Lepzi Biotechnology Ltd.
Position: Full-time, permanent
As a member of the Research and Development (R&D) Team, the Research Associate is responsible for performing a variety of tasks and experiments of a diverse and complex scope to support the development of new assay products, production methods and quality inspection procedures and per Lepzi Biotechnology internal procedures. This position will report to the Scientist or the Product Manager/Director of R&D.
- Manages the project work for design, development and validation of assay products for in vitro diagnostics in consultation with the Product Manager. Works under general supervision and receives minimal or no instructions on routine tasks.
- Plans and coordinates project activities with the R&D team and members of other departments (e.g., Manufacturing, Quality Control, etc.) to ensure effective execution of assigned product development project.
- Provides updates, progress reports and technical recommendations based on completed work to the Product Manager. May act as R&D team lead.
- Plans training. Provides training, mentorship, and technical expertise to more junior team members to support the development of technical proficiency, scientific creativity, and collaboration.
- Performs and evaluates experiments of a moderate to high complexity.
- Provides supervision, training, and mentorship for more junior team members to support the development of technical proficiency, scientific creativity and collaboration.
- Prepares production request and plans resources in cooperation with Product Manager/Scientist.
- Demonstrates in-depth knowledge of the technology and principles for lateral flow immunoassays and experience with R&D experimental design, product development, manufacturing, QC inspection, troubleshooting and root cause analysis for lateral flow immunoassay technologies.
- Collates, analyzes, summarizes and reports data generated from experiments performed. Draws conclusions from experimental findings and determines follow-up actions.
- Demonstrates proficiency with operation of laboratory and production equipment/instruments. Implements new equipment, methods and procedures to support product development projects. Reviews maintenance records and identifies risk to process and/or product.
- Presents data to team meetings and to small focus groups. Provides meeting agenda and records meeting notes and action items in cooperation with Product Manager/Scientist.
- Initiates brainstorming and troubleshooting activities and identifies solutions.
- Performs literature research and provides summary reports as required.
- Prepares, maintains, and reviews laboratory records, technical reports. Supports the preparation of documentation for DHF, Manufacturing, Quality, and regulatory submissions.
- Demonstrates high proficiency level 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 Worker’s Safety.
- Performs, delegates, and reviews the execution of general laboratory tasks such as organization of work area, laboratory clean up, inventory count, equipment calibration, etc.
- Schedules, and reviews work. Determines follow-up actions and experimental work.
- Plans and reviews the execution of experimental product batches under supervision.
- Manages R&D inventory and inventory systems (e.g., Access and Smartsheet) in cooperation with Product Manager/Scientist and other team members.
- Expected to identify and communicate issues and concerns and offer solutions and improvements to supervisor / manager.
- 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 3 years of relevant work experience, or Master’s degree with minimum 1 year of relevant work experience.
- Understands the scientific basis of biology, biochemistry, and/or chemistry.
- Effective interpersonal skills, oral and written communication skills.
- Experience working under GLP and GMP.
- Experience using computer applications including spreadsheets, e-mail, word-processing software & web-based systems.
- Strong attention to details.
Please send applications to firstname.lastname@example.org