Biomedical Scientist - Quality Control
Company: Cedars Sinai
Location: Los Angeles
Posted on: June 12, 2021
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
- 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
- Train new staff on environmental monitoring, analytical and
retain samples inventory management and analytical techniques when
- 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
- Maintains electronic and non-electronic records and adheres to
- 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
Keywords: Cedars Sinai, Los Angeles , Biomedical Scientist - Quality Control, Other , Los Angeles, California
Didn't find what you're looking for? Search again!