
• Ability to adapt, work in a fast-paced environment, manage multiple projects and priorities at the same time.
• Knowledge of statistical analysis for cell-based bioassay is preferred.
• Excellent oral/written and interpersonal communication skills; and a knowledge of Microsoft Office Suite (Excel, Word, PowerPoint)

Physical Requirements:

• Travel between Seattle and Redmond site required.
• Required to stand or sit for long periods of time while performing duties.

The base pay range for this position at commencement of employment is expected to be $90,000 to $140,000; Base salary offered may vary depending on individual’s 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.