Csbiomfg

Job Title

Biomedical Specialist – Biomanufacturing Facility

Location

West Hollywood, California, United States

Job Description

The Cedars‑Sinai Biomanufacturing Center (CBC) is a state‑of‑the‑art facility that comprises 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 in project development for multiple projects, performs process development, validation, and qualification tasks associated with the project, may develop or aid in the writing of SOPs, performs project‑related techniques in accordance with established SOPs with accurate documentation, assists cross‑functional teams, proactively completes assigned projects, uses advanced knowledge to independently conduct, analyze, and report studies, provides communication, guidance, and advice that contributes to the success of projects, trains entry‑level staff, performs routine and increasingly complex laboratory tasks, develops technical expertise, orders and maintains lab equipment, manages vendors, and participates in research activities involving all aspects of the research or protocol process, including investigation, testing, validation, and reporting of results.

Primary Duties and Responsibilities

• Performs a variety of QC functions in support of cGMP aseptic biological drug manufacturing and process development.
• Performs a broad range of tissue culture and microbiological methods, utilizing good aseptic techniques and lab practices in support of developing, processing and manufacturing both research and clinical grade cellular products under established SOPs.
• Performs cellular, micro- and molecular biology procedures including, but not limited to Western blot, Northern blot, DNA/RNA analysis, PCR, flow cytometry, gene expression analysis, protein extraction, cell culture, immunocytochemistry, and staining.
• Executes environmental monitoring (EM), QC analysis, provides technical oversight, and reviews test data and GMP documents under minimal supervision.
• Investigates EM action level excursions and out‑of‑specification (OOS) results for QC tests executed within CBC or by external laboratories.
• Develops, revises, and reviews SOPs and monitors GMP systems to ensure compliance with documented policies.
• Performs statistical analysis to generate trend reports on environmental monitoring and product release data. Handwriting must be legible.
• Knowledgeable in molecular biology techniques including mRNA, DNA extraction, RT‑PCR, PCR, and expression analysis.
• Maintains compliance with laboratory SOPs, GMP, MTA’s, and safety procedures.
• Is well‑organized, detail‑oriented, with meticulous record keeping and a desire to ensure accurate results.
• Trains new staff on environmental monitoring, analytical techniques, and inventory management.

Qualifications

Education:

• Bachelor's Degree in biology, biochemistry, or related science or engineering specialization.

Experience and Skills:

• 2 years’ experience working in a laboratory or biomedical/biotech field.
• 2 years’ experience with biomedical equipment such as maintenance and/or testing.
• Experience with genus and species identification of various microbes, applying GMP in QC Lab, implementing CAPA, and initiating change control is highly desired.
• Experience maintaining analytical and retain sample inventory logs under GMP compliance is a plus.
• Demonstrated ability to apply cGMP knowledge to write procedures and manage projects.
• Prior experience working in an aseptic environment, biosafety cabinet, and with human and animal tissues.