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 samplesin 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 chromatographic and physiochemical 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 analytical 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 analytical 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.
Requirements
BS in Chemistry, Biochemistry, or related fieldwith a minimum of five years of Quality Control experience in GMP biopharmaceutical or biotechnology industry.
Extensive laboratory experience with either HPLC / UPLC chromatography systems or capillary electrophoresis 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.
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.
What makes us unique
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Our business model
With Evotec’s Action Plan 2025 “The data-driven R&D Autobahn to Cures”, our goal is to stay competitive in the ever evolving life science industry. Together for medicines that matter.
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Our expertise
Togehter, we are creators and turn imaginations into cures. With Evotec, a smart idea can unfold and mature, with the help of our high expertises and cutting-edge technologies.
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Our team
Our collaborative and trustful work environment enables solution-oriented discussions among colleagues. We inspire each other to great aspirations and know that, together, we’ll go further.
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Success Profile
Cultural fit and soft skills are important factors for success. Check out the traits we’re looking for:
Success Profile
Cultural fit and soft skills are important factors for success. Check out the traits we’re looking for:
- Curiosity
- Resilient
- Creative mindset
- Teamplayer
- Forward-thinking
- Adaptable
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