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: Biomanufacturing Services | Cedars-Sinai (cedars-sinai.org)
The Associate Biomedical Scientist participates in project development and compliance of all Federal and State accrediting agency requirements, including Food and Drug Administration (FDA) requirements in good manufacturing practices (GMP) for cellular products in the CBC. As a Biomedical Scientist, provide guidance, evaluate client processes and make recommendations for improvement, while leading and performing a variety of cGMP manufacturing production and process development duties for multiple clients following SOPs for manufacturing processes that will be different for each project based on the type of cells, tissues or organs. This role is responsible for lab maintenance, handling of fresh and frozen cellular specimens and products using aseptic techniques and work within regulated cleanroom environment, writing and recording controlled documents and autoclaving for production.
Primary Duties & Responsibilities:
- 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 reviews SOPs, cGMP manufacturing production and process development reports while maintaining computer database for each line of business.
- May have independent supervision of a laboratory or program with authority to make decisions relevant to those programs.
- Performs project related techniques in accordance to established standard operating procedures.
- Maintains electronic and non-electronic records and adheres to GLP practices.
- Performs all cGMP related activities according to SOPs with accurate documentation.
- Assists QC team with all required testing activates. Proactively assigns projects and provides good communication to ensure successful completion.
- 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 adhere to regulatory guideline and safety standards.
- May take on specific team lead activities, and 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.
- 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) and shares knowledge, time and expertise to assist other members of the team.
- Responds timely, effectively and appropriately to deliverables
- Acts as a team lead to include supervising the work of others, assigning or allocating work to team, and ensuring tasks are completed according to deadlines and quality standards.
- Bachelor's Degree in molecular biology, biochemistry or related science/engineering field required. Master's degree, preferred.
Experience and Skillset:
- 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