Requisition # HRC0769065A
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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: 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. 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.
- 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.
- 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.
- Working Title: Associate Biomedical Scientist – Biomanufacturing Center
- Department: CS Biomanufacturing Facility
- 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
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. If you need a reasonable accommodation for any part of the employment process, please contact us by email at Applicant_Accommodation@cshs.org and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.
At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu) and COVID-19. For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through April each year) as a condition of employment, and annually thereafter as a condition of continued employment, subject to medical exemption or religious accommodation. For the same reason, you may also be required to receive other vaccines such as COVID-19 as a condition of employment. Cedars-Sinai reserves the right to make modifications to its required list of vaccines as required by law and/or policy.