Research Associate Lv. Iii

1 day ago

Richmond, Canada Lepzi Biotechnology Ltd. Full time

Lepzi Biotechnology Ltd. (LBio) is an innovative ground for the development of high-performance solutions for _in-vitro_ diagnostics. Our platform technology is designed to provide fast and reliable measurement of specific analytes in human whole blood and plasma for a wide range of medical conditions, including heart failure, kidney failure, preeclampsia, etc. New products in development include multiplex tests for simultaneous measurement of multiple analytes in a single assay cartridge.

We strongly believe that quality by design and a solid quality management system coupled with compliance to all applicable standards will contribute to successful product launches.

**Job Summary**

As a member of the Research and Development (R&D) Team, the Research Associate (level III) is responsible for performing a variety of tasks and experiments of diverse and complex scope to support the development of new assay products, production methods, and quality inspection procedures as per Lepzi Biotechnology internal procedures. This position will report to the Scientist or the Product Manager/Director of R&D.

**Responsibilities**
- Demonstrates in-depth knowledge and experience with R&D experimental design, product development, manufacturing, Quality Control (QC) inspection, troubleshooting, and root-cause analysis for lateral flow immunoassay technologies.
- Demonstrates in-depth understanding of the technology and components of the Lepzi assay platform.
- Demonstrates high proficiency for working in a regulated environment under the guidelines set by the Company to assure adherence to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Design Control and Work Safety.
- Manages project work for design, development and validation of assay products for _in vitro _diagnostics in consultation with the Product Manager/Scientist. Works under mínimal supervision and receives mínimal or no instruction on routine work.
- Performs, delegates, and reviews the execution of general laboratory tasks such as organization of work area, laboratory clean-up, equipment calibration, etc.
- Demonstrates high proficiency with the operation of laboratory and production equipment/instruments. Implements new equipment, methods, and procedures to support product development projects. Review maintenance records and identifies risk to process and/or product.
- [SC1] Manages R&D inventory and inventory systems (e.g., Access and Smartsheet) in cooperation with Product Manager/Scientist and other team members and drafts Purchase Orders.
- Prepares R&D production requests and plans resources in cooperation with Product Manager/Scientist. Plans and reviews the execution of experimental product batches under supervision.
- Maintains appropriate laboratory records, Quality Control (QC) and manufacturing documentation. Reviews experimental data and reports of team members to ensure completeness and accuracy of records.
- Prepares and reviews technical reports. Supports the preparation of documentation for DHF, Manufacturing, Quality, and regulatory submissions as directed by the Scientist or the Product Manager/Director of R&D.
- Performs literature research and provides summary reports as required.
- Organizes team meetings and small focus groups. Provides meeting agenda and records meeting notes and action items.
- Initiates brainstorming and troubleshooting activities and identifies solutions. Determines and coordinates follow-up actions and experimental work with other departments as required. Implements improvements and solutions to ideas.
- Provides updates, progress reports, and technical recommendations based on completed work to the Product Manager.
- Monitor team performance against project goals. Provides performance evaluations and motivates team members.
- Provides training, mentorship, and technical expertise to more junior team members to support the development of technical proficiency, scientific creativity, and collaboration. Provides oversight and leadership to more junior team members within assigned project teams.
- Plans and coordinates project activities within the R&D team to ensure effective execution of assigned product development projects
- Conducts all research/development work in a highly ethical and intellectually honest manner.
- Performs other duties or assumes additional responsibilities as required.

**Qualifications and Skills**
- Bachelor’s degree, preferably in biotechnology, microbiology, immunology, biochemistry, biology, or related science with minimum 5 years of relevant work experience, or Master's degree with a minimum 3 years of relevant work experience. Industry experience working on assay development and/or lateral flow assays will be preferred.
- Understands the scientific basis of biology, biochemistry, and/or chemistry and has the mindset to solve scientific questions in a creative way.
- Effective interpersonal and communication skills to closely collaborate with other team members

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