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Cedars-Sinai Biomedical Specialist - Manufacturing/Process Development - Biomanufacturing Center in Los Angeles, California

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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 GMP Biomanufacturing Services | Cedars-Sinai.

The Biomedical Specialist participates in project development for multiple projects and performs process development, validation, and qualification tasks associated with projects. This role will proactively complete assigned projects and uses advanced knowledge and experience to independently conduct, analyze and report studies. As a Biomedical Specialist, providing communication, guidance, and advice that contributes to the success of projects is expected, as well as training of entry-level staff for project-related activities. Additionally, this role will perform routine and increasingly complex laboratory tasks and procedures and develops technical expertise in one or more areas relevant to research projects. This position may be responsible for writing or aiding in the writing of SOPs for the project.

Primary Duties and Responsibilities

  • Performs a variety of cGMP manufacturing production and process development duties for multiple clients following standard operating procedures for manufacturing processes that will be different for each project based on the type of cells, tissues or organs.

  • Performs process development, validation, and qualifications for cellular production in GMP / good laboratory practice (GLP) environment for a variety of projects and cell lines.

  • 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 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.

  • Writes and maintains good documentation practices, and ensures all documentation compliances with all Federal and State accrediting agency requirements, including the Food and Drug Administration (FDA) requirements for good manufacturing practice (GMP) for cellular products.

  • 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.

  • Verifies samples received, logs samples into systems, and transports to appropriate environment within the facility for storage following SOPs.

  • Writes cGMP manufacturing production and process development reports and maintains computer database for each line of business.

  • Prepares cGMP production room, maintain material inventories, and ensures all equipment and materials are ready for productions.

  • Assists and trains staff on day-to-day lab operations, procedures, and cGMP processes and procedures.

  • 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, and report findings.

  • Performs lab maintenance duties, including glassware cleaning and sterilization.

Education:

  • Bachelor of Science degree in molecular biology, microbiology, biochemistry or related science/engineering field, required.

Experience and Skillset:

  • Two (2) years of experience in GMP/GLP regulated facility. Experience in an industrial scientific setting, preferred.

  • Demonstrated ability to apply cGMP knowledge to write procedures and manage projects.

  • Must have experience working in an aseptic environment

  • Must have experience working in a biosafety cabinet and have experience working with human and animal tissues.

  • Writes good documentation and standard operating procedures.

  • Knowledge of good manufacturing (GMP) practices for cellular products.

  • Knowledge of regulatory requirement including Federal, FDA, State and accrediting agency requirements.

  • Knowledge of specialized equipment and machinery to produce cellular products.

  • Ability to use databases.

Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.

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