Biomedical Specialist - Biomanufacturing Facility

Cedars-Sinai•West Hollywood, CA

8d•$37 - $57•Onsite

About The Position

The Cedars-Sinai Biomanufacturing Center (CBC) is a state-of-the art facility that comprises of a cGMP cell manufacturing facility housing multiple cleanroom cell production suites and process development rooms for producing the next generation of cell and gene therapies. With world class expertise in stem cell (iPSC) biology, bioprocessing, translational, regulatory and manufacturing, Cedars-Sinai is committed to pushing the frontiers of medicine and discovering new technologies and innovations that will impact how we diagnose and treat disease. The Biomedical Specialist participates on wet- and dry- laboratory projects and may execute tasks requiring compliance with all Federal and State accrediting agency requirements and/or GLP. Performs process development, validation, qualification and writing SOPs. Proactively completes assigned projects, and uses knowledge and experience to create appropriate documentation and provide communication, guidance, and advice that contributes to the success of projects. May train entry level staff. Performs routine and increasingly complex laboratory tasks and procedures and develops technical expertise in one or more areas relevant to research or collaborative projects. Responsibilities include ordering and maintenance of lab equipment, and vendor management. Participates in research and/or collaborative activities involving all aspects of the research or protocol process, including investigation, technical, testing/validation of results, and report findings. This position will be supporting both the manufacturing operations team and the automation team.

Requirements

Participates on wet- and dry- laboratory projects
May execute tasks requiring compliance with all Federal and State accrediting agency requirements and/or GLP
Performs process development, validation, qualification and writing SOPs
Proactively completes assigned projects
Uses knowledge and experience to create appropriate documentation and provide communication, guidance, and advice that contributes to the success of projects
May train entry level staff
Performs routine and increasingly complex laboratory tasks and procedures
Develops technical expertise in one or more areas relevant to research or collaborative projects
Ordering and maintenance of lab equipment
Vendor management
Participates in research and/or collaborative activities involving all aspects of the research or protocol process, including investigation, technical, testing/validation of results, and report findings
Supporting both the manufacturing operations team and the automation team

Responsibilities

Writes and maintains good documentation practices, and ensures all documentation complies with all Federal and State accrediting agency requirements and/or GLP.
Writes standard operating procedures and maintains computer database. Performs second reviewer duties for SOPs.
Maintains lab equipment and related records and responsible for ordering and vendor management. Performs preventative maintenance checks and services equipment such as testing, calibrating, and cleaning.
Verifies samples received, logs samples into systems, and may transport to appropriate environment within the facility for storage following SOPs.
Writes process development reports and maintains computer database for each line of business.
Maintains material inventories, troubleshoots, and checks equipment to find malfunctioning or defective parts, and ensures all equipment and materials are ready for use.
Assists and trains staff on day-to-day lab operations, procedures, on the proper use and application of biomedical equipment.
Ensures all activities comply with regulatory guideline and safety standards.
Participates in research activities or protocols involving all aspects of the process, including investigation, technical, testing/validation of results, data analysis, and report findings.
Performs lab maintenance duties, including glassware cleaning and sterilization.