Operations Scientists run client testing at the bench under GMP. This role suits a scientist from a core laboratory or shared facility who likes running established assays well, on schedule, and with complete records. The work centers on seeding and maintaining human cells in microfluidic devices, running readouts, and recording every result in the LIMS.
Major Duties and Responsibilities
- Regulatory compliance: Perform all testing to approved SOPs under cGMP; follow good documentation practice; report deviations immediately and support investigations.
- Cell culture: Isolate, expand, and maintain human primary cells and cell lines under aseptic BSL2 conditions, using negative and positive pressure suites.
- Microfluidic operations: Prepare, seed, and perfuse microfluidic chips; set up and monitor pumps and flow; troubleshoot bubbles, leaks, and clogging.
- Study execution: Run Premiva readouts to SOP: live-cell video acquisition for potency and off-target binding, sample collection for cytokine multiplex and metabolites, flow cytometry for activation, adhesion, exhaustion, and CAR+ markers, and sample preparation and testing for NGS, ELISA, qPCR and flow cytometry.
- Conveying results through the LIMS: Enter raw data and test results in the LIMS at the time of testing, attach supporting files, and route results for review and approval.
- Report writing: Complete batch records, test records, and draft results summaries for Senior Scientist review.
- Customer interfacing: Join client calls when requested to describe methods and sample handling; coordinate sample shipments with client contacts.
- Sample handling and lab upkeep: Receive client samples, maintain chain of custody, manage inventory, and perform routine instrument checks, maintenance, and reagent qualification.
Education
Required Minimum Education
Requires Bachelor's or MS degree in biology, bioengineering, biomedical engineering, or a related field.
Licenses and/or Certifications
- Valid United States Driver's License
Experience
Required Minimum Experience
- Requires three years of laboratory experience or one year with a Masters Degree.
- Requires experience working in a core laboratory, shared facility, or service lab that runs studies for multiple internal or external clients.
- Requires hands-off experience with microfluidic devices or organ-on-chip systems.
- Requires hands-off experience culturing human cells, including primary cells, with strong aseptic technique.
Preferred Experience
- Experience with fluorescence or live-cell microscopy, flow cytometry, or multiplex cytokine assays preferred.
- Experience with T cells, peripheral blood mononuclear cells, or endothelial cells preferred.
- Experience entering results in a LIMS preferred.
- Experience working to SOPs with good documentation practice; GMP laboratory experience strongly preferred.
Experience Exception to Education
In some cases, an equivalency, consisting of a combination of appropriate education, training and or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Skills
- Must have clear written and verbal communication.