Biomedical Scientist - Quality Control

Company: Cedars Sinai
Location: Los Angeles
Posted on: June 12, 2021

Job Description:

Share Requisition # HRC0519047

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

Cedars-Sinai Biomanufacturing Center (CBC) is a new 22,000 square feet, state-of-the-art biomanufacturing facility located in West Hollywood, California. The CBC comprises 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. These new therapies will be used for human IND-enabling clinical trials. With combined expertise in a cGMP-compliant approach to manufacture cells at scale, the CBC will overcome many challenges by building innovative technologies, connecting protocols, up-scaling of processes and achieving Food and Drug Administration standards for all steps involved to bring innovative cell therapy solutions to researchers and translation scientists. With our world-class expertise in stem cell (iPSC) biology, bioprocessing, translational medicine and manufacturing, the CBC is providing a much-needed biomanufacturing center in Southern California! To learn more, please visit: Biomanufacturing Center | Cedars-Sinai (cedars-sinai.edu)

The Biomedical Scientist will independently design, conduct, analyze and report studies that have been outlined by your supervisor or the Executive Director. This role will actively propose new avenues of investigation to Supervisor or Executive Director through investigation of the latest literature and new technologies. You will proactively assign projects, leads, and performs tasks and writes standard operating procedures (SOP)s, and are responsible for running assigned projects and managing associates activities in a regulated working environment, writing and recording controlled documents for projects and coordinate and assists QC team with all testing activities where required. In addition, you will supervise lab activities and will be responsible for providing training to other individuals who may be assigned to the project, study, or laboratory, as well as review and remain current on literature as it relates to clinical/research study.

Primary Duties & Responsibilities:

• Performs tasks related to the project and plans tasks, assigns work, monitors work, and identifies issues/problems, and makes plans to resolve problems.
• Performs and maintains good documentation practices, and ensures all documentation complies with Federal and State accrediting agency requirements, including Food and Drug Administration (FDA) requirements as necessary.
• Leads projects, trains and assists other associates on day-to-day lab operations and procedures. Monitors performance, completes performance appraisals, and addresses performance issues. Performs and trains associates project related activities.
• Performs a variety of Quality Control functions in support of cGMP aseptic Biological Drug manufacturing and process development. Quality Control testing will vary for each project based on the type of cells, tissues or organs.
• Ensures all activities comply with regulatory guidelines and safety standards by monitoring all ongoing activities and interacts with other teams within the organization regularly.
• Performs a broad range of tissue culture and microbiological methods, utilizing good aseptic techniques and lab practices in support of for developing, processing and manufacturing both research and clinical 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), Flow cytometry, Gene expression analysis, protein extraction, cell culture, immunocytochemistry, and staining.
• Expected to execute environmental monitoring (EM), QC analysis, provide technical oversite and complete routine record review of test data and related GMP documents under minimal supervision.
• Conduct investigations regarding EM action level excursions and out of specification (OOS) results for any QC-tests executed within the CBC or by external laboratories.
• Develop, revise and review SOPs, and monitor GMP systems currently in place to ensure compliance with documented policies.
• Must also have the ability to perform statistical analysis to generate trend reports on EM and product release data. Handwriting must be legible.
• Maintains compliance with established laboratory SOPs, GMP, MTA's and safety procedures.
• May perform the duties of the Biomedical Technician and must have a thorough understanding of laboratory and research functions.
• Train new staff on environmental monitoring, analytical and retain samples inventory management and analytical techniques when needed.
• Prepares written and verbal updates and findings, including slide presentations, and presents project updates.
• Assists with the scheduling of resources. Drafts overall timeline for projects.
• Supervises a laboratory or program with authority to make decision relevant to those programs.
• Writes and reviews SOPs and maintains computer database of established protocols.
• Maintains electronic and non-electronic records and adheres to GLP practices.

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Educational Requirements:

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

Experience and Skillset:

• Eight (8) years experience in GMP/GLP or equivalent regulated facility. Industrial experience is a plus.
• Experience with genus and species identification of various microbes, applying GMP in QC Lab, implementing CAPA and initiating change control is desirable.
• Knowledgeable in molecular biology techniques including mRNA, DNA extraction, RT-PCR, PCR, expression analysis.
• Experience with maintenance of analytical and retain sample inventory logs under GMP compliance.
• Must be well-organized, attentive to details with meticulous record keeping and a desire to ensure accurate results.
• Working Title: Biomedical Scientist - Quality Control
• 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: Full-time

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). 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 March each year) as a condition of employment, and annually thereafter as a condition of continued employment.

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