QC Senior Scientist - Analytical
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 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
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Perform routine/non-routine QC testing using chromatographic and physiochemical methods.
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Ensure timely and accurate completion of GMP documentation.
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Collaborate with Analytical Development to generate and approve protocols, reports, and other technical documents required for the qualification and transfer of analytical methods.
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Conduct laboratory investigations, deviations, OOS, change controls and CAPAs.
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Support equipment qualification (IQ, OQ, PQ).
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Support QC management in the timely review of data.
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Develop, revise, and review SOPs, methods and associated documents.
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Support all operations of the QC labs including the ordering supplies, maintaining laboratory equipment and lab spaces, , and logbook reviews.
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Support client audit/inspection readiness plans and interact with regulatory agencies during inspections on analytical related matters.
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Participate in daily and weekly operation meetings.
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Provide on-the-floor mentorship, training and technical leadership for less experienced staff as an individual contributor.
Requirements
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BS in Chemistry, Biochemistry, or related field with a minimum of five years of Quality Control experience in GMP biopharmaceutical or biotechnology industry.
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Extensive laboratory experience with either HPLC / UPLC chromatography systems or capillary electrophoresis techniques.
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Experience with capillary electrophoresis or chromatography data systems.
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Knowledge of GMP regulations and experience with regulatory compliance inspections.
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Ability to adapt, work in a fast-paced environment, manage multiple projects and priorities at the same time.
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Excellent oral/written and interpersonal communication skills; and a knowledge of Microsoft Office Suite (Excel, Word, PowerPoint).
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Ability to work independently and with others to accomplish goals and priorities.
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Must possess effective time management skills, demonstrate initiative, resourcefulness and flexibility to work independently and as part of a team.
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 $92,400 to $126,500; 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.
Top Skills
What We Do
Evotec is a biotechnology company that is committed to advancing drug discovery and development. Through flexible business models, we collaborate with pharmaceutical companies, biotechs, foundations, and government agencies on a substantial scale. We believe that by working together, we can make a difference in the lives of patients.
Our Pipeline Co-Creation model represents our adaptable, multi-modality, fully integrated end-to-end approach to drive collaborations and services across all phases of drug discovery and development – from discovery of novel targets to achieving Proof of Concept in the clinic and into commercial manufacturing.
We aspire to contribute data-driven disease understanding and early disease relevance in humans to bring the probability of success up. We select the right modality, which is then propelled forward on our platforms by our passionate people striving for the fastest and most effective ways towards patient impact. This is enabled by convergence of human ingenuity with data and AI.
We also offer specific solutions, products, and CRO/CDMO-like services, always in support of the Biopharma R&D innovator. Our more than 4,000 scientists work closely with numerous partners concurrently, delivering fully integrated research and development portfolios or individual projects with the highest quality standards and efficiency, coupled with great science, passion, engagement, and communication.
