Associate Biomedical Scientist - Biomanufacturing Center
Cedars-Sinai Medical Center
Location: Los Angeles, California
Internal Number: HRC0403365C
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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 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.
Will report directly to the PI and will independently develop and manage project plans including timelines and budgets for multiple projects.
Generate strategies that allow for clear and concise go/no-go decisions for projects.
Will co-ordinate with external groups and CRO's as needed to ensure project timelines and goals are met.
Write minutes and finalized reports to summarize interactions and data exchange.
Independently conduct hands-on laboratory research activities involving in vitro assay development, small and large molecule screening in the context of project plans and in-line with reviewed Gannt charts while maintaining updates and relevance.
Ensure awareness of latest technology and current standard practices.
Design, optimize & implement new biological assays where needed and keep abreast of new technologies that would assist in dissecting biological activities.
Ensure current equipment is maintained at best operational capacity and be responsible for regular maintenance.
Demonstrate proficiency in various, molecular biology and cellular immunology techniques, including cell culture, FACS, ELISA, luciferase assays, multiplex gene analysis and protein expression.
Generate reports and present data as needed.
Ensure data is effectively filed and saved in appropriate program folders in a secure location that is backed-up in a timely manner.
Optimize and qualify new assays.
Able to prepare for technology transfer and validation if needed.
Document work in lab notebooks, internal databases, prepare reports and present data.
Supervise summer students or associates where necessary and ensure associates are trained a proficient in all techniques and analysis. Guide associates on best practices and ensure all documentation is handled appropriately.
Author documents such as technical reports and SOPs as required.
Maintain compliance with safety training and documentation including training on SOPs
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
Working Title: Associate Biomedical Scientist - Biomanufacturing Center
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major t...eaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.