Job Abstract

With your help, we can change the future of healthcare!

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. To learn more about the CBC, please visit Home - CSBIO (csbiomfg.com).

The Associate Biomedical Scientist will independently design, conduct, analyze and report studies that have been outlined by the supervisor. Reports to and works closely with Biomedical Scientist and/or Senior Biomedical Scientist to keep abreast of and develop new technologies. Writes and develops SOPs as needed. Supervises lab activities and is responsible for provide training to other individuals who may be assigned to the project, study, or laboratory. Responsible for lab maintenance, writing and recording controlled documents. May provide administrative leadership, and/or technical expertise. May develop hypothesis and assist in planning steps for the investigative process. Reviews and remains current on literature as it relates to clinical/research study. Performs all project related activities according to SOP(s) with accurate documentation. Assists cross functional teams with all required testing activates related to the project. Proactively assigns projects and provides good communication to ensure the success of projects. Excellent documentation skills and often leads execution of procedures, and functions.

Primary Duties & Responsibilities:

• Performs process development, validation, qualification tasks related to the project as needed. Provides guidance, evaluates client processes and makes recommendations for improvement.
• Performs tissue culture and aseptic techniques for developing and processing clinical grade and research grade cellular products in accordance to established standard operating procedures (SOP).
• Performs routine cellular, micro- and molecular biology procedures including, but not limited to Western blot, Northern blot, DNA / RNA, Polymerase chain reaction (PCR), protein extraction, cell culture, immunohistochemistry, and staining.
• Writers and maintains good documentation practices, and ensures compliance with Federal and State accrediting agency requirements, including the Food and Drug (FDA) requirements.
• Writes cGMP manufacturing production and process development reports and maintain computer database for each line of business.
• Writes and reveiws standard operating procedures and maintains computer database.
• Guides, trains and assists other manufacturing associates on day-to-day lab operations and procedures, and good manufacturing compliance.
• Performs lab maintenance duties, maintains lab equipment and related records, and vendor management.
• Requests batch records, transports, processes and logs samples following SOPs.
• Ensures all activities comply with regulatory guidelines and safety standards.
• May take on specific team lead activities, and provide administrative leadership, and/or technical expertise.

Education:

• Bachelor's Degree in molecular biology, biochemistry or related science/engineering field required. Master's degree, preferred.

Experience and Skills:

• Five (5) years experience in GMP/GLP or equivalent regulated facility. Scientific experience is a plus.
• Must have experience working in an aseptic environment, a biosafety cabinet and experience working with human and animal tissues.
• Ability to apply critical thinking to analyze and interpret information and/or data.
• Ability to convey and/or receive written/verbal information to/from various audiences in different formats.
• Ability to provide and/or support a level of work excellence and accuracy; recognize and address flaws or errors that others may overlook.
• Ability to apply advanced knowledge of science/learning/specialized intellectual instruction to analyze, interpret or make deductions from varying facts or circumstances.
• Ability to operate mechanical/medical devices and/or equipment.
• Ability to apply knowledge of information software and/or hardware to provide solutions and/or support.
• Ability to handle multiple demands and/or manage complex and competing priorities.
• Ability to motivate, monitor, measure, recognize and improve performance and morale.