Senior Scientist for QC Microbiology - Redmond WA
Senior Scientist for QC Microbiology - Redmond WA
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Job Description
Senior Scientist for QC Microbiology
JustEvotec Biologics is seeking a skilled Senior Scientist for QC Microbiology experience to join our dynamic team. This role provides the QC analysis of raw materials inprocess drug substance samples in support of our GMP manufacturing operations at our GMP facilities. These efforts support GMP manufacturing activities for biotherapeutic products.
This role is site based with the main location in the Redmond WA US.
Responsibilities
Perform QC Microbiology routine/nonroutine GMP operations including:
- Environmental Monitoring (sampling and plate reading).
- Water sampling and testing (e.g. Bioburden Endotoxin Total Organic Carbon).
- Product testing (e.g. Bioburden and Endotoxin).
- Microbial identification.
- Growth promotion.
Perform microbiological method validation/verification for new products.
Assure timely and accurate completion of GMP documentation.
Support QC management in the timely review of data.
Support the Contamination Control team by providing Environmental and Utility monitoring data.
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.
Provide onthefloor mentorship training and technical leadership for less experienced staff as an individual contributor.
Requirements
BS in Microbiology Biology or related field and min. 5 years of Quality Control experience in GMP biopharmaceutical or biotechnology industry.
Extensive laboratory experience with environmental monitoring and water sampling and testing (bioburden endotoxin TOC and conductivity).
Experience with microbial identification.
Knowledge of GMP USP ICH and other regulatory requirements and experience with regulatory compliance inspections.
Ability to adapt work in a fastpaced 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 JustEvotec 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 $91560 to $125350; Base salary offered may vary depending on the individuals skills experience and competitive market value. Additional total rewards include discretionary annual bonus comprehensive benefits to include Medical Dental and Vision shortterm and longterm 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.
Required Experience:
Senior IC
Employment Type
Full-Time
