The newly formed Precision Biomarkers Laboratory at Cedar-Sinai, is seeking a candidate with hands on experience in a mass spectrometry production laboratory to join us as a scientific leader in quantitative mass spectrometry expanding the use of proteomics in the diagnosis and treatment of human disease. Your experience with sample preparation workflows and analytical methods for proteins and peptides will be especially valuable. Housed in a brand-new laboratory equipped with state-of-the-art LC-MS/MS equipment, you will work in a team to achieve the highest performance. Your experience with multiple instruments will be a strong asset.

The Biomedical Specialist participates in project development for multiple clients and ensures compliance with all Federal and State accrediting agency requirements, including the Food and Drug Administration (FDA) requirements for good manufacturing practice (GMP) for cellular products in Cedars-Sinai Biomanufacturing Center (CBC). Performs all current good manufacturing practice (cGMP) related activities strictly according to SOPs, with accurate documentation, and assists quality control team with required testing activates. Proactively completes assigned projects, and uses GMP knowledge and experience to create good documentation and provide communication, guidance, and advice that contributes to the success of projects. Trains entry level staff on good manufacturing practices (cGMP)/GLP related activities. Performs routine and increasingly complex laboratory tasks and procedures and develops technical expertise in one or more areas relevant to research projects. Responsibilities include ordering and maintenance of lab equipment, and vendor management. Participates in research activities involving all aspects of the research or protocol process, including investigation, technical, testing/validation of results, and report findings.

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

Education:

Bachelor of Science in Molecular Biology, Biochemistry or related science/engineering field, required

Experience and Skillset:

• Two (2) years experience GMP/GLP or equivalent regulated facility
• Demonstrated ability to apply cGMP knowledge to write procedures and manage projects.
• Experience working in an aseptic environment, biosafety cabinet and 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.
• Identifies and responds appropriately to both internal and external customer needs utilizing available resources
• Collaborates to problem solve and make decisions to achieve desired outcomes
• Establishes effective working relationships with cross-functional team(s)
• Responds timely, effectively and appropriately to deliverables
• Shares knowledge, time and expertise to assist other members of the team

Additional Information:

• Working Title: Biomedical Specialist – Precision Biomarkers Lab
• Department: Precision Biomarker Labs
• Business Entity: Academic / Research
• City: Los Angeles
• Job Category: Biomanufacturing
• Job Specialty: Biomanufacturing
• Position Type: Full-time
• Shift Length: 8 hour shift
• Shift Type: Day