171 Oyster Point Blvd , Suite 500 South San Francisco, CA 94080 US
In this role, you will support key analytical and cell-based assays for release, in-process, and stability testing; participate in assay qualification/validation and transfer of analytical methods to determine the strength, purity and/or potency of viral vector preparations; Other activities may include data review and trending, SOP/protocol/report writing, lab/equipment maintenance, reagent preparation/supplies ordering, supporting EM and microbiology testing.
The successful candidate will work well across multiple projects in a fast-paced environment and be able to collaborate with the team to determine job assignments, perform work by the agreed upon date, and work with reviewer to ensure timely completion.
Final job title will be determined based on candidate experience level.
- Perform release, in-process, and stability testing in support of GMP Manufacturing activities (e.g., viral genome titer, capsid titer, cell-based assays, residual impurity characterization)
- Document, evaluate and review data and trend results
- Author and/or review standard operating procedures, technical protocols, and reports as needed
- Contribute to routine laboratory management and instrument maintenance and calibration
- Maintain general lab supplies and inventory, manage critical reagents preparation and inventory
- Support sample and data management
- Support contract testing lab management: sample shipments, obtain results, and follow up on open action items
- Bachelor’s or Master’s degree in Biology, Biochemistry, or a related field and a minimum of 1-3 years of hands-on laboratory experience in an assay development and/or QC laboratory environment
- Experience working in a cGMP environment is a plus
- Familiarity with one or more of the following is preferred: ddPCR, qPCR, ELISA, viral genome titer, capsid titer, cell-based transgene potency, residual impurity characterization, electrophoretic assays, or other immunochemical assays
- Follow written procedures and deliver results with a strong attention to detail.
- Excellent time management skills, able to multitask and drive projects forward in a timely manner and with minimal supervision.
- Strong judgement and communication skills, such as the ability to identify and proactively escalate issues immediately to management. For example, questions about in training, or something not performed according to SOP.
- Capable of lifting up to 40 pounds
- Target pay 35- 40 per hour, potentially more based on experience
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