Associate Scientist - Bioassay

QC Associate Scientist - Bioassay

This role provides the QC analysis of raw materials, 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.
 

Responsibilities

• Perform routine/non-routine QC testing using by techniques such as cell-based assays, ELISA, and qPCR.
• 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 analytical methods.
• Conduct laboratory investigations, deviations, OOS, change controls and CAPAs
• Support equipment qualification (IQ, OQ, PQ).
• Create, maintain, and revise SOPs, methods and associated documents.
• Support all operations of the QC 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 analytical related matters.
• Participate in daily and weekly operation meetings.

Requirements

• BS in Biochemistry, molecular / cellular biology or chemistry or related field and 1 year plus of Quality Control experience in GMP biopharmaceutical or biotechnology industry.
• Knowledge of GMP regulations and experience with regulatory compliance inspections.
• Hands on experience in the execution of potency and impurity methods (cell-based assays, immunoassays, and qPCR).
• Laboratory experience with mammalian cell culture and cell banking.
• 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).

This job description is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Because job requirements evolve with the changing needs of Just-Evotec Biologics business, this description is subject to change and may be modified at any time, whether formally or informally.

The base pay range for this position at commencement of employment is expected to be $78,000 to $83,000; Base salary offered may vary depending on the 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.