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10 days old

Clinical Lab Process Engineer - San Diego, CA

Kelly Services
La Jolla, CA 92037
**Clinical Laboratory Process Engineer - San Diego, CA**


We are looking for a Clinical Laboratory Process Engineer who will be responsible for developing and scaling the clinical laboratory processes for cutting-edge multi-omic assays for novel applications in Oncology.


This position will define and scale production processes applicable to a high-throughput production or molecular testing environment, including evaluating and characterizing equipment and reagents, designing and testing manufacturing processes, and drafting documentation including protocols, reports and operating instructions. The role will work closely with operations, product development, software development groups, and quality assurance. The ideal candidate will have experience interfacing with development teams, leading teams from concept to launch, facilitating transfer of lab protocols from product development into a clinical laboratory, and driving data based decisions.


**Specific Job Responsibilities**

Analyze workflows, identify bottlenecks, and develop solutions to improve efficiency, throughput, cost, and quality

Leverage an understanding of molecular biology and biochemistry to troubleshoot analytical and preparative processes

Apply scientific methods and engineering skills to improve the scalability sample processing workflows

Develop and validate test methods for new reagents and instruments, including NGS oligos and molecular diagnostics equipment.

Design, characterize, and execute new laboratory equipment qualification processes within an NGS setting.

Participate in the development of product plans, evaluation of processes and process risk, and development of project timelines.

Ensure laboratory activities are performed in compliance with procedures and safety guidelines when handling, storing, and disposing of hazardous or biohazardous materials.

Work to source cheaper alternative reagent sources where possible with the intent of reducing COGS without compromising assay quality

Work with the Laboratory Operations and R&D teams to continually refine laboratory processes with the aim of reducing TAT without sacrificing quality.

Provide dashboards that incorporate laboratory inventory numbers and records to assist supply chain teams in maintaining adequate stock levels of key materials required for assay execution

Work to identify and implement LIMS features in partnership with the Software Engineering and Lab Operations teams that further streamline current laboratory workflows.

Author, execute and document test plans and Standard Operating Procedures (SOPs) for automated workflows

This role requires meticulous recordkeeping, excellent attention to detail, and the ability to multi-task and be flexible with assignments and schedules.


**Qualifications:**

B.S. in biochemistry, molecular biology, bioengineering, or related fields preferred. M.S. is a plus.

4+ years of experience in the life sciences / biotech industry working in process engineering, R&D, or systems engineering including hands on experience in laboratory automation and liquid handling.

Experience with product development including process validation, equipment qualification, tech transfer, and process characterization required.

Statistical background for data analysis, process monitoring and QC.

Theoretical and practical knowledge of Next Generation Sequencing sample preparation workflows and applications required.

Experienced in defining requirements for lab workflows and LIMS systems.

Expertise in molecular biology.

Experience with nucleic acid extraction technologies.

Experience with Six Sigma, CIP, Root Cause Analysis techniques.

Demonstrated success in technical proficiency, creativity and collaboration with others. Experience in design of studies for the evaluation and qualification of NGS-related equipment is desired.

Experience with ISO quality standards preferred.

Experience with automated laboratory equipment such as robotic liquid handlers and qPCR/ddPCR instruments.

Effective organizational and time management skills. Highly energetic and self-motivated. Able to work independently and as part of a team.

Excellent verbal and written communication skills and willingness to collaborate cross-functionally.


**_For immediate consideration apply today!_**


**_Questions? Please reach out to Dustin at DUSG877@kellyservices.com_**


**_\#TJP2021_SPEC_**


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-05-03 Expires: 2021-06-03

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Clinical Lab Process Engineer - San Diego, CA

Kelly Services
La Jolla, CA 92037

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