The Associate Scientist, Cell Manufacturing and Process Development will perform a broad range of tasks associated with the manufacture of cells for use in clinical and developmental studies. This resource will work as part of the team to execute Process Development Activities, plan and execute laboratory studies in order to support process development, characterization or process improvements
location: Pasadena, California
job type: Contract
salary: $35 - 40 per hour
work hours: 9 to 5
- Adheres to laboratory quality systems, batch records, SOPs, and cGMP regulations. Accurately completes documentation associated with development activities and sample analysis and records experiments in electronic lab notebook.
- Develops and executes protocols related to cell culture, processing and other activities as needed
- Assist with Technical Transfer of methods and procedures to the Cell Manufacturing department
- Perform analytical assays (ddPCR, CFU assay, Flow cytometry) to assist with Process development
- Drafts and reviews Standard Operating Procedures (SOPs), Batch Records, technical reports, and other documents for processes, equipment and test assays.
- Assists with testing and evaluation of new Equipment and commissioning.
- Assists with routine maintenance of scientific instrumentation, and equipment as required.
- Maintains current training status for all applicable activities.
- Provides feedback to Lead Scientist and Manager
- Presents experimental data at departmental or project meetings
- Works well in a team environment, collaborates well with various colleagues in other groups such as Bioanalytics, QA and Operations
- Ensures high safety standards are adhered to as governed by local, state and federal regulations, laws and policies
- Bachelor's degree (BS) or Master's degree (MS) Life Sciences (Cellular Biology, Immunology, or Biomedical)
- Familiarity with GMP manufacturing processes and working within a controlled environment
- 2+ years' experience in cell /gene therapy processing, familiarity with HSC is a plus
- Experience with analytical methods to characterize in process and final cell product samples (gene marking, CFU assay, flow cytometry)
- At least three years laboratory experience in biomedical research or a clinical laboratory with an emphasis on GMP practices, validation and execution of Laboratory SOPs and QC/QA practices.
- Experience in cell enrichment, culture, and cryopreservation of human HSPCs
- Three (3) years laboratory experience in biomedical research or a clinical laboratory with experience in Cellular Biology, Immunology, Hematology and/or Hematopoietic Stem and Progenitor Cell Biology (HSPC) preferred.
skills: Cell Biology, PCR, Flow Cytometry, Cell Cultures
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.